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by Innolitics

  • Anesthesiology
    Review Panel
  • Cardiovascular
    Review Panel
  • Chemistry
    Review Panel
  • Dental
    Review Panel
  • Ear, Nose, Throat
    Review Panel
  • Gastroenterology and Urology
    Review Panel
  • General Hospital
    Review Panel
  • Hematology
    Review Panel
  • Immunology
    Review Panel
  • Microbiology
    Review Panel
  • Neurology
    Review Panel
  • Obstetrical and Gynecological
    Review Panel
  • Ophthalmic
    Review Panel
  • Orthopedic
    Review Panel
  • Pathology
    Review Panel
  • Physical Medicine
    Review Panel
  • Radiology
    Review Panel
  • General and Plastic Surgery
    Review Panel
    • Diagnostic Devices
      CFR Sub-Part
    • General Hospital and Personal Use Monitoring Devices
      CFR Sub-Part
    • General Hospital and Personal Use Therapeutic Devices
      CFR Sub-Part
    • Miscellaneous
      Miscellaneous
    • Neurological Surgical Devices
      CFR Sub-Part
    • Physical Medicine Therapeutic Devices
      CFR Sub-Part
    • Prosthetic Devices
      CFR Sub-Part
    • Surgical Devices
      CFR Sub-Part
      • EMF
        Knife, Surgical
        1
        Product Code
      • EPT
        Microscope, Surgical
        1
        Product Code
      • EPW
        Support, Head, Surgical, Ent
        1
        Product Code
      • OEJ
        Transurethral Electrosurgical Unit, Benign Prostatic Hyperplasia
        2
        Product Code
      • FAZ
        System, Cryosurgical, Liquid Nitrogen, For Urology
        2
        Product Code
      • OEK
        Water-Induced Thermotherapy System, Benign Prostatic Hyperplasia
        2
        Product Code
      • GAG
        Stapler, Surgical
        2
        Product Code
      • DWG
        Electrosurgical Device
        2
        Product Code
      • DWH
        Blade, Saw, Surgical, Cardiovascular
        1
        Product Code
      • DWI
        Saw, Electrically Powered
        1
        Product Code
      • DWO
        Needle, Biopsy, Cardiovascular
        1
        Product Code
      • QQS
        Stapler, Skin
        1
        Product Code
      • BTA
        Pump, Portable, Aspiration (Manual Or Powered)
        2
        Product Code
      • BWA
        Unit, Electrosurgical And Coagulation, With Accessories
        2
        Product Code
      • BWN
        Table And Attachments, Operating-Room
        1
        Product Code
      • BWP
        Shoe And Shoe Cover, Conductive
        1
        Product Code
      • FGY
        Cannula, Injection
        1
        Product Code
      • FHM
        Apparatus, Suturing, Stomach And Intestinal
        1
        Product Code
      • FHR
        Needle, Gastro-Urology
        1
        Product Code
      • FMK
        Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
        2
        Product Code
      • FNW
        Pad, Kelly
        2
        Product Code
      • FQO
        Table, Operating-Room, Ac-Powered
        1
        Product Code
      • FQP
        Lamp, Operating-Room
        2
        Product Code
      • FSE
        Table, Operating-Room, Manual
        1
        Product Code
      • FSH
        Tray, Surgical, Needle
        1
        Product Code
      • FSM
        Tray, Surgical, Instrument
        1
        Product Code
      • FSO
        Microscope, Surgical, General & Plastic Surgery
        1
        Product Code
      • FSP
        Loupe, Diagnostic/Surgical
        1
        Product Code
      • FSQ
        Light, Surgical, Instrument
        2
        Product Code
      • FSS
        Light, Surgical, Floor Standing
        2
        Product Code
      • FST
        Light, Surgical, Fiberoptic
        2
        Product Code
      • FSW
        Light, Surgical, Endoscopic
        2
        Product Code
      • FSX
        Light, Surgical, Connector
        2
        Product Code
      • FSY
        Light, Surgical, Ceiling Mounted
        2
        Product Code
      • FSZ
        Light, Surgical, Carrier
        2
        Product Code
      • FTA
        Light, Surgical, Accessories
        2
        Product Code
      • FTC
        Light, Ultraviolet, Dermatological
        2
        Product Code
      • FTD
        Lamp, Surgical
        2
        Product Code
      • FTF
        Illuminator, Non-Remote
        2
        Product Code
      • FTG
        Illuminator, Remote
        2
        Product Code
      • FTH
        Camera, Still, Microsurgical
        1
        Product Code
      • FTS
        Camera, Cine, Endoscopic, With Audio
        1
        Product Code
      • FTT
        Camera, Still, Surgical
        1
        Product Code
      • FTX
        Mirror, General & Plastic Surgery
        1
        Product Code
      • FTY
        Tape, Measuring, Rulers And Calipers
        1
        Product Code
      • FWB
        Camera, Television, Surgical, Without Audio
        1
        Product Code
      • FWC
        Camera, Television, Surgical, With Audio
        1
        Product Code
      • FWD
        Camera, Television, Microsurgical, Without Audio
        1
        Product Code
      • FWE
        Camera, Television, Microsurgical, With Audio
        1
        Product Code
      • FWF
        Camera, Television, Endoscopic, Without Audio
        1
        Product Code
      • FWG
        Camera, Television, Endoscopic, With Audio
        1
        Product Code
      • FWH
        Camera, Cine, Surgical, Without Audio
        1
        Product Code
      • FWI
        Camera, Cine, Surgical, With Audio
        1
        Product Code
      • FWJ
        Camera, Cine, Microsurgical, Without Audio
        1
        Product Code
      • FWK
        Camera, Cine, Microsurgical, With Audio
        1
        Product Code
      • FWL
        Camera, Cine, Endoscopic, Without Audio
        1
        Product Code
      • FWW
        Table, Operating-Room, Pneumatic
        1
        Product Code
      • FWX
        Table, Operating-Room, Mechanical
        1
        Product Code
      • FWY
        Table, Operating-Room, Non-Electrical
        1
        Product Code
      • FWZ
        Operating Room Accessories Table Tray
        1
        Product Code
      • FXM
        Camera, Still, Endoscopic
        1
        Product Code
      • FXN
        Tape, Camera, Surgical
        1
        Product Code
      • FXQ
        Lens, Camera, Surgical
        1
        Product Code
      • FXR
        Holder, Camera, Surgical
        1
        Product Code
      • FXS
        Frame, Camera, Surgical
        1
        Product Code
      • FXT
        Film, Camera, Surgical
        1
        Product Code
      • FXW
        Shoes, Operating-Room
        1
        Product Code
      • FYE
        Dress, Surgical
        1
        Product Code
      • FYF
        Cap, Surgical
        1
        Product Code
      • FZK
        Chair, Surgical, Non-Electrical
        1
        Product Code
      • FZM
        Stool, Operating-Room
        1
        Product Code
      • FZO
        Chisel, Surgical, Manual
        1
        Product Code
      • FZP
        Clip, Implantable
        2
        Product Code
      • FZQ
        Clip, Removable (Skin)
        1
        Product Code
      • FZR
        Contractor, Surgical
        1
        Product Code
      • FZS
        Curette, Surgical, General Use
        1
        Product Code
      • FZT
        Cutter, Surgical
        1
        Product Code
      • FZW
        Expander, Surgical, Skin Graft
        1
        Product Code
      • FZX
        Guide, Surgical, Instrument
        1
        Product Code
      • FZY
        Hammer, Surgical
        1
        Product Code
      • FZZ
        Marker, Skin
        1
        Product Code
      • GAA
        Needle, Aspiration And Injection, Disposable
        1
        Product Code
      • GAB
        Needle, Suturing, Disposable
        1
        Product Code
      • GAC
        Rasp, Surgical, General & Plastic Surgery
        1
        Product Code
      • GAD
        Retractor
        1
        Product Code
      • GAE
        Snare, Surgical
        1
        Product Code
      • GAF
        Spatula, Surgical, General & Plastic Surgery
        1
        Product Code
      • GAH
        Stylet, Surgical, General & Plastic Surgery
        1
        Product Code
      • GAI
        Stripper, Vein, Reusable
        1
        Product Code
      • GAJ
        Stripper, Vein, Disposable
        1
        Product Code
      • GAK
        Suture, Absorbable
        2
        Product Code
      • GAL
        Suture, Absorbable, Natural
        2
        Product Code
      • GAM
        Suture, Absorbable, Synthetic, Polyglycolic Acid
        2
        Product Code
      • GAN
        Suture, Absorbable, Synthetic
        2
        Product Code
      • GAO
        Suture, Nonabsorbable
        2
        Product Code
      • GAP
        Suture, Nonabsorbable, Silk
        2
        Product Code
      • GAQ
        Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
        2
        Product Code
      • GAR
        Suture, Nonabsorbable, Synthetic, Polyamide
        2
        Product Code
      • GAS
        Suture, Nonabsorbable, Synthetic, Polyester
        2
        Product Code
      • GAT
        Suture, Nonabsorbable, Synthetic, Polyethylene
        2
        Product Code
      • GAW
        Suture, Nonabsorbable, Synthetic, Polypropylene
        2
        Product Code
      • GBA
        Catheter, Balloon Type
        1
        Product Code
      • GBB
        Chair, Surgical, Ac-Powered
        1
        Product Code
      • GBC
        Lamp, Surgical, Incandescent
        2
        Product Code
      • GBN
        Catheter, Pediatric, General & Plastic Surgery
        1
        Product Code
      • GBO
        Catheter, Nephrostomy, General & Plastic Surgery
        1
        Product Code
      • GBP
        Catheter, Multiple Lumen
        1
        Product Code
      • GBQ
        Catheter, Continuous Irrigation
        1
        Product Code
      • GBS
        Catheter, Ventricular, General & Plastic Surgery
        1
        Product Code
      • GBW
        Catheter, Peritoneal
        1
        Product Code
      • GBX
        Catheter, Irrigation
        1
        Product Code
      • GBY
        Catheter, Eustachian, General & Plastic Surgery
        1
        Product Code
      • GBZ
        Catheter, Cholangiography
        1
        Product Code
      • GCB
        Needle, Catheter
        1
        Product Code
      • GCC
        Dilator, Catheter
        1
        Product Code
      • GCD
        Connector, Catheter
        1
        Product Code
      • GCE
        Adaptor, Catheter
        1
        Product Code
      • GCY
        Apparatus, Suction, Single Patient Use, Portable, Nonpowered
        1
        Product Code
      • GCZ
        Retainer, Surgical
        1
        Product Code
      • GDC
        Table, Operating-Room, Electrical
        1
        Product Code
      • GDF
        Guide, Needle, Surgical
        1
        Product Code
      • GDG
        Hook, Surgical, General & Plastic Surgery
        1
        Product Code
      • GDH
        Gouge, Surgical, General & Plastic Surgery
        1
        Product Code
      • GDI
        Dissector, Surgical, General & Plastic Surgery
        1
        Product Code
      • GDJ
        Clamp, Surgical, General & Plastic Surgery
        1
        Product Code
      • GDL
        Needle, Suturing, Reusable
        1
        Product Code
      • GDM
        Needle, Aspiration And Injection, Reusable
        1
        Product Code
      • GDN
        Knife, Amputation
        1
        Product Code
      • GDO
        Applier, Surgical, Clip
        1
        Product Code
      • GDR
        Saw, Manual And Accessories
        1
        Product Code
      • GDT
        Staple, Removable (Skin)
        1
        Product Code
      • GDW
        Staple, Implantable
        2
        Product Code
      • GDX
        Scalpel, One-Piece
        1
        Product Code
      • GDY
        Gauze/Sponge, Internal, X-Ray Detectable
        1
        Product Code
      • GDZ
        Handle, Scalpel
        1
        Product Code
      • GEA
        Cannula, Surgical, General & Plastic Surgery
        1
        Product Code
      • GEC
        Brush, Scrub, Operating-Room
        1
        Product Code
      • GED
        Brush, Dermabrasion, Manual
        1
        Product Code
      • GEE
        Brush, Biopsy, General & Plastic Surgery
        1
        Product Code
      • GEF
        Applier, Staple, Surgical,
        1
        Product Code
      • GEG
        Elevator, Surgical, General & Plastic Surgery
        1
        Product Code
      • GEH
        Unit, Cryosurgical, Accessories
        2
        Product Code
      • GEI
        Electrosurgical, Cutting & Coagulation & Accessories
        2
        Product Code
      • GEJ
        Carrier, Ligature
        1
        Product Code
      • GEN
        Forceps, General & Plastic Surgery
        1
        Product Code
      • GEO
        File, Surgical, General & Plastic Surgery
        1
        Product Code
      • GES
        Blade, Scalpel
        1
        Product Code
      • GET
        Motor, Surgical Instrument, Pneumatic Powered
        1
        Product Code
      • GEX
        Powered Laser Surgical Instrument
        2
        Product Code
        • K220793
          InnoVoyce Laser Fiber
          2
          Cleared 510(K)
        • K220381
          Diode Laser Therapy Systems
          2
          Cleared 510(K)
        • K211534
          RevoLix HTL
          2
          Cleared 510(K)
        • K220467
          The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories
          2
          Cleared 510(K)
        • K220041
          HandPICO
          2
          Cleared 510(K)
        • K213594
          ECHOLASER X4
          2
          Cleared 510(K)
        • K220189
          LISA Laser Surgical Fibers
          2
          Cleared 510(K)
        • K213889
          PicoStar
          2
          Cleared 510(K)
        • K210183
          Waterlase iPLus
          2
          Cleared 510(K)
        • K213484
          SmoothCool HR System
          2
          Cleared 510(K)
        • K213350
          mJOULE System and Accessories
          2
          Cleared 510(K)
        • K210634
          MCL 31 Dermablate System
          2
          Cleared 510(K)
        • K220103
          LED Therapy Device (Planar LED/Planar LED mini)
          2
          Cleared 510(K)
        • K213557
          Finexel
          2
          Cleared 510(K)
        • K211681
          EON
          2
          Cleared 510(K)
        • K213461
          AviClear Laser System
          2
          Cleared 510(K)
        • K220426
          Fiber Dust PRO
          2
          Cleared 510(K)
        • K211722
          Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares
          2
          Cleared 510(K)
        • K220020
          Cryo 7
          2
          Cleared 510(K)
        • K213569
          HOLLYWOOD SPECTRA Laser System
          2
          Cleared 510(K)
        • K213554
          Sentient Manufacturing Laser Fiber
          2
          Cleared 510(K)
        • K211228
          Rosso
          2
          Cleared 510(K)
        • K212611
          CO2 Laser Equipment
          2
          Cleared 510(K)
        • K203395
          Platform treatment system
          2
          Cleared 510(K)
        • K212478
          Dermatological diode laser system
          2
          Cleared 510(K)
        • K212127
          Picocaremajesty
          2
          Cleared 510(K)
        • K213225
          Diode Laser System GP900A8, Diode Laser System GP900Q8
          2
          Cleared 510(K)
        • K212492
          Frax 1940 for Nordlys and Frax Pro
          2
          Cleared 510(K)
        • K202848
          S2 Pigment Removal System
          2
          Cleared 510(K)
        • K210847
          UltraClear Fractional Laser System
          2
          Cleared 510(K)
        • K212573
          PicoLO Premium
          2
          Cleared 510(K)
        • K202175
          OxyLight 2.0
          2
          Cleared 510(K)
        • K202288
          Finebeam
          2
          Cleared 510(K)
        • K212607
          Darwin
          2
          Cleared 510(K)
        • K212978
          Diode laser therapy system
          2
          Cleared 510(K)
        • K211517
          Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessorie
          2
          Cleared 510(K)
        • K212502
          Resonic Rapid Acoustic Pulse Device
          2
          Cleared 510(K)
        • K211977
          Medical Diode Laser Systems
          2
          Cleared 510(K)
        • K202998
          Vydence Zye and Vydence One
          2
          Cleared 510(K)
        • K212793
          Laser Treatment System, Model: Hera, Armo
          2
          Cleared 510(K)
        • K211735
          CO2 Laser Machine, Model: BW-203B
          2
          Cleared 510(K)
        • K212270
          DEKA LipoAI
          2
          Cleared 510(K)
        • K212703
          AcuPulse CO2 Laser System, Delivery Devices and Accessories
          2
          Cleared 510(K)
        • K201773
          PICOHI
          2
          Cleared 510(K)
        • K212082
          Picore
          2
          Cleared 510(K)
        • K203799
          ProFlex CO2 Laser Fiber
          2
          Cleared 510(K)
        • K211637
          AROMA GRAND
          2
          Cleared 510(K)
        • K210951
          Leonardo Mini Blue
          2
          Cleared 510(K)
        • K211362
          SCAR 3
          2
          Cleared 510(K)
        • K211761
          UltraLase Flexible CO2 Laser Waveguide
          2
          Cleared 510(K)
        • K211335
          Diode Laser Machine, Model Number: BM-100
          2
          Cleared 510(K)
        • K203728
          Darwin
          2
          Cleared 510(K)
        • K211821
          DEKA Motus AZ
          2
          Cleared 510(K)
        • K203441
          The Alma Hybrid Laser System
          2
          Cleared 510(K)
        • K202991
          Fotona XPulse Pro Laser Platform
          2
          Cleared 510(K)
        • K202828
          Surgical Green Laser System
          2
          Cleared 510(K)
        • K211401
          SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
          2
          Cleared 510(K)
        • K210535
          UltraLight LED System
          2
          Cleared 510(K)
        • K210168
          Diode Laser Therapy Systems
          2
          Cleared 510(K)
        • K210925
          Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber
          2
          Cleared 510(K)
        • K210964
          Resonic Rapid Acoustic Pulse Device
          2
          Cleared 510(K)
        • K210663
          Dermatological Diode Laser Systems
          2
          Cleared 510(K)
        • K202258
          ERISE Laser handpiece
          2
          Cleared 510(K)
        • K202257
          Dermatological Diode Laser Systems
          2
          Cleared 510(K)
        • K202043
          Secret Duo
          2
          Cleared 510(K)
        • K203491
          PicoLO Nd: YAG Picosecond Laser System
          2
          Cleared 510(K)
        • K201171
          LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable
          2
          Cleared 510(K)
        • K210226
          PicoSure Workstation
          2
          Cleared 510(K)
        • K203788
          DermaV Laser System
          2
          Cleared 510(K)
        • K201466
          Tranberg CLS Laser Applicator
          2
          Cleared 510(K)
        • K202985
          LightWalker Laser System Family
          2
          Cleared 510(K)
        • K210142
          Fiber Dust
          2
          Cleared 510(K)
        • K203054
          FlexSys
          2
          Cleared 510(K)
        • K210033
          Laser Treatment System, Model: NYX and Grace
          2
          Cleared 510(K)
        • K202702
          FLARE Single-Use Surgical Laser Fiber
          2
          Cleared 510(K)
        • K203804
          Global Med Systems Milesman Compact Laser
          2
          Cleared 510(K)
        • K201801
          Rapid Acoustic Pulse Device
          2
          Cleared 510(K)
        • K193266
          MIIN
          2
          Cleared 510(K)
        • K203241
          OmniGuide BeamPath OTO-U Fiber
          2
          Cleared 510(K)
        • K203544
          UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories
          2
          Cleared 510(K)
        • K201594
          Primelase Excellence
          2
          Cleared 510(K)
        • K202601
          Single-use Sterile medical laser fiber
          2
          Cleared 510(K)
        • K201687
          Avenda Health Treatment System
          2
          Cleared 510(K)
        • K202250
          Dermatological Carbon Dioxide Laser Systems
          2
          Cleared 510(K)
        • K202980
          Laser Therapy Device
          2
          Cleared 510(K)
        • K202172
          StarWalker
          2
          Cleared 510(K)
        • K200693
          K2 MOBILE
          2
          Cleared 510(K)
        • K202503
          Chrome
          2
          Cleared 510(K)
        • K202758
          Nd: YAG Laser Therapy Systems HM-YL900
          2
          Cleared 510(K)
        • K202428
          AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
          2
          Cleared 510(K)
        • K202041
          Opera Evo
          2
          Cleared 510(K)
        • K201056
          NeuroBlate System
          2
          Cleared 510(K)
        • K201406
          Picowon
          2
          Cleared 510(K)
        • K201663
          AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
          2
          Cleared 510(K)
        • K201109
          CO2 Laser Therapy System
          2
          Cleared 510(K)
        • K201455
          Litho 150, Cyber Ho 150
          2
          Cleared 510(K)
        • K200736
          Stardust Med
          2
          Cleared 510(K)
        • K193477
          Nd: YAG Laser Therapy Systems
          2
          Cleared 510(K)
        • K200786
          Venus Epileve
          2
          Cleared 510(K)
        • K200042
          CO2 Laser System
          2
          Cleared 510(K)
        • K200104
          Oxylight
          2
          Cleared 510(K)
        • K200116
          PicoSecond Nd: YAG Laser System
          2
          Cleared 510(K)
        • K200525
          Medical Diode Laser Hair Removal System
          2
          Cleared 510(K)
        • K201111
          GentleMax Pro Plus
          2
          Cleared 510(K)
        • K200751
          Photodynamic Therapy (PDT) Equipment
          2
          Cleared 510(K)
        • K200659
          Dermalux Tri-Wave MD
          2
          Cleared 510(K)
        • K192856
          MT One
          2
          Cleared 510(K)
        • K200118
          Diode Laser Therapy Device
          2
          Cleared 510(K)
        • K193464
          ND:YAG Laser
          2
          Cleared 510(K)
        • K191970
          Diode Laser Hair Removal System
          2
          Cleared 510(K)
        • K192735
          Diode Laser Hair Removal Machine
          2
          Cleared 510(K)
        • K193656
          SkyPulse
          2
          Cleared 510(K)
        • K192951
          Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun
          2
          Cleared 510(K)
        • K193661
          LightWalker Laser System Family
          2
          Cleared 510(K)
        • K193609
          Q Switched Nd: YAG Laser machine
          2
          Cleared 510(K)
        • K192272
          Wolf445nm
          2
          Cleared 510(K)
        • K200110
          SANDRO Dual
          2
          Cleared 510(K)
        • K193486
          Epic 980
          2
          Cleared 510(K)
        • K192483
          MeDioStar
          2
          Cleared 510(K)
        • K193367
          elysion-pro
          2
          Cleared 510(K)
        • K200331
          Rapid Acoustic Pulse Device
          2
          Cleared 510(K)
        • K193446
          Bare: 808
          2
          Cleared 510(K)
        • K193426
          Elite iQ
          2
          Cleared 510(K)
        • K200234
          Surgical laser fibers
          2
          Cleared 510(K)
        • K192600
          Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60
          2
          Cleared 510(K)
        • K192617
          Gemini 810+980 Soft Tissue Laser
          2
          Cleared 510(K)
        • K192583
          PicoLazer Laser System
          2
          Cleared 510(K)
        • K193500
          Stellar M22 for Intense Pulsed Light (IPL) and Laser System
          2
          Cleared 510(K)
        • K193478
          XTRAC Momentum Excimer Laser System
          2
          Cleared 510(K)
        • K193375
          NeuroBlate System
          2
          Cleared 510(K)
        • K191501
          PALLAS 308/311 Solid-State UV Laser System
          2
          Cleared 510(K)
        • K192990
          Litho Evo
          2
          Cleared 510(K)
        • K192755
          Soli-Lite LG4 Galileo
          2
          Cleared 510(K)
        • K192539
          Deka Luxea
          2
          Cleared 510(K)
        • K192569
          Diode Laser Therapy System
          2
          Cleared 510(K)
        • K192516
          Diode Laser 808nm
          2
          Cleared 510(K)
        • K191962
          Vitra 2
          2
          Cleared 510(K)
        • K192430
          Epic 980
          2
          Cleared 510(K)
        • K192528
          CO2 Laser Therapy System
          2
          Cleared 510(K)
        • K192269
          TwinScan 808/755 Laser System
          2
          Cleared 510(K)
        • K192331
          LaseMD LEO Laser System
          2
          Cleared 510(K)
        • K191693
          BC-5
          2
          Cleared 510(K)
        • K191942
          MT One Diamond
          2
          Cleared 510(K)
        • K190319
          Waterlase Laser System Family
          2
          Cleared 510(K)
        • K191842
          Discovery Pico, Discovery Pico Plus, Discovery Pico Derm
          2
          Cleared 510(K)
        • K191685
          PicoWay Laser System
          2
          Cleared 510(K)
        • K191518
          CO2 Laser System
          2
          Cleared 510(K)
        • K181602
          Pioneer Elite Diode Laser
          2
          Cleared 510(K)
        • K181614
          Sterling Supreme Diode Laser
          2
          Cleared 510(K)
        • K181601
          Precise SHP Diode Laser
          2
          Cleared 510(K)
        • K192160
          EVO Platform
          2
          Cleared 510(K)
        • K183563
          Holinwon 30
          2
          Cleared 510(K)
        • K191554
          LightWalker Laser System Family
          2
          Cleared 510(K)
        • K183122
          810nm Diode Laser System
          2
          Cleared 510(K)
        • K191349
          980nm Diode Laser Therapy Device
          2
          Cleared 510(K)
        • K183647
          SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)
          2
          Cleared 510(K)
        • K191321
          Primelase Excellence
          2
          Cleared 510(K)
        • K191611
          Diode Laser Therapy Systems
          2
          Cleared 510(K)
        • K182930
          PerioLase Nd:YAG Pulsed Dental Laser System
          2
          Cleared 510(K)
        • K191162
          EpiLaze Multi-wavelength Laser
          2
          Cleared 510(K)
        • K190938
          Photodynamic Therapy System
          2
          Cleared 510(K)
        • K190936
          Q-Switched Nd: YAG Laser System
          2
          Cleared 510(K)
        • K183566
          CLARITY II Laser System
          2
          Cleared 510(K)
        • K180511
          eon
          2
          Cleared 510(K)
        • K190542
          Soliton Acoustic Wave Device
          2
          Cleared 510(K)
        • K183199
          TRIO Handpiece
          2
          Cleared 510(K)
        • K183156
          V-Laser
          2
          Cleared 510(K)
        • K182924
          Diode Laser Treatment System
          2
          Cleared 510(K)
        • K190392
          WaveLight FS200 Patient Interface
          2
          Cleared 510(K)
        • K182173
          Joule System
          2
          Cleared 510(K)
        • K190007
          Vydence Laser Family
          2
          Cleared 510(K)
        • K183452
          Vbeam Prima Laser System
          2
          Cleared 510(K)
        • K183392
          PicoLO Nd:YAG Picosecond Laser System
          2
          Cleared 510(K)
        • K182045
          Lotus III Multi-Pulsed Er: Yag Laser System
          2
          Cleared 510(K)
        • K182997
          enlighten III Laser System
          2
          Cleared 510(K)
        • K183307
          Magma Spark Pro (Magma Spark Plus, Alpha)
          2
          Cleared 510(K)
        • K182831
          SabreLine and SabreGuard Laser Fibers
          2
          Cleared 510(K)
        • K182663
          Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System
          2
          Cleared 510(K)
        • K182604
          New Era
          2
          Cleared 510(K)
        • K182270
          Cellene CO2 Laser System
          2
          Cleared 510(K)
        • K182088
          XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro
          2
          Cleared 510(K)
        • K182669
          Youlaser CO2
          2
          Cleared 510(K)
        • K182036
          NeuroBlate System
          2
          Cleared 510(K)
        • K181867
          Deka Smartxide2 Trio
          2
          Cleared 510(K)
        • K181632
          Venacure 1470 Pro
          2
          Cleared 510(K)
        • K173827
          LightScalpel
          2
          Cleared 510(K)
        • K173676
          A-FIT
          2
          Cleared 510(K)
        • K181662
          Iridex TruFocus LIO Premiere
          2
          Cleared 510(K)
        • K181510
          ECHOLASER X4
          2
          Cleared 510(K)
        • K181486
          DEKA Motus AY
          2
          Cleared 510(K)
        • K181480
          MMD Tip
          2
          Cleared 510(K)
        • K181272
          Picocare Family
          2
          Cleared 510(K)
        • K181431
          Laser Ureteral Catheter
          2
          Cleared 510(K)
        • K180518
          GME LinScan Lite 808 Laser System
          2
          Cleared 510(K)
        • K181019
          Diode Laser System
          2
          Cleared 510(K)
        • K181523
          Syneron CO2RE System
          2
          Cleared 510(K)
        • K180967
          Dental Diode Laser System
          2
          Cleared 510(K)
        • K181044
          400um Perforator and Accessory Vein Ablation Kit
          2
          Cleared 510(K)
        • K173359
          Fractional CO2 Surgical Laser System
          2
          Cleared 510(K)
        • K180993
          Beacon Advanced CO2 Laser System
          2
          Cleared 510(K)
        • K173700
          PICOPLUS Laser System
          2
          Cleared 510(K)
        • K180719
          InMode Diolaze System
          2
          Cleared 510(K)
        • K180593
          Vbeam Prima Laser System
          2
          Cleared 510(K)
        • K180508
          JOULE SYSTEM
          2
          Cleared 510(K)
        • K180922
          Empower H100, Cyber Ho 100, Litho 100
          2
          Cleared 510(K)
        • K180140
          ProFlex Laser Fibers
          2
          Cleared 510(K)
        • K171443
          Etherea MX
          2
          Cleared 510(K)
        • K180353
          Diode laser hair removal device
          2
          Cleared 510(K)
        • K180597
          AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO
          2
          Cleared 510(K)
        • K180426
          Empower H35
          2
          Cleared 510(K)
        • K180423
          Empower H65
          2
          Cleared 510(K)
        • K180406
          Ellipse Ydun
          2
          Cleared 510(K)
        • K180224
          ELEMENT-TL
          2
          Cleared 510(K)
        • K180044
          SIROLaser Blue
          2
          Cleared 510(K)
        • K180350
          Dornier Medilas H Solvo 35 Laser
          2
          Cleared 510(K)
        • K172818
          LMT-3000
          2
          Cleared 510(K)
        • K173677
          InMode VLaze
          2
          Cleared 510(K)
        • K173067
          LightForce LTS Model 1000, 1500, 2500, and 4000
          2
          Cleared 510(K)
        • K180193
          DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)
          2
          Cleared 510(K)
        • K180158
          Surgical Laser fibers
          2
          Cleared 510(K)
        • K172439
          Siberian Fit
          2
          Cleared 510(K)
        • K173199
          PicoSure Workstation
          2
          Cleared 510(K)
        • K173285
          JOULE SYSTEM
          2
          Cleared 510(K)
        • K172193
          Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules
          2
          Cleared 510(K)
        • K173002
          2940 nm Er:Yag Laser Handpiece
          2
          Cleared 510(K)
        • K172908
          Q-Switched Nd:YAG Laser System
          2
          Cleared 510(K)
        • K173038
          CuRAS Nd:YAG Laser
          2
          Cleared 510(K)
        • K172819
          LightWalker Laser System Family
          2
          Cleared 510(K)
        • K172771
          Epic Pro 940
          2
          Cleared 510(K)
        • K173169
          Rapid Family
          2
          Cleared 510(K)
        • K173305
          NeuroBlate System
          2
          Cleared 510(K)
        • K172362
          DEKA SMARTXIDE TOUCH
          2
          Cleared 510(K)
        • K172363
          DEKA SMARTXIDE ULTRASPEED
          2
          Cleared 510(K)
        • K172639
          PALLAS 308/311 Solid-State UV Laser System
          2
          Cleared 510(K)
        • K172077
          Cutera enlighten III Laser System
          2
          Cleared 510(K)
        • K172325
          Rhapsody H-30 Holmium Laser System
          2
          Cleared 510(K)
        • K172881
          NeuroBlate System
          2
          Cleared 510(K)
        • K172376
          Discovery Pico, Discovery Pico Plus
          2
          Cleared 510(K)
        • K172198
          585
          2
          Cleared 510(K)
        • K172413
          MT ONE
          2
          Cleared 510(K)
        • K171986
          Sterling Supreme Diode Laser
          2
          Cleared 510(K)
        • K170179
          LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity
          2
          Cleared 510(K)
        • K170409
          PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System
          2
          Cleared 510(K)
        • K171648
          BM.IRIS
          2
          Cleared 510(K)
        • K170970
          Epilaser
          2
          Cleared 510(K)
        • K171921
          VenaCure EVLT NeverTouch Procedure Kit
          2
          Cleared 510(K)
        • K171227
          StarWalker
          2
          Cleared 510(K)
        • K172096
          Fraxis
          2
          Cleared 510(K)
        • K170060
          M22 and ResurFx Systems
          2
          Cleared 510(K)
        • K170738
          InMode Diolaze XL
          2
          Cleared 510(K)
        • K171079
          Q-Switched Nd:YAG Laser System
          2
          Cleared 510(K)
        • K172025
          Litho 60
          2
          Cleared 510(K)
        • K171945
          Discovery Pico, Discovery Pico Plus
          2
          Cleared 510(K)
        • K170187
          Photodynamic Therapy Device
          2
          Cleared 510(K)
        • K171255
          Monteris Medical NeuroBlate System
          2
          Cleared 510(K)
        • K170073
          LightMed Dental Laser System
          2
          Cleared 510(K)
        • K171711
          Thunder, Thunder VT, Thunder HR
          2
          Cleared 510(K)
        • K171009
          LASEMD Laser System
          2
          Cleared 510(K)
        • K163449
          HyPHo Laser System
          2
          Cleared 510(K)
        • K162886
          DEKA MOTUS AX
          2
          Cleared 510(K)
        • K162659
          Diode Laser Hair Removal System
          2
          Cleared 510(K)
        • K170850
          Alma Q
          2
          Cleared 510(K)
        • K162755
          Picocare
          2
          Cleared 510(K)
        • K170366
          Laser Peripherals, LLC Family of Bare Laser Fibers
          2
          Cleared 510(K)
        • K170626
          Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece
          2
          Cleared 510(K)
        • K170597
          PicoWay Laser System
          2
          Cleared 510(K)
        • K163197
          Cook Holmium Laser Fiber
          2
          Cleared 510(K)
        • K163196
          ACTION II Laser System
          2
          Cleared 510(K)
        • K170121
          Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories
          2
          Cleared 510(K)
        • K160677
          MICRORUPTOR 6
          2
          Cleared 510(K)
        • K170500
          SIROLaser Advance+
          2
          Cleared 510(K)
        • K163638
          Dental 5 Multi Diode laser
          2
          Cleared 510(K)
        • K170734
          Venus Silk.expert
          2
          Cleared 510(K)
        • K170718
          Iridex TruFocus LIO Premiere
          2
          Cleared 510(K)
        • K162334
          U.S. Laser Worx Patriot 1 family of lasers
          2
          Cleared 510(K)
        • K170936
          Cutera enlighten III Laser System
          2
          Cleared 510(K)
        • K170215
          LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock
          2
          Cleared 510(K)
        • K170724
          NeuroBlate System
          2
          Cleared 510(K)
        • K160549
          MEDICAL DIODE LASER SYSTEMS
          2
          Cleared 510(K)
        • K161257
          MultiPulse HoPLUS
          2
          Cleared 510(K)
        • K162556
          LIGHTFUSION LED SYSTEM
          2
          Cleared 510(K)
        • K163103
          Tranberg CLS Diffusor Laser Fiber
          2
          Cleared 510(K)
        • K163655
          Sparkling
          2
          Cleared 510(K)
        • K170331
          Cyber Ho
          2
          Cleared 510(K)
        • K162837
          Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser System
          2
          Cleared 510(K)
        • K161926
          ND YAG Q-switch Laser Therapy Machine
          2
          Cleared 510(K)
        • K163123
          Q-Switched Nd:YAG Laser Therapy Systems
          2
          Cleared 510(K)
        • K162454
          PicoWay Laser System
          2
          Cleared 510(K)
        • K162851
          eLyx-PRO
          2
          Cleared 510(K)
        • K163128
          Epic Pro
          2
          Cleared 510(K)
        • K162765
          Venus Velocity Diode Laser System
          2
          Cleared 510(K)
        • K162114
          Photon, Photon Plus
          2
          Cleared 510(K)
        • K161632
          FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)
          2
          Cleared 510(K)
        • K163222
          Discovery Pico Family
          2
          Cleared 510(K)
        • K163009
          Litho
          2
          Cleared 510(K)
        • K162191
          NAVILAS Laser System
          2
          Cleared 510(K)
        • K162363
          V30 system, V-Form Handpiece BC Medium applicator
          2
          Cleared 510(K)
        • K162914
          VenaCure EVLT NeverTouch Procedure Kit
          2
          Cleared 510(K)
        • K161692
          Diode Laser Therapy Machine
          2
          Cleared 510(K)
        • K162781
          Magma Spark
          2
          Cleared 510(K)
        • K161670
          Lucid Q-PTP / HWA 55
          2
          Cleared 510(K)
        • K160488
          Cutera enlighten III Laser System
          2
          Cleared 510(K)
        • K160312
          FRAXIS DUO
          2
          Cleared 510(K)
        • K162169
          EdgeOne CO2 Laser
          2
          Cleared 510(K)
        • K162762
          NeuroBlate System
          2
          Cleared 510(K)
        • K161981
          Olive Plus
          2
          Cleared 510(K)
        • K161925
          CO2 Laser Therapy Machine
          2
          Cleared 510(K)
        • K162416
          IRIDEX Cyclo G6 Laser System, G-Probe Illuminate
          2
          Cleared 510(K)
        • K161185
          LUCERNA Dental Laser
          2
          Cleared 510(K)
        • K160413
          Sterling 5W Diode Laser
          2
          Cleared 510(K)
        • K161162
          Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
          2
          Cleared 510(K)
        • K161356
          Matrix LS-40 CO2 Laser System
          2
          Cleared 510(K)
        • K161503
          ORION
          2
          Cleared 510(K)
        • K161403
          A.R.C. Laser Surgical Fibers and Probes
          2
          Cleared 510(K)
        • K161771
          Medilas H Laser Fibers
          2
          Cleared 510(K)
        • K161669
          Waterlase Express
          2
          Cleared 510(K)
        • K153124
          DuraLazeTM HoLEP Laser Fiber
          2
          Cleared 510(K)
        • K160607
          PicoWay Laser System
          2
          Cleared 510(K)
        • K152737
          Lite Touch
          2
          Cleared 510(K)
        • K152667
          ATOVEN-Reusable Laser Fiber
          2
          Cleared 510(K)
        • K160012
          O-pel Laser and families of probe delivery devices
          2
          Cleared 510(K)
        • K152856
          Helios III
          2
          Cleared 510(K)
        • K160480
          PicoSure Workstation
          2
          Cleared 510(K)
        • K160952
          Alma Diode Tabletop Laser
          2
          Cleared 510(K)
        • K160227
          ACCENTO / HWA Dual/Single laser
          2
          Cleared 510(K)
        • K151855
          SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber
          2
          Cleared 510(K)
        • K153229
          Superbium
          2
          Cleared 510(K)
        • K153566
          Magma System
          2
          Cleared 510(K)
        • K160368
          EVO platform
          2
          Cleared 510(K)
        • K153564
          PURE CRYOGEN
          2
          Cleared 510(K)
        • K160513
          Quanta System Surgical Laser fibers
          2
          Cleared 510(K)
        • K151763
          PerioLase Nd:YAG Pulsed Dental Laser System
          2
          Cleared 510(K)
        • K153671
          Family of CoolGlide Aesthetic Lasers
          2
          Cleared 510(K)
        • K153527
          PicoWay Laser System
          2
          Cleared 510(K)
        • K160392
          Novilase Laser Therapy System, Model LTS-2
          2
          Cleared 510(K)
        • K152736
          SKIN CARE
          2
          Cleared 510(K)
        • K152611
          V20 system
          2
          Cleared 510(K)
        • K153718
          Spirit Hair Removal laser Family
          2
          Cleared 510(K)
        • K151569
          Tranberg CLS Laser Fiber
          2
          Cleared 510(K)
        • K152898
          DIODE LASER THERAPY SYSTEMS
          2
          Cleared 510(K)
        • K152529
          NaturaLase CO2 Laser System
          2
          Cleared 510(K)
        • K143713
          Lustre PRO Light System
          2
          Cleared 510(K)
        • K151890
          Medical Diode Laser Systems
          2
          Cleared 510(K)
        • K150997
          RUBY STAR
          2
          Cleared 510(K)
        • K150664
          NeoLas
          2
          Cleared 510(K)
        • K152714
          Quanta Forte
          2
          Cleared 510(K)
        • K152636
          Laser Dock
          2
          Cleared 510(K)
        • K152153
          MicroSpot Handpiece
          2
          Cleared 510(K)
        • K152722
          neoV980 & neoV1470 Diode Lasers
          2
          Cleared 510(K)
        • K152012
          EVO platform
          2
          Cleared 510(K)
        • K152417
          Adler MicroMed Laser Surgery Fibers
          2
          Cleared 510(K)
        • K152939
          Picasso Plus, Picasso Lite Plus
          2
          Cleared 510(K)
        • K151109
          Lumenis Smart532 Laser System
          2
          Cleared 510(K)
        • K151629
          Guardian 1000
          2
          Cleared 510(K)
        • K152591
          Medilas H RFID Laser Fibers
          2
          Cleared 510(K)
        • K151306
          Solea
          2
          Cleared 510(K)
        • K152032
          ELUMI 810 + 980 Soft Tissue Laser
          2
          Cleared 510(K)
        • K151655
          CO2RE System
          2
          Cleared 510(K)
        • K152220
          MH01
          2
          Cleared 510(K)
        • K151473
          NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module
          2
          Cleared 510(K)
        • K151947
          LightSheer Desire Light Laser System
          2
          Cleared 510(K)
        • K151232
          VIKINI Diode Laser System
          2
          Cleared 510(K)
        • K150587
          Cortex Laser System
          2
          Cleared 510(K)
        • K150907
          Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
          2
          Cleared 510(K)
        • K151331
          The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch
          2
          Cleared 510(K)
        • K150140
          MCL 31 Dermablate
          2
          Cleared 510(K)
        • K140386
          LUMINA 24
          2
          Cleared 510(K)
        • K143666
          Noblex Long Pulse Alexandrite Laser
          2
          Cleared 510(K)
        • K142216
          Tranberg CLS Thermal Therapy System
          2
          Cleared 510(K)
        • K142186
          DIODE LASER HAIR REMOVAL SYSTEM
          2
          Cleared 510(K)
        • K150326
          PicoWay Laser System
          2
          Cleared 510(K)
        • K150516
          DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS
          2
          Cleared 510(K)
        • K143723
          SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro
          2
          Cleared 510(K)
        • K150027
          CYMA
          2
          Cleared 510(K)
        • K133788
          COOK HOLMIUM LASER FIBER
          2
          Cleared 510(K)
        • K143519
          The MeDioStar NeXT Family
          2
          Cleared 510(K)
        • K141975
          WATERLASE IPLUS S
          2
          Cleared 510(K)
        • K150336
          Photonica Professional
          2
          Cleared 510(K)
        • K143105
          Picosure Workstation
          2
          Cleared 510(K)
        • K143457
          NeuroBlate System
          2
          Cleared 510(K)
        • K142924
          Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family
          2
          Cleared 510(K)
        • K141986
          ELUX 810 LASER
          2
          Cleared 510(K)
        • K133891
          MULTIPULSE TM+1470
          2
          Cleared 510(K)
        • K141511
          SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS
          2
          Cleared 510(K)
        • K142860
          Lumenis M22 System
          2
          Cleared 510(K)
        • K142952
          InMode Diolaze Device
          2
          Cleared 510(K)
        • K141852
          IFS ADVANCED FEMTOSECOND LASER SYSTEM
          2
          Cleared 510(K)
        • K143154
          IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID)
          2
          Cleared 510(K)
        • K141851
          NAVILAS LASER SYSTEM
          2
          Cleared 510(K)
        • K142638
          ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273)
          2
          Cleared 510(K)
        • K142093
          V20 SYSTEM
          2
          Cleared 510(K)
        • K140732
          CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
          2
          Cleared 510(K)
        • K141555
          ADVANTAGE
          2
          Cleared 510(K)
        • K140727
          CUTERA PICOSECOND LASER SYSTEM
          2
          Cleared 510(K)
        • K142286
          NS3000 Holmium Laser System
          2
          Cleared 510(K)
        • K142372
          Pico Way Laser System
          2
          Cleared 510(K)
        • K141908
          DUAL SWITCH
          2
          Cleared 510(K)
        • K141658
          LIGHT SCALPEL
          2
          Cleared 510(K)
        • K140470
          OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER
          2
          Cleared 510(K)
        • K131987
          MULTIPULSE HOPLUS
          2
          Cleared 510(K)
        • K142614
          AngioDynamics VenaCure EVLT Tre’ Sheath and VenaCure EVLT NeverTouch Procedure Kits
          2
          Cleared 510(K)
        • K140120
          EPIC 10
          2
          Cleared 510(K)
        • K140249
          LONG PULSE ND: YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K141973
          DIODE LASER HAIR REMOVAL SYSTEM
          2
          Cleared 510(K)
        • K140378
          FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT
          2
          Cleared 510(K)
        • K142376
          Palomar Icon Aesthetic System
          2
          Cleared 510(K)
        • K140837
          LUCID LY
          2
          Cleared 510(K)
        • K140719
          PICOSURE WORKSTATION
          2
          Cleared 510(K)
        • K142226
          Pilot Ultra Diode Laser
          2
          Cleared 510(K)
        • K142223
          Pilot Pro Diode Laser
          2
          Cleared 510(K)
        • K142225
          Pilot Elite Diode Laser
          2
          Cleared 510(K)
        • K141425
          ELITE + LASER SYSTEM
          2
          Cleared 510(K)
        • K133895
          DEKA SMARTXIDE LASER SYSTEM
          2
          Cleared 510(K)
        • K140964
          CALCULASE II
          2
          Cleared 510(K)
        • K140009
          SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM
          2
          Cleared 510(K)
        • K140458
          DIOTECH LASER FIBER
          2
          Cleared 510(K)
        • K140366
          ENDLESSFIBER REUSABLE SURGICAL LASER FIBER
          2
          Cleared 510(K)
        • K141983
          NEUROBLATE SYSTEM
          2
          Cleared 510(K)
        • K133945
          CUTERA PICOSECOND LASER SYSTEM
          2
          Cleared 510(K)
        • K141101
          LITHO
          2
          Cleared 510(K)
        • K141403
          LITHO DK30
          2
          Cleared 510(K)
        • K141838
          SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL)
          2
          Cleared 510(K)
        • K133364
          PICOSURE WORKSTATION
          2
          Cleared 510(K)
        • K140005
          ALMA DIODE TABLETOP LASER
          2
          Cleared 510(K)
        • K131757
          TATTOOSTAR EFFECT COMBO
          2
          Cleared 510(K)
        • K141063
          LINSCAN 808, LINSCAN 980
          2
          Cleared 510(K)
        • K132806
          FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE
          2
          Cleared 510(K)
        • K140679
          SUREFLEX LITHOTRIPSY LASER FIBERS
          2
          Cleared 510(K)
        • K133297
          QUADROSTARPROGREEN, QUADROSTARPROYELLOW
          2
          Cleared 510(K)
        • K133774
          ATOVEN
          2
          Cleared 510(K)
        • K140122
          CANDELA GENTLEMAX FAMILY OF LASER SYSTEM
          2
          Cleared 510(K)
        • K131838
          DIODE LASER FOR HIAR REMOVAL
          2
          Cleared 510(K)
        • K133915
          GALAXY CO2 LASER SYSTEM
          2
          Cleared 510(K)
        • K133006
          NEOV DIODE LASER FAMILY
          2
          Cleared 510(K)
        • K132976
          ADVATX
          2
          Cleared 510(K)
        • K140503
          FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER
          2
          Cleared 510(K)
        • K133837
          VIORA V-TOTAL
          2
          Cleared 510(K)
        • K132607
          NS 2500 HOLMIUM LASER SYSTEM
          2
          Cleared 510(K)
        • K133319
          ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060
          2
          Cleared 510(K)
        • K132975
          SPHINX JR
          2
          Cleared 510(K)
        • K140388
          LUMENIS PULSE 120H
          2
          Cleared 510(K)
        • K122358
          NOVEON
          2
          Cleared 510(K)
        • K133254
          REVLITE Q-SWITCHED ND:YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K133158
          ND: YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K132989
          SPEED 808 DIODE LASER SYSTEM
          2
          Cleared 510(K)
        • K132286
          HYPERION LONG PULSED ND: YAG LASER
          2
          Cleared 510(K)
        • K131837
          CO2 FRACTIONAL LASER
          2
          Cleared 510(K)
        • K131857
          Q-SWITCHED ND:YAG LASER
          2
          Cleared 510(K)
        • K130681
          ENDOVASCULAR LASER VENOUS SYSTEM KIT WITH 2 RING RADIAL EMITTING FIBER
          2
          Cleared 510(K)
        • K132661
          LIGHTSCALPEL
          2
          Cleared 510(K)
        • K133283
          CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS
          2
          Cleared 510(K)
        • K133561
          VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH
          2
          Cleared 510(K)
        • K132185
          FAMILY OF COOLGLIDE AESTHETIC LASERS
          2
          Cleared 510(K)
        • K131095
          DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS
          2
          Cleared 510(K)
        • K131142
          GENESIS LED WANDS
          2
          Cleared 510(K)
        • K130199
          CLARITY LPC LASER SYSTEM
          2
          Cleared 510(K)
        • K131839
          DC 7
          2
          Cleared 510(K)
        • K131894
          NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT
          2
          Cleared 510(K)
        • K131473
          (QUANTA SYSTEM) SURGICAL LASER FIBERS
          2
          Cleared 510(K)
        • K131059
          PIONEER ELITE DIODE LASER
          2
          Cleared 510(K)
        • K123443
          PRECISE SHP DIODE LASER
          2
          Cleared 510(K)
        • K131955
          NEUROBLATE(TM) SYSTEM
          2
          Cleared 510(K)
        • K131805
          INPULSE LASER
          2
          Cleared 510(K)
        • K130420
          SOLEA
          2
          Cleared 510(K)
        • K131278
          MONTERIS MEDICAL NEUROBLATE SYSTEM
          2
          Cleared 510(K)
        • K131081
          CYBER TM FAMILY
          2
          Cleared 510(K)
        • K130256
          MDK MULTI-APPLICATIONS PLATFORM
          2
          Cleared 510(K)
        • K124030
          COOK HOLMIUM LASER FIBER
          2
          Cleared 510(K)
        • K122567
          JOULE 810/940/980 MULTI-PLATFORM SYSTEM
          2
          Cleared 510(K)
        • K130193
          FRAXEL DUAL 1550/1927 LASER SYSTEM
          2
          Cleared 510(K)
        • K122020
          PHOTON PHOTON PLUS
          2
          Cleared 510(K)
        • K130444
          H-30 HOLMIUM LASER SYSTEM
          2
          Cleared 510(K)
        • K122493
          GENESISPLUS
          2
          Cleared 510(K)
        • K130250
          QYAG LASER SYSTEM
          2
          Cleared 510(K)
        • K122368
          WATERLASE IPLUS ALL TISSUE LASER
          2
          Cleared 510(K)
        • K123483
          DIODE LASER
          2
          Cleared 510(K)
        • K123573
          YOULASER CO2 LASER
          2
          Cleared 510(K)
        • K130465
          EPIC 10S
          2
          Cleared 510(K)
        • K123777
          MULTILASER SYSTEM
          2
          Cleared 510(K)
        • K123293
          PASTELLE Q-SWITCHED ND: YAG LASER
          2
          Cleared 510(K)
        • K120561
          NEUROBLATE SYSTEM
          2
          Cleared 510(K)
        • K130671
          VENACURE EVLT NEVERTOUCH PROCEDURE KIT
          2
          Cleared 510(K)
        • K130164
          FIBERLASE ENDURE CO2 FIBER
          2
          Cleared 510(K)
        • K130413
          PINPOINTE FOOTLASER
          2
          Cleared 510(K)
        • K130344
          DORNIER MEDILAS UROPULSE
          2
          Cleared 510(K)
        • K123682
          INMODE HAIR REMOVAL (HR) DEVICE
          2
          Cleared 510(K)
        • K110941
          REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200
          2
          Cleared 510(K)
        • K123494
          SOLEA
          2
          Cleared 510(K)
        • K122159
          DORNIER MEDILAS H30 SOLVO
          2
          Cleared 510(K)
        • K121327
          DIOLASE 10S
          2
          Cleared 510(K)
        • K113504
          DEKA SMARTXIDE AND DELIVERY ACCESSORIES
          2
          Cleared 510(K)
        • K122251
          VITRA MULTISPOT
          2
          Cleared 510(K)
        • K124003
          MED-FIBERS SURGICAL LASER FIBER, MED-FIBERS ENDO-ENT LASER PROBES, MED-FIBERS END- AND ASPIRATING LASER PROBES, MED-FIBE
          2
          Cleared 510(K)
        • K121570
          AURIGA QI
          2
          Cleared 510(K)
        • K123004
          MIRA LASERS
          2
          Cleared 510(K)
        • K122922
          E-BEAM ND: YAG LASER
          2
          Cleared 510(K)
        • K123168
          Q-PLUS T+ IPL LASER SYSTEM
          2
          Cleared 510(K)
        • K123385
          MEDILAS H LASER FIBERS
          2
          Cleared 510(K)
        • K123257
          EMVERA DIOLUX
          2
          Cleared 510(K)
        • K113018
          APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM
          2
          Cleared 510(K)
        • K120932
          OPELASER PRO II AND THE OPELASER LITE II
          2
          Cleared 510(K)
        • K123031
          BWF-5 MEDICAL LASER SERIES
          2
          Cleared 510(K)
        • K123037
          LIGHTSCALPEL
          2
          Cleared 510(K)
        • K121475
          TXCELL SCANNING LASER DELIVERY SYSTEM
          2
          Cleared 510(K)
        • K121346
          PICOSURE WORKSTATION
          2
          Cleared 510(K)
        • K120460
          SMARTLUX
          2
          Cleared 510(K)
        • K121286
          EPIC 10
          2
          Cleared 510(K)
        • K121580
          SURELASE CO2 LASER SYSTEM
          2
          Cleared 510(K)
        • K120235
          MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP
          2
          Cleared 510(K)
        • K120737
          TRIA LASER HAIR REMOVAL SYSTEM
          2
          Cleared 510(K)
        • K113472
          PRECISE SHP DIODE LASER
          2
          Cleared 510(K)
        • K121938
          MEDILAS H RFID LASER FIBER
          2
          Cleared 510(K)
        • K120926
          ENDOBEAM HOLMIUM LASER FIBERS
          2
          Cleared 510(K)
        • K113489
          ORION
          2
          Cleared 510(K)
        • K120377
          ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A
          2
          Cleared 510(K)
        • K121162
          POLARIS Q-SWITCH RUBY SYSTEM
          2
          Cleared 510(K)
        • K121471
          LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS
          2
          Cleared 510(K)
        • K120810
          FIBEROPTIC LASER DELIVERY SYSTEM
          2
          Cleared 510(K)
        • K121031
          WAVELIGHT FS200 PATIENT INTERFACE 1505
          2
          Cleared 510(K)
        • K120870
          GREENLIGHT MOXY FIBER OPTIC
          2
          Cleared 510(K)
        • K120573
          MEDART 620
          2
          Cleared 510(K)
        • K113868
          EPLUS SKIN TREATMENT SYSTEM
          2
          Cleared 510(K)
        • K120622
          PALOMAR VECTUS LASER
          2
          Cleared 510(K)
        • K121127
          SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS
          2
          Cleared 510(K)
        • K112669
          TATTOOSTAR EFFECT Y
          2
          Cleared 510(K)
        • K120437
          TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM
          2
          Cleared 510(K)
        • K120231
          EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL)
          2
          Cleared 510(K)
        • K112141
          SMARTEPIL,DEPILASE YAG LASE PLUS
          2
          Cleared 510(K)
        • K112505
          ETHEREA
          2
          Cleared 510(K)
        • K113502
          ADVANTAGE LASER SYSTEM
          2
          Cleared 510(K)
        • K113115
          EPICARE YAG
          2
          Cleared 510(K)
        • K113688
          MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM
          2
          Cleared 510(K)
        • K113151
          IFS LASER SYSTEM
          2
          Cleared 510(K)
        • K113588
          SPECTRA LASER SYSTEM
          2
          Cleared 510(K)
        • K111689
          STLASE
          2
          Cleared 510(K)
        • K113390
          LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500)
          2
          Cleared 510(K)
        • K112600
          ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT
          2
          Cleared 510(K)
        • K113858
          MEGABEAM ENDO-ENT PROBE
          2
          Cleared 510(K)
        • K113709
          MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE
          2
          Cleared 510(K)
        • K113792
          MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE
          2
          Cleared 510(K)
        • K112013
          EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER
          2
          Cleared 510(K)
        • K113140
          VARI-LASE WIREFIBER LASER FIBER
          2
          Cleared 510(K)
        • K111303
          DERMATOLOGICAL TREATMENT DEVICE FAMILY
          2
          Cleared 510(K)
        • K112987
          TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM
          2
          Cleared 510(K)
        • K110364
          DORNIER MEDILAS D LITEBEAM+ 1470
          2
          Cleared 510(K)
        • K113212
          DENTAL LASER THERAPY SYSTEM
          2
          Cleared 510(K)
        • K112299
          ENDOVASCULAR LASER VEIN SYSTEM KIT
          2
          Cleared 510(K)
        • K112166
          ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE
          2
          Cleared 510(K)
        • K112715
          CANDELA GENTLEMAX FAMILY OF LASERS
          2
          Cleared 510(K)
        • K112442
          RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
          2
          Cleared 510(K)
        • K111475
          AURIGA XL
          2
          Cleared 510(K)
        • K112253
          CERALAS 147NM DIODE LASER SYSTEM
          2
          Cleared 510(K)
        • K102359
          PICASSO/ PICASSO LITE/ PICASSO PERIO
          2
          Cleared 510(K)
        • K111360
          SHEAUMANN PL-980
          2
          Cleared 510(K)
        • K112031
          ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION
          2
          Cleared 510(K)
        • K111359
          SHEAUMANN PL-1064
          2
          Cleared 510(K)
        • K112324
          CERALAS 980NM DIODE LASER FAMILY
          2
          Cleared 510(K)
        • K111592
          YOULASER CO2 LASER SYSTEM
          2
          Cleared 510(K)
        • K111213
          VISION ONE LASER SYSTEM
          2
          Cleared 510(K)
        • K111144
          CANDELA GENTLELASE FAMILY OF LASERS
          2
          Cleared 510(K)
        • K111851
          MEDIOSTAR NEXT
          2
          Cleared 510(K)
        • K110897
          CORTEX CO2 / ER:YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K101306
          SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A
          2
          Cleared 510(K)
        • K110243
          MEDART DIODE LASER SYSTEM & ACCESSORIES
          2
          Cleared 510(K)
        • K110907
          PALOMAR ICON (TM) AESTHETIC SYSTEM
          2
          Cleared 510(K)
        • K102954
          CUTERA QSWITCH LASER SYSTEM
          2
          Cleared 510(K)
        • K110225
          ANGIODYNAMICS, INC. VENACURE 1470 LASER
          2
          Cleared 510(K)
        • K103455
          SPECTRA LASER SYSTEM
          2
          Cleared 510(K)
        • K110502
          TRIPLEX ER. YAG / ND: YAG SYSTEM
          2
          Cleared 510(K)
        • K110434
          TRIXEL CO2 LASER
          2
          Cleared 510(K)
        • K110304
          APEX ER. YAG / IPL SYSTEM
          2
          Cleared 510(K)
        • K103654
          VELA XL
          2
          Cleared 510(K)
        • K110685
          FLEXIVA TRACTIP
          2
          Cleared 510(K)
        • K110686
          ACCUTRAC
          2
          Cleared 510(K)
        • K101916
          JOULE MULTI-PLATFORM SYSTEM
          2
          Cleared 510(K)
        • K110080
          RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
          2
          Cleared 510(K)
        • K103753
          SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER
          2
          Cleared 510(K)
        • K110079
          SPPHINE PLUS STM 3W DIODE LASER
          2
          Cleared 510(K)
        • K103288
          DEKA SYNCHRO FT
          2
          Cleared 510(K)
        • K103539
          QUANTA SYSTEM DUOLITE
          2
          Cleared 510(K)
        • K103501
          ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES
          2
          Cleared 510(K)
        • K101904
          SMARTXIDE 50 HS/MS
          2
          Cleared 510(K)
        • K103667
          SAPPHIRE ST PORTABLE DIODE LASER
          2
          Cleared 510(K)
        • K102755
          CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER
          2
          Cleared 510(K)
        • K102796
          ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT
          2
          Cleared 510(K)
        • K102749
          QUANTA CYBER TM 150W
          2
          Cleared 510(K)
        • K102639
          SL3
          2
          Cleared 510(K)
        • K100199
          ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND VENACUREEVLT PROCEDURE KIT
          2
          Cleared 510(K)
        • K101817
          LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N
          2
          Cleared 510(K)
        • K103118
          REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR
          2
          Cleared 510(K)
        • K102669
          DIODE LASER THERAPY SYSTEM
          2
          Cleared 510(K)
        • K101321
          EMATRIX CO2
          2
          Cleared 510(K)
        • K101712
          ENDOVASCULAR LAER VEIN SYSTEM KIT
          2
          Cleared 510(K)
        • K101006
          WAVELIGHT FS200 LASER SYSTEM MODEL: FS200
          2
          Cleared 510(K)
        • K093545
          PINPOINTE FOOTLASER MODEL 6W, 30W, 100W
          2
          Cleared 510(K)
        • K102716
          MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS
          2
          Cleared 510(K)
        • K102036
          DOCTOR SURGERY DIODE LASERS FAMILY
          2
          Cleared 510(K)
        • K101601
          AFFIRM DO DIODE LASER
          2
          Cleared 510(K)
        • K101573
          ACCUSCULPT II LASER SYSTEM
          2
          Cleared 510(K)
        • K092734
          E-LIGHT LINE
          2
          Cleared 510(K)
        • K101555
          CO2 LASER SYSTEM
          2
          Cleared 510(K)
        • K100726
          CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM
          2
          Cleared 510(K)
        • K101783
          COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE
          2
          Cleared 510(K)
        • K094049
          STLASE DIODE LASER
          2
          Cleared 510(K)
        • K101152
          NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810
          2
          Cleared 510(K)
        • K100143
          PILOT DIODE LASER, MODEL 002-00139
          2
          Cleared 510(K)
        • K100098
          PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE
          2
          Cleared 510(K)
        • K101658
          WATERLASE MD TURBO PLUS MODEL 7200XXX
          2
          Cleared 510(K)
        • K102050
          Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6
          2
          Cleared 510(K)
        • K100558
          QUANTA DIODE LASER SYSTEM
          2
          Cleared 510(K)
        • K100678
          SUPRA SCAN DELIVERY SYSTEM
          2
          Cleared 510(K)
        • K092860
          LASEMAR 800, 1000, 1500
          2
          Cleared 510(K)
        • K101415
          THERACLEAR
          2
          Cleared 510(K)
        • K100893
          CHEVEUX DIODE LASER SYSTEM
          2
          Cleared 510(K)
        • K100746
          FIBER ONE
          2
          Cleared 510(K)
        • K100194
          OPTICAL INTEGRITY LASERGUARD FIBERS
          2
          Cleared 510(K)
        • K093087
          BWF-5 MEDICAL LASER SERIES
          2
          Cleared 510(K)
        • K100415
          ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM
          2
          Cleared 510(K)
        • K100384
          FIBERLASE C02 LASER WAVEGUIDE
          2
          Cleared 510(K)
        • K100270
          ARTISAN AESTHETIC SYSTEM
          2
          Cleared 510(K)
        • K093048
          D-STORM 810NM, D-STORM 980NM
          2
          Cleared 510(K)
        • K100035
          MODEL VISULAS 532S LASER WITH THE VITE OPTION
          2
          Cleared 510(K)
        • K100474
          QUICKLASEDUAL+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 MODEL: 3W,5W,3W,5W
          2
          Cleared 510(K)
        • K093852
          EZLASE 3 LASER SYSTEM
          2
          Cleared 510(K)
        • K100228
          VERSAPULSE MODEL P20 LASER SYSTEM
          2
          Cleared 510(K)
        • K093793
          LS-40 CO2 LASER SYSTEM MODEL LS-40
          2
          Cleared 510(K)
        • K100078
          MODIFIED STRAIGHT FIRE LASER FIBER
          2
          Cleared 510(K)
        • K082230
          VECTRA PLUS LASER SYSTEM AND ACCESSORIES
          2
          Cleared 510(K)
        • K093162
          FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID
          2
          Cleared 510(K)
        • K093502
          VARI-LASE ENDOVENOUS LASER CONSOLE
          2
          Cleared 510(K)
        • K090312
          TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC
          2
          Cleared 510(K)
        • K082586
          LIGHTWAVE PROFESSIONAL DELUXE
          2
          Cleared 510(K)
        • K090820
          TRIA HAIR REMOVAL LASER SYSTEM
          2
          Cleared 510(K)
        • K093691
          ACCUMAX
          2
          Cleared 510(K)
        • K092964
          COOLTOUCH VARIA ND:YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K091746
          WATERLASE MD, MODEL 7100102
          2
          Cleared 510(K)
        • K092660
          SIROLASER ADVANCE
          2
          Cleared 510(K)
        • K083123
          MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES
          2
          Cleared 510(K)
        • K093451
          OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP
          2
          Cleared 510(K)
        • K090195
          PALOMAR LUX1540 HANDPIECE
          2
          Cleared 510(K)
        • K092735
          GREENLIGHT XPS LASER SYSTEM
          2
          Cleared 510(K)
        • K091625
          EPICARE-DUO LASER SYSTEM
          2
          Cleared 510(K)
        • K091115
          ECO2 LASER SYSTEM
          2
          Cleared 510(K)
        • K093251
          OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM
          2
          Cleared 510(K)
        • K092197
          PHOTEX30 DIODE LASER SERIES: 980, 810, 940
          2
          Cleared 510(K)
        • K083927
          WATERLASE MD
          2
          Cleared 510(K)
        • K091800
          LIPOEZE LASER ASSISTED ASPIRATION CANNULA
          2
          Cleared 510(K)
        • K091562
          DOCTOR SMILE A-810 AND B-980 LASERS
          2
          Cleared 510(K)
        • K091537
          CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTH
          2
          Cleared 510(K)
        • K090762
          LEDA
          2
          Cleared 510(K)
        • K091320
          SPECTRA SP II, SPECTRA DENTA II
          2
          Cleared 510(K)
        • K091059
          FOXQ 980 LASER
          2
          Cleared 510(K)
        • K090571
          ALMA LASERS ALEX755 MODULE
          2
          Cleared 510(K)
        • K091796
          SOFTLASE PRO, ORTHOLASE AND HYGIENELASE
          2
          Cleared 510(K)
        • K091666
          PASCAL PHOTOCOAGULATOR, PASCAL-US
          2
          Cleared 510(K)
        • K091922
          WATERLASE C100, MODEL 7100104
          2
          Cleared 510(K)
        • K091909
          LITHO LASER SYSTEM
          2
          Cleared 510(K)
        • K090126
          FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2,
          2
          Cleared 510(K)
        • K090164
          CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER
          2
          Cleared 510(K)
        • K091551
          VARI-LASE PLATINUM BRIGHT TIP LASER FIBER
          2
          Cleared 510(K)
        • K090962
          CYBER SURGICAL LASER FAMILY INCLUDING: CYBER TM, CYBER GREEN, CYBER GREEN TM
          2
          Cleared 510(K)
        • K083616
          PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS
          2
          Cleared 510(K)
        • K091323
          MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200)
          2
          Cleared 510(K)
        • K090776
          MEGAPULSE LASER SYSTEM AND FIBERS
          2
          Cleared 510(K)
        • K083899
          REVLITE Q-SWITCHED ND:YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K090094
          ZELTIQ SYSTEM
          2
          Cleared 510(K)
        • K083253
          LOTUS II PULSED ER: YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K091169
          ELITE MPX LASER SYSTEM WITH CRYO C
          2
          Cleared 510(K)
        • K083733
          LUME 2 SYSTEM, MODEL GA0005000
          2
          Cleared 510(K)
        • K081509
          MONTERIS MEDICAL AUTOLITT LASER PROBE
          2
          Cleared 510(K)
        • K083203
          HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K083889
          FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY
          2
          Cleared 510(K)
        • K090618
          CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C
          2
          Cleared 510(K)
        • K090297
          BLUESHINE GOLD SERIES
          2
          Cleared 510(K)
        • K083848
          ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM
          2
          Cleared 510(K)
        • K083215
          INCISIVE FAMILY OF INPULSE ND:YAG LASERS
          2
          Cleared 510(K)
        • K090410
          COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY
          2
          Cleared 510(K)
        • K082039
          SYNCHRO HP PLATFORM
          2
          Cleared 510(K)
        • K081424
          AFFIRM CO2 AND AFFIRM CO2 HP
          2
          Cleared 510(K)
        • K090235
          ELITE MPX LASER SYSTEM WITH XPL HANDPIECE
          2
          Cleared 510(K)
        • K083478
          SMOOTHLIPO
          2
          Cleared 510(K)
        • K083142
          PICASSO LASER SYSTEM
          2
          Cleared 510(K)
        • K090084
          ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE
          2
          Cleared 510(K)
        • K090281
          ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES
          2
          Cleared 510(K)
        • K083900
          ERBIUM FRACTIONAL HANDPIECE
          2
          Cleared 510(K)
        • K081541
          DERMABLATE EFFECT
          2
          Cleared 510(K)
        • K083165
          PALOMAR ASPIRE LASER PLATFORM
          2
          Cleared 510(K)
        • K083500
          MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE
          2
          Cleared 510(K)
        • K090181
          WATERLASE MD
          2
          Cleared 510(K)
        • K082825
          ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM
          2
          Cleared 510(K)
        • K083034
          FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F
          2
          Cleared 510(K)
        • K082407
          MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K083918
          ATL CO2 MEDICAL LASER SYSTEMS, MODELS ATL-150 AND ATL-250
          2
          Cleared 510(K)
        • K083748
          IPULSE, MODEL: I150
          2
          Cleared 510(K)
        • K083258
          MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE
          2
          Cleared 510(K)
        • K083915
          ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC
          2
          Cleared 510(K)
        • K083795
          CYNOSURE SMARTLIPO MPX LASER
          2
          Cleared 510(K)
        • K082409
          SOLAR LASER ABLATION SYSTEM, MODELS: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000, LG-2001, LK-001, PM-1083, TF-1083
          2
          Cleared 510(K)
        • K083082
          MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS
          2
          Cleared 510(K)
        • K083730
          ISOLAZ
          2
          Cleared 510(K)
        • K083682
          180W CERELAS D 980NM DIODE LASER, MODEL D180
          2
          Cleared 510(K)
        • K083613
          QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY
          2
          Cleared 510(K)
        • K083476
          NOVEON MODEL LS1100-03
          2
          Cleared 510(K)
        • K082938
          EZLASE
          2
          Cleared 510(K)
        • K082911
          SMOOTHCOOL HR SYSTEM
          2
          Cleared 510(K)
        • K082809
          ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM
          2
          Cleared 510(K)
        • K083272
          SKINCLEAR Q-SWITCHED ND:YAG LASER
          2
          Cleared 510(K)
        • K083379
          CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE
          2
          Cleared 510(K)
        • K081095
          PROLITE III TOWER AND PR AND HR HANDPIECE
          2
          Cleared 510(K)
        • K082423
          NO!NO! SKIN
          2
          Cleared 510(K)
        • K082225
          15W CERALAS D 1470NM DIODE LASER, MODEL D1470
          2
          Cleared 510(K)
        • K083207
          ULTRAWAVE III EX 1320
          2
          Cleared 510(K)
        • K080591
          TANDA SKINCARE SYSTEM, MODEL: PTSCS
          2
          Cleared 510(K)
        • K083069
          EZLASE 10W
          2
          Cleared 510(K)
        • K082876
          BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY
          2
          Cleared 510(K)
        • K082101
          LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE
          2
          Cleared 510(K)
        • K082721
          LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS
          2
          Cleared 510(K)
        • K082263
          CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980
          2
          Cleared 510(K)
        • K082298
          FLASH N' GO
          2
          Cleared 510(K)
        • K081352
          PROFILE MULTI-PLATFORM SYSTEM
          2
          Cleared 510(K)
        • K081408
          ELLIPSE MULTIFLEX
          2
          Cleared 510(K)
        • K082928
          STRAIGHT FIRE HOLMIUM LASER FIBER
          2
          Cleared 510(K)
        • K082445
          CURATIVE980 DIODE LASER
          2
          Cleared 510(K)
        • K082232
          EVIS MD PLANTIUM BLUE
          2
          Cleared 510(K)
        • K082247
          EVIS MD PLATINUM RED LIGHT THERAPY
          2
          Cleared 510(K)
        • K082096
          POWERLIPO LASER SYSTEM
          2
          Cleared 510(K)
        • K073022
          CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830
          2
          Cleared 510(K)
        • K073000
          LUMAPROBE
          2
          Cleared 510(K)
        • K082004
          SMOOTHKIT+
          2
          Cleared 510(K)
        • K080382
          SELLAS
          2
          Cleared 510(K)
        • K080638
          CLARO
          2
          Cleared 510(K)
        • K073572
          MATRIX RF APPLICATOR
          2
          Cleared 510(K)
        • K081704
          SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS
          2
          Cleared 510(K)
        • K081744
          PASCAL SYNTHESIS DELIVERY SYSTEM
          2
          Cleared 510(K)
        • K073317
          STARLIGHT, MODEL PD9012
          2
          Cleared 510(K)
        • K081652
          CLAROS NANO DENTAL LASER SYSTEM
          2
          Cleared 510(K)
        • K073158
          SCULPTURE 2.94 ER:YAG SYSTEM
          2
          Cleared 510(K)
        • K073427
          MEDILAS D FAMILY LASERS
          2
          Cleared 510(K)
        • K080530
          MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE
          2
          Cleared 510(K)
        • K081939
          OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY
          2
          Cleared 510(K)
        • K082028
          LASERPEEL SOFT-MET MODIFIED ERBIUM LASER
          2
          Cleared 510(K)
        • K081457
          ATRILAZE LASER ABLATION SYSTEM
          2
          Cleared 510(K)
        • K071687
          FAMILI OF IRIDEX IQ LASER SYSTEMS
          2
          Cleared 510(K)
        • K082033
          NANNOLIGHT INTENSE PULSED LIGHT SYSTEM
          2
          Cleared 510(K)
        • K080463
          ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES
          2
          Cleared 510(K)
        • K081619
          CHROMOLITE EP
          2
          Cleared 510(K)
        • K080731
          PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE
          2
          Cleared 510(K)
        • K080975
          FENCER 308 EXCIMER LASER SYSTEM
          2
          Cleared 510(K)
        • K073074
          KEY LASER III 1243 US WITH DETECT
          2
          Cleared 510(K)
        • K081015
          CERALAS D 980NM DIODE LASER, MODELS D15 AND D25
          2
          Cleared 510(K)
        • K080496
          MOSAIC ECO2 LASER SYSTEM
          2
          Cleared 510(K)
        • K080915
          FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES
          2
          Cleared 510(K)
        • K081219
          APOLLO MINI IPL SYSTEM
          2
          Cleared 510(K)
        • K080959
          DORNIER MEDILAS D 30 LASER, MEDILAS D 1064
          2
          Cleared 510(K)
        • K072182
          ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060
          2
          Cleared 510(K)
        • K081612
          AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS
          2
          Cleared 510(K)
        • K081628
          MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO
          2
          Cleared 510(K)
        • K081578
          ACCELA SYSTEM
          2
          Cleared 510(K)
        • K080244
          PALOMAR LUX 1540 HANDPIECE
          2
          Cleared 510(K)
        • K081324
          CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS
          2
          Cleared 510(K)
        • K081589
          WATERLASE, VERSION 3.0
          2
          Cleared 510(K)
        • K080932
          MOSAIC LASER SYSTEM
          2
          Cleared 510(K)
        • K081416
          PALOMAR ASPIRE LASER PLATFORM
          2
          Cleared 510(K)
        • K072564
          ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM
          2
          Cleared 510(K)
        • K080374
          BIOSYAG MEDICAL SYSTEM
          2
          Cleared 510(K)
        • K081214
          STYLA MICROLASER AND STYLAORTHO
          2
          Cleared 510(K)
        • K073411
          LITEDUO
          2
          Cleared 510(K)
        • K073477
          PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS
          2
          Cleared 510(K)
        • K081181
          SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER
          2
          Cleared 510(K)
        • K080118
          ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE
          2
          Cleared 510(K)
        • K073404
          IFS LASER SYSTEM
          2
          Cleared 510(K)
        • K080248
          SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECES
          2
          Cleared 510(K)
        • K073715
          ELIPO
          2
          Cleared 510(K)
        • K072682
          50W CERALAS D 1950NM DIODE LASER
          2
          Cleared 510(K)
        • K080525
          COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W
          2
          Cleared 510(K)
        • K080567
          PALOMAR ASPIRE LASER PLATFORM
          2
          Cleared 510(K)
        • K080163
          COOLTOUCH MODELS LC215 AND COOLLIPO
          2
          Cleared 510(K)
        • K073617
          PHARAON LIPO
          2
          Cleared 510(K)
        • K080697
          SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER
          2
          Cleared 510(K)
        • K080735
          CRYOMINI
          2
          Cleared 510(K)
        • K073534
          CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS
          2
          Cleared 510(K)
        • K080104
          VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7542
          2
          Cleared 510(K)
        • K073583
          MODIFICATION TO PALOMAR LUX1540 HANDPIECE
          2
          Cleared 510(K)
        • K080406
          IPULSE, MODEL I400
          2
          Cleared 510(K)
        • K073659
          XTRAC ULTRA 2, MODEL AL10000
          2
          Cleared 510(K)
        • K070355
          FOTONA FIDELIS III ER:YAG/ND:YAG LASER SYSTEM FAMILY
          2
          Cleared 510(K)
        • K080006
          AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE
          2
          Cleared 510(K)
        • K073549
          Q-PLUS T
          2
          Cleared 510(K)
        • K073048
          PETERIO UNIVERSAL LASER SCANNING HANDPIECE
          2
          Cleared 510(K)
        • K073063
          15W CERALAS D 1470NM DIODE LASER
          2
          Cleared 510(K)
        • K073322
          FOX 1-980, FOX Q-1064, FOX-Q-810
          2
          Cleared 510(K)
        • K071896
          FOX 940, MODEL 940
          2
          Cleared 510(K)
        • K073332
          V-RASER DIODE LASER SYSTEM
          2
          Cleared 510(K)
        • K071363
          WATERLASE AND WATERLASE MD
          2
          Cleared 510(K)
        • K053527
          SPECTRA HAIR REMOVAL LASER
          2
          Cleared 510(K)
        • K080121
          CYNOSURE SMARTLIPO MULTIWAVLENGTH LASER
          2
          Cleared 510(K)
        • K071734
          WATERLASE MD DERM
          2
          Cleared 510(K)
        • K072833
          P-NAIN SYSTEM
          2
          Cleared 510(K)
        • K072779
          CERALAS D 980NM DIODE LASER, MODELS D15 AND D25
          2
          Cleared 510(K)
        • K073496
          OPTILITE HOLMIUM LASER FIBERS
          2
          Cleared 510(K)
        • K073464
          ANGIODYNAMICS, INC., NEVERTOUCH II 400UM FIBER AND VENACURE PROCEDURE KIT
          2
          Cleared 510(K)
        • K072906
          SILK'N
          2
          Cleared 510(K)
        • K071883
          IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4 SERIES 2
          2
          Cleared 510(K)
        • K072925
          CANDELA-INOLASE SERENITY PRO PSF SYSTEM
          2
          Cleared 510(K)
        • K072332
          VARI-LASE WIRE FIBER
          2
          Cleared 510(K)
        • K072331
          RADIANCY MISTRAL DEVICE
          2
          Cleared 510(K)
        • K073313
          MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP
          2
          Cleared 510(K)
        • K072751
          COOLTOUCH MODELS NS 160 AND LC215 COOLIPO
          2
          Cleared 510(K)
        • K073436
          SPECTRA VRMII 1-SWITCHED ND:YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K072484
          CYNOSURE YAG FAMILY LASER
          2
          Cleared 510(K)
        • K072159
          SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER
          2
          Cleared 510(K)
        • K072995
          TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER
          2
          Cleared 510(K)
        • K073409
          OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM
          2
          Cleared 510(K)
        • K073394
          SMARTLIPO LASER
          2
          Cleared 510(K)
        • K073300
          MILESMAN PREMIUM
          2
          Cleared 510(K)
        • K072344
          APL MEDICAL SYSTEM
          2
          Cleared 510(K)
        • K071815
          NOVEON, MODEL LS1100-01-0968
          2
          Cleared 510(K)
        • K072868
          ACCOLADE II LASER
          2
          Cleared 510(K)
        • K071768
          ERBIUM FRACTIONAL HANDPIECE
          2
          Cleared 510(K)
        • K071051
          FRAXEL III SR LASER SYSTEM AND ACCESSORIES
          2
          Cleared 510(K)
        • K072262
          GENTLERAY 980 DIODE LASER SYSTEM
          2
          Cleared 510(K)
        • K072767
          QUASAR BLUE LIGHT THERAPY SYSTEM
          2
          Cleared 510(K)
        • K070870
          SKIN CARE LIGHT
          2
          Cleared 510(K)
        • K071621
          RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES
          2
          Cleared 510(K)
        • K072424
          COOLTOUCH, MODEL LC215,COOLLIPO
          2
          Cleared 510(K)
        • K070296
          VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K072514
          VISULAS TRION
          2
          Cleared 510(K)
        • K072034
          DIODE MEDICAL LASER FAMILY, MODELS 4, 6, 30
          2
          Cleared 510(K)
        • K072023
          ELLIPSE JUVIA, MODEL 9EJU7465
          2
          Cleared 510(K)
        • K071328
          VISUALASE THERMAL THERAPY SYSTEM
          2
          Cleared 510(K)
        • K072106
          150W CERALAS D 980NM DIODE LASER
          2
          Cleared 510(K)
        • K070185
          TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001
          2
          Cleared 510(K)
        • K071469
          INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM
          2
          Cleared 510(K)
        • K071943
          SERENITY PRO PSF SYSTEM
          2
          Cleared 510(K)
        • K071959
          ANGIODYNAMICS, INC.NEVERTOUCH 600UM FIBER AND VENACURE PROCEDURE KIT
          2
          Cleared 510(K)
        • K071451
          TATTOOSTAR Y
          2
          Cleared 510(K)
        • K063427
          LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM
          2
          Cleared 510(K)
        • K070392
          MOSAIC LASER SYSTEM
          2
          Cleared 510(K)
        • K070805
          ULTRAWAVE II EX 1320
          2
          Cleared 510(K)
        • K070298
          MODIFICATION TO PALOMAR LUXIR HANDPIECE
          2
          Cleared 510(K)
        • K070924
          FLEXGUARD
          2
          Cleared 510(K)
        • K071152
          PALOMAR ERBIUM HANDPIECE
          2
          Cleared 510(K)
        • K070536
          MEDILAS D FAMILY LASERS
          2
          Cleared 510(K)
        • K070284
          FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM)
          2
          Cleared 510(K)
        • K071295
          100W CERALAS D 980NM DIODE LASER
          2
          Cleared 510(K)
        • K063104
          FOX MEDICAL DIODE LASER SYSTEM 810NM
          2
          Cleared 510(K)
        • K070388
          PROFILE MULTI-PLATFORM SYSTEM
          2
          Cleared 510(K)
        • K070353
          KELSEY INTERSITITAL LASER THERAPY SYSTEM
          2
          Cleared 510(K)
        • K070494
          EPI-C PLUS
          2
          Cleared 510(K)
        • K063808
          FRAXEL IV SR LASER SYSTEM
          2
          Cleared 510(K)
        • K063038
          FRAXEL III SR LASER SYSTEM AND ACCESSORIES
          2
          Cleared 510(K)
        • K070466
          REVOLIX DUO LASER SYSTEM
          2
          Cleared 510(K)
        • K062963
          PHAROS EXCIMER LASER SYSTEM, MODEL EX-308
          2
          Cleared 510(K)
        • K070138
          CUTERA ER:YAG LASER HANDPIECE
          2
          Cleared 510(K)
        • K063867
          CUTERA ER:YSGG LASER HANDPIECE
          2
          Cleared 510(K)
        • K070476
          REVOLIX 120
          2
          Cleared 510(K)
        • K062258
          GENESIS DIODE LASER
          2
          Cleared 510(K)
        • K070216
          VARI-LASE BRIGHT TIP FIBER
          2
          Cleared 510(K)
        • K063384
          DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980
          2
          Cleared 510(K)
        • K061489
          ATRILAZE MI SURGICAL ABLATION SYSTEM
          2
          Cleared 510(K)
        • K070378
          ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT
          2
          Cleared 510(K)
        • K063152
          CLAROS DENTAL LASER SYSTEM
          2
          Cleared 510(K)
        • K063001
          SLIM EVOLUTION FAMILY OF CO2 LASERS AND DELIVERY DEVICE ACCESSORIES
          2
          Cleared 510(K)
        • K063698
          CO2 LASER SYSTEM, MODEL C-LAS
          2
          Cleared 510(K)
        • K062762
          DERMA YAG
          2
          Cleared 510(K)
        • K061652
          PALOMAR LUX1540 HANDPIECE
          2
          Cleared 510(K)
        • K063682
          INTRALASE FUSION LASER
          2
          Cleared 510(K)
        • K063571
          PALOMAR LUX2940 HANDPIECE
          2
          Cleared 510(K)
        • K063800
          CANDELA FLUORESCENT PULSED LIGHT SYSTEM
          2
          Cleared 510(K)
        • K063715
          JUNIPER COOLING DEVICE XTRA
          2
          Cleared 510(K)
        • K070157
          OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER
          2
          Cleared 510(K)
        • K062303
          FRAXEL II SR LASER SYSTEM
          2
          Cleared 510(K)
        • K061720
          COSMELIGHT
          2
          Cleared 510(K)
        • K070063
          YAG MIR II LASER
          2
          Cleared 510(K)
        • K061898
          EZLASE
          2
          Cleared 510(K)
        • K070071
          OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER
          2
          Cleared 510(K)
        • K063828
          DIOMED DELTA 25
          2
          Cleared 510(K)
        • K063834
          REVLITE C6 Q-SWITCHED ND:YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K063396
          VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES
          2
          Cleared 510(K)
        • K063249
          BEAMAX
          2
          Cleared 510(K)
        • K062363
          BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM
          2
          Cleared 510(K)
        • K063074
          CANDELA 3630 LASER SYSTEM
          2
          Cleared 510(K)
        • K062314
          HORUS LASER KERATOME
          2
          Cleared 510(K)
        • K063072
          CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND 1064 ND:YAG HANDPIECE ACCESSORIES
          2
          Cleared 510(K)
        • K063073
          CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS
          2
          Cleared 510(K)
        • K061656
          LASER-D68
          2
          Cleared 510(K)
        • K061436
          PALOMAR Q-YAG 5 ND:YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K063112
          REVLITE Q-SWITCHED ND:YAG LASER
          2
          Cleared 510(K)
        • K062719
          GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES
          2
          Cleared 510(K)
        • K062589
          SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM
          2
          Cleared 510(K)
        • K063141
          OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER
          2
          Cleared 510(K)
        • K063060
          BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP
          2
          Cleared 510(K)
        • K062822
          VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7500
          2
          Cleared 510(K)
        • K062721
          GREENTON ECOLITE IPL SYSTEM
          2
          Cleared 510(K)
        • K062871
          LUMACARE LC-122M NON-COHERENT LIGHT SOURCE
          2
          Cleared 510(K)
        • K062619
          DENLASER 800 PLUS
          2
          Cleared 510(K)
        • K062369
          IRIDEX OCULIGHT TX
          2
          Cleared 510(K)
        • K062321
          SMARTLIPO ND:YAG LASER
          2
          Cleared 510(K)
        • K060653
          THERMACLEAR
          2
          Cleared 510(K)
        • K062336
          OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE
          2
          Cleared 510(K)
        • K062312
          AXIOM PULSED LIGHT SYSTEM
          2
          Cleared 510(K)
        • K061850
          MINI-YAG LASER
          2
          Cleared 510(K)
        • K062071
          PROMETEY, MODEL G1-03
          2
          Cleared 510(K)
        • K061966
          LITETOUCH DENTAL LASER SYSTEM
          2
          Cleared 510(K)
        • K060787
          TATTOOSTAR FAMILY
          2
          Cleared 510(K)
        • K062210
          COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160
          2
          Cleared 510(K)
        • K061618
          COOLTOUCH, MODEL CTEV
          2
          Cleared 510(K)
        • K062423
          OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM
          2
          Cleared 510(K)
        • K062048
          AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM
          2
          Cleared 510(K)
        • K053540
          INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE
          2
          Cleared 510(K)
        • K062248
          AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM
          2
          Cleared 510(K)
        • K060372
          INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3
          2
          Cleared 510(K)
        • K061455
          DORNIER MEDILAS H 20 LASER
          2
          Cleared 510(K)
        • K060966
          COOLTOUCH VARIA ND:YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K061470
          DEL SOL BLUE LIGHT THERAPY SYSTEM
          2
          Cleared 510(K)
        • K061909
          HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00
          2
          Cleared 510(K)
        • K061366
          DENLASER 800 PLUS
          2
          Cleared 510(K)
        • K060448
          LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE.
          2
          Cleared 510(K)
        • K052354
          OCULASE MD
          2
          Cleared 510(K)
        • K061117
          NANOLITE SKIN CARE SYSTEM
          2
          Cleared 510(K)
        • K061178
          ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT
          2
          Cleared 510(K)
        • K060905
          IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1
          2
          Cleared 510(K)
        • K060407
          JUNIPER COOLING DEVICE
          2
          Cleared 510(K)
        • K060752
          ACMI DUR-HL LASER SYSTEMS
          2
          Cleared 510(K)
        • K060977
          MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523
          2
          Cleared 510(K)
        • K051442
          PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT
          2
          Cleared 510(K)
        • K060516
          ELLIPSE 12PL, MODEL 9ESL7228
          2
          Cleared 510(K)
        • K052371
          DEPILITE EL-8B SERIES DERMO FLASH SYSTEMS
          2
          Cleared 510(K)
        • K060567
          SPECTRAGENICS ATS-1
          2
          Cleared 510(K)
        • K060680
          ATRILAZE SURGICAL ABLATION SYSTEM
          2
          Cleared 510(K)
        • K060114
          VECTRA LASER SYSTEM
          2
          Cleared 510(K)
        • K053628
          LIGHTSHEER DUET LASER SYSTEM
          2
          Cleared 510(K)
        • K060326
          LASERTX - DIODE LASER & DELIVERY SYSTEM
          2
          Cleared 510(K)
        • K060310
          FRAXEL II SR LASER SYSTEM AND ACCESSORIES
          2
          Cleared 510(K)
        • K060301
          PALOMAR LUX1540 HANDPIECE
          2
          Cleared 510(K)
        • K060411
          RADIANCY CLEARTOUCH LITE ACNE CLEARANCE SYSTEM
          2
          Cleared 510(K)
        • K060304
          PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940
          2
          Cleared 510(K)
        • K060459
          QUADROSTAR 980
          2
          Cleared 510(K)
        • K060457
          QUADROSTAR 532
          2
          Cleared 510(K)
        • K060455
          MULTISTAR
          2
          Cleared 510(K)
        • K053047
          FRAXEL SR LASER SYSTEM
          2
          Cleared 510(K)
        • K060216
          ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM
          2
          Cleared 510(K)
        • K052777
          LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D
          2
          Cleared 510(K)
        • K060234
          MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM
          2
          Cleared 510(K)
        • K052310
          CRYOFLOW 700, CRYOFLOW 1000
          2
          Cleared 510(K)
        • K053616
          POLARIS WR, ST APPLICATOR
          2
          Cleared 510(K)
        • K053511
          DA VINCI FEMTOSECOND SURGICAL LASER
          2
          Cleared 510(K)
        • K060338
          FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO
          2
          Cleared 510(K)
        • K060069
          PALOMAR LUXIR FRACTIONAL HANDPIECE
          2
          Cleared 510(K)
        • K053087
          VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM
          2
          Cleared 510(K)
        • K060033
          PROFILE MULTI-PLATFORM SYSTEM
          2
          Cleared 510(K)
        • K060395
          CRYO, MODEL V6.0
          2
          Cleared 510(K)
        • K053604
          WAVELIGHT IDAS
          2
          Cleared 510(K)
        • K053139
          FOTONA QX ND:YAG/KTP LASER SYSTEM
          2
          Cleared 510(K)
        • K053608
          CYNOSURE PHOTOGENICA V-STAR LASER
          2
          Cleared 510(K)
        • K042114
          MDL SERIES DIODE LASERS, MODEL MDL-10/15
          2
          Cleared 510(K)
        • K053421
          YAG MIR FAMILY LASER
          2
          Cleared 510(K)
        • K052991
          RADIANCY FACIAL SKINCARE DEVICE
          2
          Cleared 510(K)
        • K052442
          RADIANCY SKINSTATION WITH PSORIASIS LIGHT UNIT ASSEMBLY
          2
          Cleared 510(K)
        • K060050
          MEGABEAM SIDEFIBER FIBER OPTIC DELIVERY SYSTEM
          2
          Cleared 510(K)
        • K052680
          CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES
          2
          Cleared 510(K)
        • K053161
          SIROLASER
          2
          Cleared 510(K)
        • K053324
          CHROMOLITE SYSTEM
          2
          Cleared 510(K)
        • K051113
          QUANTA SYSTEM ETRNA GIOVINEZZA
          2
          Cleared 510(K)
        • K052848
          SPECTRA HAIR REMOVAL LASER
          2
          Cleared 510(K)
        • K053457
          VAPORMAX II
          2
          Cleared 510(K)
        • K052604
          STARLITE 2006
          2
          Cleared 510(K)
        • K052688
          ELLIPSE FLEX PPT, MODEL 9ESF7255
          2
          Cleared 510(K)
        • K052874
          SOPRANO HAIR REMOVAL DIODE LASER
          2
          Cleared 510(K)
        • K052526
          NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES
          2
          Cleared 510(K)
        • K052806
          BURANE
          2
          Cleared 510(K)
        • K052495
          ATRILAZE MALLEABLE ABLATION PROBE
          2
          Cleared 510(K)
        • K052336
          SPECTRAQUATTRO PULSED LIGHT SYSTEM
          2
          Cleared 510(K)
        • K051508
          MED FLASH II INTENSE PULSED LIGHT SYSTEM.
          2
          Cleared 510(K)
        • K051259
          VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
          2
          Cleared 510(K)
        • K052324
          POLARIS LV, LVA APPLICATOR
          2
          Cleared 510(K)
        • K050382
          AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K051876
          MULTIWAVE XR
          2
          Cleared 510(K)
        • K051671
          RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY
          2
          Cleared 510(K)
        • K052129
          LUMENIS 1000 INTEGRATED SLIT LAMP
          2
          Cleared 510(K)
        • K051996
          DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 30
          2
          Cleared 510(K)
        • K050824
          100W CERALAS D 980 LASER SYSTEM, MODEL D100
          2
          Cleared 510(K)
        • K051434
          COOLTOUCH ND:YAG LASER SYSTEMS, MODELS CT3S AND CTEV
          2
          Cleared 510(K)
        • K051428
          VTRAC EXCIMER LAMP SYSTEM
          2
          Cleared 510(K)
        • K050216
          OMNILUX REVIVE AND OMNILUX PLUS
          2
          Cleared 510(K)
        • K051287
          VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
          2
          Cleared 510(K)
        • K041893
          INTRALASE FS LASER
          2
          Cleared 510(K)
        • K043032
          DEALIGHT IPL
          2
          Cleared 510(K)
        • K051359
          CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY
          2
          Cleared 510(K)
        • K051268
          RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT
          2
          Cleared 510(K)
        • K050841
          FRAXEL SR LASER SYSTEM
          2
          Cleared 510(K)
        • K051255
          LUMIPHASE-R
          2
          Cleared 510(K)
        • K051399
          WAVELIGHT AURIGA
          2
          Cleared 510(K)
        • K050779
          CYNERGY MULTIPLEX LASER
          2
          Cleared 510(K)
        • K042630
          REVLIGHT SKIN CARE SYSTEM
          2
          Cleared 510(K)
        • K050696
          MEDLITE C1 Q-SWITCHED ND:YAG LASER
          2
          Cleared 510(K)
        • K050673
          CANDELA FAMILY OF PULSE DYE LASER SYSTEMS
          2
          Cleared 510(K)
        • K050738
          FT FIBER OPTIC DELIVERY SYSTEMS
          2
          Cleared 510(K)
        • K051167
          REVOLIX AND REVOLIX JR
          2
          Cleared 510(K)
        • K043377
          ZENO
          2
          Cleared 510(K)
        • K050453
          ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050
          2
          Cleared 510(K)
        • K050900
          MEDIOSTAR XT
          2
          Cleared 510(K)
        • K050672
          ERCHONIA EVRL LASER
          2
          Cleared 510(K)
        • K050950
          MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS
          2
          Cleared 510(K)
        • K050274
          DIODENT II DENTAL LASER SYSTEM
          2
          Cleared 510(K)
        • K041554
          AIP INTENSE PULSED LIGHT SYSTEM
          2
          Cleared 510(K)
        • K050165
          MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100
          2
          Cleared 510(K)
        • K050254
          SPECTRA-SP CO2 LASER SYSTEM
          2
          Cleared 510(K)
        • K050562
          OCULIGHT GL/GLX
          2
          Cleared 510(K)
        • K050796
          AURORA DS, DS APPLICATOR
          2
          Cleared 510(K)
        • K050679
          CUTERA SOLERA OPUS AESTHETIC PRODUCT
          2
          Cleared 510(K)
        • K050047
          CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY
          2
          Cleared 510(K)
        • K043521
          BIOSYAG 50 MED
          2
          Cleared 510(K)
        • K050293
          FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS
          2
          Cleared 510(K)
        • K050021
          VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
          2
          Cleared 510(K)
        • K043329
          OMNILUX REVIVE AND BLUE
          2
          Cleared 510(K)
        • K050412
          VAPORMAX
          2
          Cleared 510(K)
        • K050108
          SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS
          2
          Cleared 510(K)
        • K042319
          RELIANT LASER II SYSTEM AND ACCESSORIES
          2
          Cleared 510(K)
        • K050452
          AURORA SR AND SRA APPLICATOR
          2
          Cleared 510(K)
        • K043486
          PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01
          2
          Cleared 510(K)
        • K050317
          BURANE XL
          2
          Cleared 510(K)
        • K043575
          DERMILLUME, MODEL PRO1000
          2
          Cleared 510(K)
        • K043255
          ELLIPSE LIGHT SPT
          2
          Cleared 510(K)
        • K050218
          WAVELIGHT SINON
          2
          Cleared 510(K)
        • K043251
          CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B
          2
          Cleared 510(K)
        • K043046
          COOLTOUCH, MODEL CT3S
          2
          Cleared 510(K)
        • K050069
          CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT
          2
          Cleared 510(K)
        • K043173
          Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES
          2
          Cleared 510(K)
        • K040103
          SOUNDSKIN PHOTOTHERAPY SYSTEM
          2
          Cleared 510(K)
        • K041879
          PALOMAR LUX1064 HANDPIECE
          2
          Cleared 510(K)
        • K041086
          PALOMAR STARLUX PULSED LIGHT SYSTEM
          2
          Cleared 510(K)
        • K043429
          CYNERGY LASER
          2
          Cleared 510(K)
        • K042000
          MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS
          2
          Cleared 510(K)
        • K043319
          CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES
          2
          Cleared 510(K)
        • K040270
          OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM
          2
          Cleared 510(K)
        • K031425
          GENTLEWAVES LED PHOTOMODULATION DEVICE
          2
          Cleared 510(K)
        • K042785
          MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300
          2
          Cleared 510(K)
        • K041011
          ULTRALIGHT II ND:YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K043164
          PANALIGHT-BLU, MODEL 4175
          2
          Cleared 510(K)
        • K041957
          EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS
          2
          Cleared 510(K)
        • K040744
          ATRILAZE SOFT TISSUE ABLATION SYSTEM
          2
          Cleared 510(K)
        • K042968
          MCL 30 DERMABLATE ER:YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K042918
          MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2
          2
          Cleared 510(K)
        • K041242
          CANDELA SMOOTHBEAM LASER SYSTEM
          2
          Cleared 510(K)
        • K043012
          OMNIPULSE MINI, MODEL 2120
          2
          Cleared 510(K)
        • K041323
          PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA
          2
          Cleared 510(K)
        • K042211
          MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS
          2
          Cleared 510(K)
        • K041959
          POLARIS DS/COMET
          2
          Cleared 510(K)
        • K042496
          ADEPT ULTRALITE 532 LASER
          2
          Cleared 510(K)
        • K041969
          AURORA DS
          2
          Cleared 510(K)
        • K041943
          XTRAC XL, MODEL AL8000
          2
          Cleared 510(K)
        • K040563
          LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT)
          2
          Cleared 510(K)
        • K042439
          AZURYT MODEL CLT 1401, CO2 SURGICAL LASER SYSTEM
          2
          Cleared 510(K)
        • K041994
          MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM
          2
          Cleared 510(K)
        • K041767
          COOLCUBE COOLPEN
          2
          Cleared 510(K)
        • K042474
          ARION
          2
          Cleared 510(K)
        • K041739
          EDWARDS E360 SURGICAL ABLATION DEVICE
          2
          Cleared 510(K)
        • K040921
          COOLTOUCH, MODEL NS 160
          2
          Cleared 510(K)
        • K032991
          LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX
          2
          Cleared 510(K)
        • K041930
          VARILITE LASER SYSTEM
          2
          Cleared 510(K)
        • K042139
          VISULAS YAG III
          2
          Cleared 510(K)
        • K041660
          TRIMEDYNE HOLMIUM LASER SYSTEMS
          2
          Cleared 510(K)
        • K041829
          FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS
          2
          Cleared 510(K)
        • K041419
          LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM
          2
          Cleared 510(K)
        • K041262
          DURALITE-GL
          2
          Cleared 510(K)
        • K041721
          LVI AESTHETIC LASER
          2
          Cleared 510(K)
        • K041710
          VERSAWAVE DENTAL ER:YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K041103
          ACNELIFT
          2
          Cleared 510(K)
        • K030290
          PERIOLASE ND:YAG DENTAL LASER SYSTEM
          2
          Cleared 510(K)
        • K031140
          WATERLASE
          2
          Cleared 510(K)
        • K041569
          CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002
          2
          Cleared 510(K)
        • K040617
          RELIANT LASER SYSTEM II
          2
          Cleared 510(K)
        • K040659
          MCCUE PLC ENERGIST ULTRA VARIABLE PULSED LIGHT SYSTEM
          2
          Cleared 510(K)
        • K032397
          DUAL YELLOW LASER, MODEL DUAL YELLOW D10B
          2
          Cleared 510(K)
        • K041095
          PHOTOSILK PULSED LIGHT SYSTEM
          2
          Cleared 510(K)
        • K040433
          SINON
          2
          Cleared 510(K)
        • K040384
          MYDON C
          2
          Cleared 510(K)
        • K040424
          LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120
          2
          Cleared 510(K)
        • K040294
          LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980
          2
          Cleared 510(K)
        • K030810
          COOLAN 300
          2
          Cleared 510(K)
        • K040289
          SMARTLITE D FREQUENCY DOUBLED ND:YAG LASER
          2
          Cleared 510(K)
        • K040727
          CRYO 5
          2
          Cleared 510(K)
        • K040131
          COOLTOUCH; COOLTOUCH II; AND COOLTOUCH CT3 ND:YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K033183
          RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012
          2
          Cleared 510(K)
        • K040055
          POLYLASE LP
          2
          Cleared 510(K)
        • K032797
          DELIGHT DENTAL ER: YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K040234
          LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM
          2
          Cleared 510(K)
        • K040081
          PALOMAR LUXV HANDPIECE
          2
          Cleared 510(K)
        • K033072
          LUCENTLITE, MODEL IMD 010
          2
          Cleared 510(K)
        • K034011
          GEMINI SURGICAL LASER SYSTEM & ACCESSORIES
          2
          Cleared 510(K)
        • K040005
          PROFILE 2000/3000 LASER SYSTEM
          2
          Cleared 510(K)
        • K040156
          IFL PROFESSIONAL SYSTEM, MODEL C100
          2
          Cleared 510(K)
        • K032863
          CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D50
          2
          Cleared 510(K)
        • K032864
          CERALAS D 810 DIODE LASER SYSTEM, MODEL D15
          2
          Cleared 510(K)
        • K033933
          POWERLITE 600 EX SYSTEM
          2
          Cleared 510(K)
        • K033549
          STARLUX PULSED LIGHT SYSTEM
          2
          Cleared 510(K)
        • K032459
          PROFILE 1320 LASER SYSTEM
          2
          Cleared 510(K)
        • K033251
          THE FRIENDLYLIGHT ND: YAG LASERS
          2
          Cleared 510(K)
        • K033259
          LIGHT AGE Q-CLEAR LASER, MODEL 701-1101
          2
          Cleared 510(K)
        • K033962
          LAD (EPITURE EASYTOUCH), MODEL LAD-08
          2
          Cleared 510(K)
        • K033354
          FEMTEC LASER MICROKERATOME
          2
          Cleared 510(K)
        • K034030
          APOGEE ELITE
          2
          Cleared 510(K)
        • K030523
          WATERLASE
          2
          Cleared 510(K)
        • K032514
          AC APPLICATOR, AURORA AC
          2
          Cleared 510(K)
        • K032667
          FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW)
          2
          Cleared 510(K)
        • K033176
          TRISTAR AESTHETIC WORKSTATION LASER
          2
          Cleared 510(K)
        • K033437
          SPHINX LASER SYSTEMS
          2
          Cleared 510(K)
        • K033461
          CANDELA VBEAM PULSE DYE LASER SYSTEM
          2
          Cleared 510(K)
        • K033331
          CANDELA CBEAM PULSE DYE LASER SYSTEM
          2
          Cleared 510(K)
        • K033423
          REVOLIX LASER SYSTEMS
          2
          Cleared 510(K)
        • K033799
          CLINICAL LASETTE P-200
          2
          Cleared 510(K)
        • K032944
          YA-MAN LASER 21
          2
          Cleared 510(K)
        • K032846
          SPECTRA PULSED DIODE LASER, MODEL DR-1
          2
          Cleared 510(K)
        • K032205
          RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY
          2
          Cleared 510(K)
        • K033586
          MODIFICATION TO AURORA DS
          2
          Cleared 510(K)
        • K032735
          SPECTRA QT: Q-SWITCHED ND: YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K030834
          CANDELA SMOOTHBEAM LASER SYSTEM
          2
          Cleared 510(K)
        • K031671
          POLARIS WR
          2
          Cleared 510(K)
        • K032383
          MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM
          2
          Cleared 510(K)
        • K033237
          VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE
          2
          Cleared 510(K)
        • K032260
          ARAMIS II DERMATOLOGICAL LASER
          2
          Cleared 510(K)
        • K032539
          CYNOSURE PHOTOGENICA SV LASER
          2
          Cleared 510(K)
        • K024206
          AURA ISURGICAL LASER SYSTEM & ACCESSORIES
          2
          Cleared 510(K)
        • K032460
          PROFILE BBL SYSTEM
          2
          Cleared 510(K)
        • K031795
          RELIANT LASER SYSTEM
          2
          Cleared 510(K)
        • K033172
          CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS
          2
          Cleared 510(K)
        • K031819
          DIO-DENT 10 DENTAL DIODE LASER
          2
          Cleared 510(K)
        • K032599
          MEDICAL LASER TECHNOLOGIES, LLC MTL ERBIUM:YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K033181
          SPR SYSTEM
          2
          Cleared 510(K)
        • K032704
          INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30
          2
          Cleared 510(K)
        • K032703
          INNOVATECH STRAIGHT LASER PROBE, MODEL 420-10
          2
          Cleared 510(K)
        • K032221
          ADEPT 1064/755 LASER
          2
          Cleared 510(K)
        • K032220
          ADEPT 1064/532 LASER
          2
          Cleared 510(K)
        • K032218
          ADEPT 1064/532/755 LASER
          2
          Cleared 510(K)
        • K032565
          CYNOSURE PHOTOGENICA VL
          2
          Cleared 510(K)
        • K030539
          LASERSMILE
          2
          Cleared 510(K)
        • K032357
          NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES
          2
          Cleared 510(K)
        • K031125
          CYNOSURE SMART FILE ND:YAG LASERS
          2
          Cleared 510(K)
        • K032085
          GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000
          2
          Cleared 510(K)
        • K032805
          MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
          2
          Cleared 510(K)
        • K032023
          W.O.M. LASER U100PLUS
          2
          Cleared 510(K)
        • K031440
          SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER
          2
          Cleared 510(K)
        • K031389
          CYNOSURE SMART 2940D ER:YAG LASER
          2
          Cleared 510(K)
        • K031960
          INTRALASE FS LASER
          2
          Cleared 510(K)
        • K030846
          CANDELA SMOOTHBEAM LASER SYSTEM
          2
          Cleared 510(K)
        • K031805
          BLU-U, MODEL 4170
          2
          Cleared 510(K)
        • K031954
          COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS
          2
          Cleared 510(K)
        • K032204
          MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
          2
          Cleared 510(K)
        • K032191
          OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM
          2
          Cleared 510(K)
        • K031489
          PITANGA
          2
          Cleared 510(K)
        • K031988
          AURORA DS
          2
          Cleared 510(K)
        • K031993
          AURORA SR
          2
          Cleared 510(K)
        • K031451
          XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL7000
          2
          Cleared 510(K)
        • K030033
          LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES
          2
          Cleared 510(K)
        • K030426
          OMNILUX RED
          2
          Cleared 510(K)
        • K030342
          LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS
          2
          Cleared 510(K)
        • K031690
          CYNOSURE YAG FAMILY LASER (PHOTOGENICA YAG AND ACCLAIM)
          2
          Cleared 510(K)
        • K031258
          CYNOSURE PHOTOLIGHT PL
          2
          Cleared 510(K)
        • K024204
          FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K031680
          SPECTRAPULSE
          2
          Cleared 510(K)
        • K024259
          PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300
          2
          Cleared 510(K)
        • K024189
          NLITE SYSTEM, MODEL#: A00-1025/A00-1033
          2
          Cleared 510(K)
        • K030897
          SKINSTATION
          2
          Cleared 510(K)
        • K024093
          MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS
          2
          Cleared 510(K)
        • K031233
          ANDIODYNAMICS, INC. ELVS PROCEDURE KIT
          2
          Cleared 510(K)
        • K030883
          OMNILUX BLUE
          2
          Cleared 510(K)
        • K030654
          VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
          2
          Cleared 510(K)
        • K023881
          PROFILE 1064 LASER SYSTEM
          2
          Cleared 510(K)
        • K031488
          CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASER
          2
          Cleared 510(K)
        • K030700
          CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT
          2
          Cleared 510(K)
        • K031317
          SMART 2940 D ER: YAG LASER
          2
          Cleared 510(K)
        • K031184
          COOL TOUCH 3
          2
          Cleared 510(K)
        • K030805
          MYTHOS 500
          2
          Cleared 510(K)
        • K030527
          LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS
          2
          Cleared 510(K)
        • K030508
          DEPILASE TRIO LASE LASER SYSTEM
          2
          Cleared 510(K)
        • K030510
          DEPILASE TWIN YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K030480
          L600 HAIR REMOVAL
          2
          Cleared 510(K)
        • K030453
          COOLTOUCH ND: YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K031224
          SMARTXIDE
          2
          Cleared 510(K)
        • K030506
          DEPILASE YAG LASE PLUS LASER SYSTEM
          2
          Cleared 510(K)
        • K030423
          POWERLITE 600 EP SYSTEM
          2
          Cleared 510(K)
        • K023734
          ARAMIS II DERMATOLOGICAL LASER
          2
          Cleared 510(K)
        • K030959
          BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100
          2
          Cleared 510(K)
        • K030235
          F1 DIODE LASER SYSTEM
          2
          Cleared 510(K)
        • K030181
          INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM
          2
          Cleared 510(K)
        • K030147
          LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS
          2
          Cleared 510(K)
        • K023547
          DIOLASE 980 D LASER SYSTEM
          2
          Cleared 510(K)
        • K030186
          POLRIS LV
          2
          Cleared 510(K)
        • K024371
          CANDELA GENTLE LASE FAMILY OF LASER SYSTEM
          2
          Cleared 510(K)
        • K023257
          ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX
          2
          Cleared 510(K)
        • K024260
          CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
          2
          Cleared 510(K)
        • K023954
          ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES
          2
          Cleared 510(K)
        • K022923
          CANDELA GENTLE YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K024335
          CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
          2
          Cleared 510(K)
        • K024061
          PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00
          2
          Cleared 510(K)
        • K023899
          DUAL YELLOW LASER, MODEL D10B
          2
          Cleared 510(K)
        • K022709
          MEDLITE Q-SWITHCED LASER
          2
          Cleared 510(K)
        • K030338
          ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002
          2
          Cleared 510(K)
        • K024064
          POLARIS DS
          2
          Cleared 510(K)
        • K022807
          MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA
          2
          Cleared 510(K)
        • K023967
          PALOMAR Q-YAG ND:YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K023624
          SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921
          2
          Cleared 510(K)
        • K022951
          CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG
          2
          Cleared 510(K)
        • K022341
          TERABYTE 2000 HAIR REMOVER
          2
          Cleared 510(K)
        • K022884
          CANDELA SMOOTHBEAM LASER SYSTEM
          2
          Cleared 510(K)
        • K023464
          VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR
          2
          Cleared 510(K)
        • K021222
          LAD, MODEL LAD-01
          2
          Cleared 510(K)
        • K024088
          CERALAS D 980 LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT, MODEL: D15 AND D25
          2
          Cleared 510(K)
        • K022466
          PROFILE 1320 LASER SYSTEM
          2
          Cleared 510(K)
        • K023962
          NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160
          2
          Cleared 510(K)
        • K023193
          CANDELA GENTLE YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K022607
          SPECTRAPULSE
          2
          Cleared 510(K)
        • K023081
          PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION)
          2
          Cleared 510(K)
        • K023041
          W.O.M. LASER U100
          2
          Cleared 510(K)
        • K021548
          FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K023543
          EVLT KIT AND D15PLUS AND D30PLUS DIODE
          2
          Cleared 510(K)
        • K022839
          FOTONA DUALIS PLUS ND:YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K022837
          FOTONA TANDEM LASER SYSTEM
          2
          Cleared 510(K)
        • K022838
          FOTONA DUALIS ER:YAG/KTP LASER SYSTEM
          2
          Cleared 510(K)
        • K022817
          COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II
          2
          Cleared 510(K)
        • K022464
          EQUILASE SYSTEM
          2
          Cleared 510(K)
        • K021444
          CYNOSURE PHOTOGENICA SV
          2
          Cleared 510(K)
        • K022760
          MILLENNIUM MICROSURGICAL SYSTEM
          2
          Cleared 510(K)
        • K022655
          TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH
          2
          Cleared 510(K)
        • K022610
          CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160
          2
          Cleared 510(K)
        • K022583
          FLASH 1
          2
          Cleared 510(K)
        • K022060
          LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE ACCESSORIES
          2
          Cleared 510(K)
        • K020339
          DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEM
          2
          Cleared 510(K)
        • K023182
          INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS
          2
          Cleared 510(K)
        • K022381
          PROFILE 1320 LASER SYSTEM
          2
          Cleared 510(K)
        • K022378
          PLASMALITE PULSED LIGHT SYSTEM
          2
          Cleared 510(K)
        • K022351
          DIODENT DENTAL LASER SYSTEM
          2
          Cleared 510(K)
        • K022338
          OPTICAL INTEGRITY GENERAL SHAPED FIBER
          2
          Cleared 510(K)
        • K022327
          NOVUS SPECTRA
          2
          Cleared 510(K)
        • K020839
          QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, VX, DL
          2
          Cleared 510(K)
        • K022228
          FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES
          2
          Cleared 510(K)
        • K022226
          ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS
          2
          Cleared 510(K)
        • K014128
          CANDELA SMOOTHBEAM LASER SYSTEM
          2
          Cleared 510(K)
        • K022266
          AURORA SR
          2
          Cleared 510(K)
        • K022181
          NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES
          2
          Cleared 510(K)
        • K013974
          RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A
          2
          Cleared 510(K)
        • K021975
          LASERSYSTEM BEAUTYSTAR 532
          2
          Cleared 510(K)
        • K021946
          CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEM
          2
          Cleared 510(K)
        • K021848
          CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, 1160
          2
          Cleared 510(K)
        • K022568
          PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIR
          2
          Cleared 510(K)
        • K022569
          PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONS
          2
          Cleared 510(K)
        • K022544
          DORNIER MEDILAS H LASER FIBER CABLES
          2
          Cleared 510(K)
        • K021696
          20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25
          2
          Cleared 510(K)
        • K021686
          LASER FIBER GF500
          2
          Cleared 510(K)
        • K021724
          DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS
          2
          Cleared 510(K)
        • K021650
          ATHOSCAN FOR THE ATHOS LASER CONSTANS COOLING HAND PIECE FOR THE ATHOS LASER
          2
          Cleared 510(K)
        • K013623
          CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420
          2
          Cleared 510(K)
        • K013691
          CERALAS D DIODE LASER SYSTEM, MODEL # D50
          2
          Cleared 510(K)
        • K021550
          LUMENIS SELECTA DUET
          2
          Cleared 510(K)
        • K021508
          OPUSDUO EC DENTAL LASER SYSTEM
          2
          Cleared 510(K)
        • K021304
          PROLITE PULSED LIGHT SYSTEM
          2
          Cleared 510(K)
        • K021616
          DELIGHT DENTAL ER: YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K021149
          AURORA DS
          2
          Cleared 510(K)
        • K021180
          CANDELA VBEAM PULSED DYE LASER SYSTEM
          2
          Cleared 510(K)
        • K020021
          LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION)
          2
          Cleared 510(K)
        • K021227
          SOFTLASE G2-SURGICAL DIODE LASER SYSTEM
          2
          Cleared 510(K)
        • K020958
          CANDELA CBEAM PULSED DYE LASER SYSTEM
          2
          Cleared 510(K)
        • K020941
          PALOMAR LUXG HANDPIECE
          2
          Cleared 510(K)
        • K020856
          SPATOUCH PHOTOEPILATION SYSTEM
          2
          Cleared 510(K)
        • K020835
          CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60
          2
          Cleared 510(K)
        • K020729
          NLITE SYSTEM,MODEL A00-1051
          2
          Cleared 510(K)
        • K014040
          FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS
          2
          Cleared 510(K)
        • K020673
          WAVE FORM MANUFACTURING PROLASE GENERAL SHAPED FIBER
          2
          Cleared 510(K)
        • K013021
          LIGHTLANCE LASER SKIN PERFORATOR
          2
          Cleared 510(K)
        • K020849
          APEX 800 LASER SYSTEM, MODEL APEX 800
          2
          Cleared 510(K)
        • K020847
          XTRAC EXCIMER LASER SYSTEM, MODEL AL7000
          2
          Cleared 510(K)
        • K020513
          EPY-50
          2
          Cleared 510(K)
        • K020453
          PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER
          2
          Cleared 510(K)
        • K013300
          MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM
          2
          Cleared 510(K)
        • K020697
          DEPILASE TWIN YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K020099
          MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE
          2
          Cleared 510(K)
        • K020072
          ATHOS LASER
          2
          Cleared 510(K)
        • K020071
          VIRIDIS DERMA LASER
          2
          Cleared 510(K)
        • K020973
          EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO
          2
          Cleared 510(K)
        • K014272
          PERIOLASE ND:YAG DENTAL LASER SYSTEM
          2
          Cleared 510(K)
        • K014253
          DERMACHILLER 4
          2
          Cleared 510(K)
        • K014236
          CLINICON WAVEGUIDE PLATFORM WITH INTERCONNECT FOR LUXAR ACCESSORIES
          2
          Cleared 510(K)
        • K013201
          CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR
          2
          Cleared 510(K)
        • K014057
          DERMASTAR ER:YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K014035
          COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS
          2
          Cleared 510(K)
        • K020463
          DEPILASE YAG LASE PLUS LASER SYSTEM
          2
          Cleared 510(K)
        • K013941
          PULSION FS LASER KERATOME
          2
          Cleared 510(K)
        • K013216
          DIODENT DENTAL LASER SYSTEM
          2
          Cleared 510(K)
        • K013940
          LASER SYSTEM YELLOWSTAR
          2
          Cleared 510(K)
        • K020412
          DEPILASE TWIN LASE LASER SYSTEM
          2
          Cleared 510(K)
        • K013825
          CANDELA SMOOTHBEAM LASER SYSTEM
          2
          Cleared 510(K)
        • K014048
          CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS
          2
          Cleared 510(K)
        • K013748
          CANDELA SCLERO LONG PULSE LASER (AKA VBEAM)
          2
          Cleared 510(K)
        • K013864
          MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60
          2
          Cleared 510(K)
        • K020107
          SMARTEPIL
          2
          Cleared 510(K)
        • K012398
          DIOMED 15 DIODE LASER
          2
          Cleared 510(K)
        • K014234
          MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER
          2
          Cleared 510(K)
        • K013461
          NLITE SYSTEM,MODEL A00-1025
          2
          Cleared 510(K)
        • K014130
          NLITE SYSTEM
          2
          Cleared 510(K)
        • K014100
          OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND
          2
          Cleared 510(K)
        • K013365
          PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS
          2
          Cleared 510(K)
        • K013366
          PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR
          2
          Cleared 510(K)
        • K011939
          FOTONA DUALIS, FOTONA DUALIS PLUS
          2
          Cleared 510(K)
        • K013193
          MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE
          2
          Cleared 510(K)
        • K011960
          LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S4)
          2
          Cleared 510(K)
        • K013901
          MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM)
          2
          Cleared 510(K)
        • K013493
          INDIGO OPTIMA LASER SYSTEM
          2
          Cleared 510(K)
        • K013028
          PALOMAR SLP 1000
          2
          Cleared 510(K)
        • K013047
          FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K012071
          ENT LASERVISION
          2
          Cleared 510(K)
        • K010771
          PERIOLASE ND:YAG DENTAL LASER SYSTEM
          2
          Cleared 510(K)
        • K012806
          CYNOSURE PHOTOGENICA VL
          2
          Cleared 510(K)
        • K011322
          DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE
          2
          Cleared 510(K)
        • K013499
          DIOMED 15 PLUS AND DIOMED 30PLUS LASERS
          2
          Cleared 510(K)
        • K012790
          CYNOSURE PHOTOGENICA ER
          2
          Cleared 510(K)
        • K013402
          VISULAS 532S
          2
          Cleared 510(K)
        • K012682
          REPROCESSED LASER PROBE
          2
          Cleared 510(K)
        • K011174
          PARADIGM-FONTONA PEROVSKITE ND: YAP LASER SYSTEM AND ACCESSORIES
          2
          Cleared 510(K)
        • K011070
          DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR
          2
          Cleared 510(K)
        • K012552
          SCITON IMAGE HAIR REMOVAL LASER
          2
          Cleared 510(K)
        • K012545
          ARAMIS DERMATLOGIC LASER
          2
          Cleared 510(K)
        • K011175
          W.O.M. LASER U100
          2
          Cleared 510(K)
        • K013043
          CANDELA CLEARBEAM PULSED DYE LASER
          2
          Cleared 510(K)
        • K011021
          LASER 20
          2
          Cleared 510(K)
        • K012127
          PULSEMASTER ERBIUM DENTAL LASER SYSTEM
          2
          Cleared 510(K)
        • K010804
          MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS
          2
          Cleared 510(K)
        • K010715
          AL-40
          2
          Cleared 510(K)
        • K012982
          COOLTOUCH VARIZOOM
          2
          Cleared 510(K)
        • K010618
          PALOMAR DERMALUX PULSED LIGHT SYSTEM
          2
          Cleared 510(K)
        • K011828
          CYNOSURE ACCLAIM DERMATOLOGY LASER
          2
          Cleared 510(K)
        • K011769
          OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND
          2
          Cleared 510(K)
        • K011747
          PALOMAR LC 100 DIODE LASER
          2
          Cleared 510(K)
        • K011703
          LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES
          2
          Cleared 510(K)
        • K002890
          INTRALASE 600C LASER KERATOME
          2
          Cleared 510(K)
        • K011423
          INPULSE DENTAL LASER
          2
          Cleared 510(K)
        • K011382
          XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000
          2
          Cleared 510(K)
        • K011207
          LASER PERIPHERALS REUSABLE HOLMIUM FIBER
          2
          Cleared 510(K)
        • K011092
          CANDELA SPTL-1E PULSED DYE LASER
          2
          Cleared 510(K)
        • K011041
          WATERLASE, MILLENNIUM
          2
          Cleared 510(K)
        • K011677
          MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER
          2
          Cleared 510(K)
        • K010927
          MODIFICATION TO PROLITE PULSED LIGHT SYSTEM
          2
          Cleared 510(K)
        • K010928
          PROLITE VL PULSED LIGHT SYSTEM
          2
          Cleared 510(K)
        • K011409
          SLT LASERPRO CTH HOLMIUM LASER SYSTEM
          2
          Cleared 510(K)
        • K010885
          UNI-LASER 470
          2
          Cleared 510(K)
        • K010580
          PALOMAR SLP 1000
          2
          Cleared 510(K)
        • K003318
          PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X
          2
          Cleared 510(K)
        • K010834
          LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES
          2
          Cleared 510(K)
        • K010689
          MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM
          2
          Cleared 510(K)
        • K010316
          COOLTOUCH VARIA ND:YAG LASER SYSTEM; COOLTOUCH VARIA-II ND:YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K010284
          LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
          2
          Cleared 510(K)
        • K003440
          SOFTLASE - SURGICAL DIODE LASER SYSTEM
          2
          Cleared 510(K)
        • K010113
          LASER MECHANISMS LASER SCANNING SYSTEM
          2
          Cleared 510(K)
        • K010104
          CANDELA LONG PULSE ND:YAG
          2
          Cleared 510(K)
        • K010046
          NUVOLASE 532 MEDICAL LASER SYSTEM
          2
          Cleared 510(K)
        • K010005
          CYNOSURE PHOTOGENICA DL
          2
          Cleared 510(K)
        • K004039
          CYNOSURE PHOTOGENICA NEO-V
          2
          Cleared 510(K)
        • K004021
          F1 DIODE LASER SYSTEM
          2
          Cleared 510(K)
        • K003993
          DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE)
          2
          Cleared 510(K)
        • K004006
          SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER
          2
          Cleared 510(K)
        • K004014
          MD 30 COMPACT
          2
          Cleared 510(K)
        • K003953
          INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF001
          2
          Cleared 510(K)
        • K003952
          INDIGO LASEROPTIC TREATMENT SYSTEM
          2
          Cleared 510(K)
        • K003955
          LASEREX INTEGRE, MODEL LP2532
          2
          Cleared 510(K)
        • K003614
          LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM
          2
          Cleared 510(K)
        • K010041
          SLT DIFFUSER FIBER
          2
          Cleared 510(K)
        • K003765
          LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
          2
          Cleared 510(K)
        • K010285
          CONTOUR PROFILE LASER
          2
          Cleared 510(K)
        • K003886
          PALOMAR SPALIGHT PULSED LIGHT SYSTEM
          2
          Cleared 510(K)
        • K003705
          XTRAC EXCIMER LASER SYSTEM, MODEL AL7000
          2
          Cleared 510(K)
        • K003715
          COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH II
          2
          Cleared 510(K)
        • K003885
          VISULAS YAG II
          2
          Cleared 510(K)
        • K003541
          DENLASER, MODEL 800
          2
          Cleared 510(K)
        • K003460
          PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K003385
          TWILITE, TWILITE WHITE
          2
          Cleared 510(K)
        • K003202
          FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II
          2
          Cleared 510(K)
        • K003151
          MICROPOBE SERIES OF LASERS AND ACCESSORIES
          2
          Cleared 510(K)
        • K003781
          COOLTOUCH VARIA-II ND:YAG LASER SYSTEM
          2
          Cleared 510(K)
        • K002308
          OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A
          2
          Cleared 510(K)
        • K003147
          LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION)
          2
          Cleared 510(K)
        • K002899
          OPUS 20, MODEL 1ST
          2
          Cleared 510(K)
        • K002884
          PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES
          2
          Cleared 510(K)
        • K002853
          SCITON IMAGE HAIR REMOVAL LASER
          2
          Cleared 510(K)
        • K001211
          MODIFICATION TO INTRALASE 600C LASER KERATOME
          2
          Cleared 510(K)
        • K003046
          IMAGE VASCULAR LASER
          2
          Cleared 510(K)
        • K002649
          ARAMIS DERMATOLOGICAL LASER
          2
          Cleared 510(K)
        • K000023
          FRIENDLY LIGHT ER:YAG PULSED LASER
          2
          Cleared 510(K)
        • K002421
          CANDELA MID IR DIODE LASER SYSTEM
          2
          Cleared 510(K)
        • K001676
          OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A
          2
          Cleared 510(K)
        • K000317
          SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM
          2
          Cleared 510(K)
        • K001990
          DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES
          2
          Cleared 510(K)
        • K000929
          PROLITE PULSED LIGHT SYSTEM
          2
          Cleared 510(K)
        • K002228
          PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X
          2
          Cleared 510(K)
        • K002296
          CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15
          2
          Cleared 510(K)
        • K001093
          CANDELA SPTL-1B PULSED DYE LASER
          2
          Cleared 510(K)
        • K000727
          BUFFLIGHT CLT SURGICAL LASER SYSTEM
          2
          Cleared 510(K)
        • K002072
          PROLITE VL PULSED LIGHT SYSTEM
          2
          Cleared 510(K)
        • K002032
          C02 LASER MULTIPULSE
          2
          Cleared 510(K)
        • K001784
          VIRIDIS LASER
          2
          Cleared 510(K)
        • K001704
          ATHOS
          2
          Cleared 510(K)
        • K000811
          NLITE SYSTEM, SLS MODEL NUMBER A00-1025
          2
          Cleared 510(K)
        • K000158
          VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9
          2
          Cleared 510(K)
        • K001589
          CANDELA DYNAMIC COOLING DEVICE
          2
          Cleared 510(K)
        • K002347
          COOLTOUCH II
          2
          Cleared 510(K)
        • K001975
          CERALAS D10 810NM LASER, MODEL CERALAS D10-60
          2
          Cleared 510(K)
        • K001527
          FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES
          2
          Cleared 510(K)
        • K990119
          EPI-STAR SURGICAL LASER SYSTER
          2
          Cleared 510(K)
        • K001746
          LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (FAMILY OF PRODUCTS)
          2
          Cleared 510(K)
        • K001511
          O-LAS OPHTHALMIC PHOTODISRUPTOR
          2
          Cleared 510(K)
        • K993328
          SURGILIGHT, INC EXCIMER LASER
          2
          Cleared 510(K)
        • K001322
          PERFORMER 30 HPS
          2
          Cleared 510(K)
        • K001031
          URANUS, COMFORTOUCH LASER SYSTEM
          2
          Cleared 510(K)
        • K993154
          LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM
          2
          Cleared 510(K)
        • K992757
          CYNOSURE APOGEE-TKS DERMATOLOGICAL LASER
          2
          Cleared 510(K)
        • K000990
          OPUS 10 DENTAL DIODE LASER
          2
          Cleared 510(K)
        • K000072
          DORNIER MEDILAS D SKINPULSE
          2
          Cleared 510(K)
        • K994116
          LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM)
          2
          Cleared 510(K)
        • K994260
          CANDELA GENTLELASE GL DERMATOLOGICAL LASER
          2
          Cleared 510(K)
        • K001243
          DORNIER MEDILAS H
          2
          Cleared 510(K)
        • K994225
          PALOMAR SLP 2000
          2
          Cleared 510(K)
        • K000693
          UMECO OPTIMA MULTILINE LASER SYSTEM
          2
          Cleared 510(K)
        • K000503
          MEDART 520 COOLING SYSTEM
          2
          Cleared 510(K)
        • K993815
          UNI-LASER 430
          2
          Cleared 510(K)
        • K001263
          SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040
          2
          Cleared 510(K)
        • K000805
          KAVO K.E.Y. LASER 1242
          2
          Cleared 510(K)
        • K000982
          A100 AESTHETIC DIODE LASER
          2
          Cleared 510(K)
        • K992597
          LORAD LT-100 LASER TREATMENT SYSTEM
          2
          Cleared 510(K)
        • K000222
          UM-L25
          2
          Cleared 510(K)
        • K000106
          DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES
          2
          Cleared 510(K)
        • K000192
          E3 MICROPROB SERIES OF LASERS AND ACCESSORIES
          2
          Cleared 510(K)
        • K000498
          COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER
          2
          Cleared 510(K)
        • K000490
          CYNOSURE PHOTOGENICA VLS-STAR
          2
          Cleared 510(K)
        • K990718
          ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)
          2
          Cleared 510(K)
        • K991798
          ACME MEDICAL AESTHETIC ND:YAG LASER
          2
          Cleared 510(K)
        • K994014
          ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT
          2
          Cleared 510(K)
        • K993834
          SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C
          2
          Cleared 510(K)
        • K993911
          CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50
          2
          Cleared 510(K)
        • K993828
          CERALAS D10 810NM DIODE LASER
          2
          Cleared 510(K)
        • K992914
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          2
          Cleared 510(K)
        • K991935
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          2
          Cleared 510(K)
        • K993671
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          2
          Cleared 510(K)
        • K994273
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          2
          Cleared 510(K)
        • K994437
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          2
          Cle