Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- Diagnostic DevicesCFR Sub-Part
- General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- MiscellaneousMiscellaneous
- Neurological Surgical DevicesCFR Sub-Part
- Physical Medicine Therapeutic DevicesCFR Sub-Part
- Prosthetic DevicesCFR Sub-Part
- Surgical DevicesCFR Sub-Part
- EMFKnife, Surgical1Product Code
- EPTMicroscope, Surgical1Product Code
- EPWSupport, Head, Surgical, Ent1Product Code
- OEJTransurethral Electrosurgical Unit, Benign Prostatic Hyperplasia2Product Code
- FAZSystem, Cryosurgical, Liquid Nitrogen, For Urology2Product Code
- OEKWater-Induced Thermotherapy System, Benign Prostatic Hyperplasia2Product Code
- GAGStapler, Surgical2Product Code
- DWGElectrosurgical Device2Product Code
- DWHBlade, Saw, Surgical, Cardiovascular1Product Code
- DWISaw, Electrically Powered1Product Code
- DWONeedle, Biopsy, Cardiovascular1Product Code
- QQSStapler, Skin1Product Code
- BTAPump, Portable, Aspiration (Manual Or Powered)2Product Code
- BWAUnit, Electrosurgical And Coagulation, With Accessories2Product Code
- BWNTable And Attachments, Operating-Room1Product Code
- BWPShoe And Shoe Cover, Conductive1Product Code
- FGYCannula, Injection1Product Code
- FHMApparatus, Suturing, Stomach And Intestinal1Product Code
- FHRNeedle, Gastro-Urology1Product Code
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature2Product Code
- FNWPad, Kelly2Product Code
- FQOTable, Operating-Room, Ac-Powered1Product Code
- FQPLamp, Operating-Room2Product Code
- FSETable, Operating-Room, Manual1Product Code
- FSHTray, Surgical, Needle1Product Code
- FSMTray, Surgical, Instrument1Product Code
- FSOMicroscope, Surgical, General & Plastic Surgery1Product Code
- FSPLoupe, Diagnostic/Surgical1Product Code
- FSQLight, Surgical, Instrument2Product Code
- FSSLight, Surgical, Floor Standing2Product Code
- FSTLight, Surgical, Fiberoptic2Product Code
- FSWLight, Surgical, Endoscopic2Product Code
- FSXLight, Surgical, Connector2Product Code
- FSYLight, Surgical, Ceiling Mounted2Product Code
- FSZLight, Surgical, Carrier2Product Code
- FTALight, Surgical, Accessories2Product Code
- FTCLight, Ultraviolet, Dermatological2Product Code
- FTDLamp, Surgical2Product Code
- FTFIlluminator, Non-Remote2Product Code
- FTGIlluminator, Remote2Product Code
- FTHCamera, Still, Microsurgical1Product Code
- FTSCamera, Cine, Endoscopic, With Audio1Product Code
- FTTCamera, Still, Surgical1Product Code
- FTXMirror, General & Plastic Surgery1Product Code
- FTYTape, Measuring, Rulers And Calipers1Product Code
- FWBCamera, Television, Surgical, Without Audio1Product Code
- FWCCamera, Television, Surgical, With Audio1Product Code
- FWDCamera, Television, Microsurgical, Without Audio1Product Code
- FWECamera, Television, Microsurgical, With Audio1Product Code
- FWFCamera, Television, Endoscopic, Without Audio1Product Code
- FWGCamera, Television, Endoscopic, With Audio1Product Code
- FWHCamera, Cine, Surgical, Without Audio1Product Code
- FWICamera, Cine, Surgical, With Audio1Product Code
- FWJCamera, Cine, Microsurgical, Without Audio1Product Code
- FWKCamera, Cine, Microsurgical, With Audio1Product Code
- FWLCamera, Cine, Endoscopic, Without Audio1Product Code
- FWWTable, Operating-Room, Pneumatic1Product Code
- FWXTable, Operating-Room, Mechanical1Product Code
- FWYTable, Operating-Room, Non-Electrical1Product Code
- FWZOperating Room Accessories Table Tray1Product Code
- FXMCamera, Still, Endoscopic1Product Code
- FXNTape, Camera, Surgical1Product Code
- FXQLens, Camera, Surgical1Product Code
- FXRHolder, Camera, Surgical1Product Code
- FXSFrame, Camera, Surgical1Product Code
- FXTFilm, Camera, Surgical1Product Code
- FXWShoes, Operating-Room1Product Code
- FYEDress, Surgical1Product Code
- FYFCap, Surgical1Product Code
- FZKChair, Surgical, Non-Electrical1Product Code
- FZMStool, Operating-Room1Product Code
- FZOChisel, Surgical, Manual1Product Code
- FZPClip, Implantable2Product Code
- FZQClip, Removable (Skin)1Product Code
- FZRContractor, Surgical1Product Code
- FZSCurette, Surgical, General Use1Product Code
- FZTCutter, Surgical1Product Code
- FZWExpander, Surgical, Skin Graft1Product Code
- FZXGuide, Surgical, Instrument1Product Code
- FZYHammer, Surgical1Product Code
- FZZMarker, Skin1Product Code
- GAANeedle, Aspiration And Injection, Disposable1Product Code
- GABNeedle, Suturing, Disposable1Product Code
- GACRasp, Surgical, General & Plastic Surgery1Product Code
- GADRetractor1Product Code
- GAESnare, Surgical1Product Code
- GAFSpatula, Surgical, General & Plastic Surgery1Product Code
- GAHStylet, Surgical, General & Plastic Surgery1Product Code
- GAIStripper, Vein, Reusable1Product Code
- GAJStripper, Vein, Disposable1Product Code
- GAKSuture, Absorbable2Product Code
- GALSuture, Absorbable, Natural2Product Code
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid2Product Code
- GANSuture, Absorbable, Synthetic2Product Code
- GAOSuture, Nonabsorbable2Product Code
- GAPSuture, Nonabsorbable, Silk2Product Code
- GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile2Product Code
- GARSuture, Nonabsorbable, Synthetic, Polyamide2Product Code
- GASSuture, Nonabsorbable, Synthetic, Polyester2Product Code
- GATSuture, Nonabsorbable, Synthetic, Polyethylene2Product Code
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene2Product Code
- GBACatheter, Balloon Type1Product Code
- GBBChair, Surgical, Ac-Powered1Product Code
- GBCLamp, Surgical, Incandescent2Product Code
- GBNCatheter, Pediatric, General & Plastic Surgery1Product Code
- GBOCatheter, Nephrostomy, General & Plastic Surgery1Product Code
- GBPCatheter, Multiple Lumen1Product Code
- GBQCatheter, Continuous Irrigation1Product Code
- GBSCatheter, Ventricular, General & Plastic Surgery1Product Code
- GBWCatheter, Peritoneal1Product Code
- GBXCatheter, Irrigation1Product Code
- GBYCatheter, Eustachian, General & Plastic Surgery1Product Code
- GBZCatheter, Cholangiography1Product Code
- GCBNeedle, Catheter1Product Code
- GCCDilator, Catheter1Product Code
- GCDConnector, Catheter1Product Code
- GCEAdaptor, Catheter1Product Code
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered1Product Code
- GCZRetainer, Surgical1Product Code
- GDCTable, Operating-Room, Electrical1Product Code
- GDFGuide, Needle, Surgical1Product Code
- GDGHook, Surgical, General & Plastic Surgery1Product Code
- GDHGouge, Surgical, General & Plastic Surgery1Product Code
- GDIDissector, Surgical, General & Plastic Surgery1Product Code
- GDJClamp, Surgical, General & Plastic Surgery1Product Code
- GDLNeedle, Suturing, Reusable1Product Code
- GDMNeedle, Aspiration And Injection, Reusable1Product Code
- GDNKnife, Amputation1Product Code
- GDOApplier, Surgical, Clip1Product Code
- GDRSaw, Manual And Accessories1Product Code
- GDTStaple, Removable (Skin)1Product Code
- GDWStaple, Implantable2Product Code
- GDXScalpel, One-Piece1Product Code
- GDYGauze/Sponge, Internal, X-Ray Detectable1Product Code
- GDZHandle, Scalpel1Product Code
- GEACannula, Surgical, General & Plastic Surgery1Product Code
- GECBrush, Scrub, Operating-Room1Product Code
- GEDBrush, Dermabrasion, Manual1Product Code
- GEEBrush, Biopsy, General & Plastic Surgery1Product Code
- GEFApplier, Staple, Surgical,1Product Code
- GEGElevator, Surgical, General & Plastic Surgery1Product Code
- GEHUnit, Cryosurgical, Accessories2Product Code
- GEIElectrosurgical, Cutting & Coagulation & Accessories2Product Code
- GEJCarrier, Ligature1Product Code
- GENForceps, General & Plastic Surgery1Product Code
- GEOFile, Surgical, General & Plastic Surgery1Product Code
- GESBlade, Scalpel1Product Code
- GETMotor, Surgical Instrument, Pneumatic Powered1Product Code
- GEXPowered Laser Surgical Instrument2Product Code
- K220793InnoVoyce Laser Fiber2Cleared 510(K)
- K220381Diode Laser Therapy Systems2Cleared 510(K)
- K211534RevoLix HTL2Cleared 510(K)
- K220467The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories2Cleared 510(K)
- K220041HandPICO2Cleared 510(K)
- K213594ECHOLASER X42Cleared 510(K)
- K220189LISA Laser Surgical Fibers2Cleared 510(K)
- K213889PicoStar2Cleared 510(K)
- K210183Waterlase iPLus2Cleared 510(K)
- K213484SmoothCool HR System2Cleared 510(K)
- K213350mJOULE System and Accessories2Cleared 510(K)
- K210634MCL 31 Dermablate System2Cleared 510(K)
- K220103LED Therapy Device (Planar LED/Planar LED mini)2Cleared 510(K)
- K213557Finexel2Cleared 510(K)
- K211681EON2Cleared 510(K)
- K213461AviClear Laser System2Cleared 510(K)
- K220426Fiber Dust PRO2Cleared 510(K)
- K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares2Cleared 510(K)
- K220020Cryo 72Cleared 510(K)
- K213569HOLLYWOOD SPECTRA Laser System2Cleared 510(K)
- K213554Sentient Manufacturing Laser Fiber2Cleared 510(K)
- K211228Rosso2Cleared 510(K)
- K212611CO2 Laser Equipment2Cleared 510(K)
- K203395Platform treatment system2Cleared 510(K)
- K212478Dermatological diode laser system2Cleared 510(K)
- K212127Picocaremajesty2Cleared 510(K)
- K213225Diode Laser System GP900A8, Diode Laser System GP900Q82Cleared 510(K)
- K212492Frax 1940 for Nordlys and Frax Pro2Cleared 510(K)
- K202848S2 Pigment Removal System2Cleared 510(K)
- K210847UltraClear Fractional Laser System2Cleared 510(K)
- K212573PicoLO Premium2Cleared 510(K)
- K202175OxyLight 2.02Cleared 510(K)
- K202288Finebeam2Cleared 510(K)
- K212607Darwin2Cleared 510(K)
- K212978Diode laser therapy system2Cleared 510(K)
- K211517Optica 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 Accessorie2Cleared 510(K)
- K212502Resonic Rapid Acoustic Pulse Device2Cleared 510(K)
- K211977Medical Diode Laser Systems2Cleared 510(K)
- K202998Vydence Zye and Vydence One2Cleared 510(K)
- K212793Laser Treatment System, Model: Hera, Armo2Cleared 510(K)
- K211735CO2 Laser Machine, Model: BW-203B2Cleared 510(K)
- K212270DEKA LipoAI2Cleared 510(K)
- K212703AcuPulse CO2 Laser System, Delivery Devices and Accessories2Cleared 510(K)
- K201773PICOHI2Cleared 510(K)
- K212082Picore2Cleared 510(K)
- K203799ProFlex CO2 Laser Fiber2Cleared 510(K)
- K211637AROMA GRAND2Cleared 510(K)
- K210951Leonardo Mini Blue2Cleared 510(K)
- K211362SCAR 32Cleared 510(K)
- K211761UltraLase Flexible CO2 Laser Waveguide2Cleared 510(K)
- K211335Diode Laser Machine, Model Number: BM-1002Cleared 510(K)
- K203728Darwin2Cleared 510(K)
- K211821DEKA Motus AZ2Cleared 510(K)
- K203441The Alma Hybrid Laser System2Cleared 510(K)
- K202991Fotona XPulse Pro Laser Platform2Cleared 510(K)
- K202828Surgical Green Laser System2Cleared 510(K)
- K211401SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)2Cleared 510(K)
- K210535UltraLight LED System2Cleared 510(K)
- K210168Diode Laser Therapy Systems2Cleared 510(K)
- K210925Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber2Cleared 510(K)
- K210964Resonic Rapid Acoustic Pulse Device2Cleared 510(K)
- K210663Dermatological Diode Laser Systems2Cleared 510(K)
- K202258ERISE Laser handpiece2Cleared 510(K)
- K202257Dermatological Diode Laser Systems2Cleared 510(K)
- K202043Secret Duo2Cleared 510(K)
- K203491PicoLO Nd: YAG Picosecond Laser System2Cleared 510(K)
- K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable2Cleared 510(K)
- K210226PicoSure Workstation2Cleared 510(K)
- K203788DermaV Laser System2Cleared 510(K)
- K201466Tranberg CLS Laser Applicator2Cleared 510(K)
- K202985LightWalker Laser System Family2Cleared 510(K)
- K210142Fiber Dust2Cleared 510(K)
- K203054FlexSys2Cleared 510(K)
- K210033Laser Treatment System, Model: NYX and Grace2Cleared 510(K)
- K202702FLARE Single-Use Surgical Laser Fiber2Cleared 510(K)
- K203804Global Med Systems Milesman Compact Laser2Cleared 510(K)
- K201801Rapid Acoustic Pulse Device2Cleared 510(K)
- K193266MIIN2Cleared 510(K)
- K203241OmniGuide BeamPath OTO-U Fiber2Cleared 510(K)
- K203544UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories2Cleared 510(K)
- K201594Primelase Excellence2Cleared 510(K)
- K202601Single-use Sterile medical laser fiber2Cleared 510(K)
- K201687Avenda Health Treatment System2Cleared 510(K)
- K202250Dermatological Carbon Dioxide Laser Systems2Cleared 510(K)
- K202980Laser Therapy Device2Cleared 510(K)
- K202172StarWalker2Cleared 510(K)
- K200693K2 MOBILE2Cleared 510(K)
- K202503Chrome2Cleared 510(K)
- K202758Nd: YAG Laser Therapy Systems HM-YL9002Cleared 510(K)
- K202428AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories2Cleared 510(K)
- K202041Opera Evo2Cleared 510(K)
- K201056NeuroBlate System2Cleared 510(K)
- K201406Picowon2Cleared 510(K)
- K201663AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories2Cleared 510(K)
- K201109CO2 Laser Therapy System2Cleared 510(K)
- K201455Litho 150, Cyber Ho 1502Cleared 510(K)
- K200736Stardust Med2Cleared 510(K)
- K193477Nd: YAG Laser Therapy Systems2Cleared 510(K)
- K200786Venus Epileve2Cleared 510(K)
- K200042CO2 Laser System2Cleared 510(K)
- K200104Oxylight2Cleared 510(K)
- K200116PicoSecond Nd: YAG Laser System2Cleared 510(K)
- K200525Medical Diode Laser Hair Removal System2Cleared 510(K)
- K201111GentleMax Pro Plus2Cleared 510(K)
- K200751Photodynamic Therapy (PDT) Equipment2Cleared 510(K)
- K200659Dermalux Tri-Wave MD2Cleared 510(K)
- K192856MT One2Cleared 510(K)
- K200118Diode Laser Therapy Device2Cleared 510(K)
- K193464ND:YAG Laser2Cleared 510(K)
- K191970Diode Laser Hair Removal System2Cleared 510(K)
- K192735Diode Laser Hair Removal Machine2Cleared 510(K)
- K193656SkyPulse2Cleared 510(K)
- K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun2Cleared 510(K)
- K193661LightWalker Laser System Family2Cleared 510(K)
- K193609Q Switched Nd: YAG Laser machine2Cleared 510(K)
- K192272Wolf445nm2Cleared 510(K)
- K200110SANDRO Dual2Cleared 510(K)
- K193486Epic 9802Cleared 510(K)
- K192483MeDioStar2Cleared 510(K)
- K193367elysion-pro2Cleared 510(K)
- K200331Rapid Acoustic Pulse Device2Cleared 510(K)
- K193446Bare: 8082Cleared 510(K)
- K193426Elite iQ2Cleared 510(K)
- K200234Surgical laser fibers2Cleared 510(K)
- K192600Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 602Cleared 510(K)
- K192617Gemini 810+980 Soft Tissue Laser2Cleared 510(K)
- K192583PicoLazer Laser System2Cleared 510(K)
- K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser System2Cleared 510(K)
- K193478XTRAC Momentum Excimer Laser System2Cleared 510(K)
- K193375NeuroBlate System2Cleared 510(K)
- K191501PALLAS 308/311 Solid-State UV Laser System2Cleared 510(K)
- K192990Litho Evo2Cleared 510(K)
- K192755Soli-Lite LG4 Galileo2Cleared 510(K)
- K192539Deka Luxea2Cleared 510(K)
- K192569Diode Laser Therapy System2Cleared 510(K)
- K192516Diode Laser 808nm2Cleared 510(K)
- K191962Vitra 22Cleared 510(K)
- K192430Epic 9802Cleared 510(K)
- K192528CO2 Laser Therapy System2Cleared 510(K)
- K192269TwinScan 808/755 Laser System2Cleared 510(K)
- K192331LaseMD LEO Laser System2Cleared 510(K)
- K191693BC-52Cleared 510(K)
- K191942MT One Diamond2Cleared 510(K)
- K190319Waterlase Laser System Family2Cleared 510(K)
- K191842Discovery Pico, Discovery Pico Plus, Discovery Pico Derm2Cleared 510(K)
- K191685PicoWay Laser System2Cleared 510(K)
- K191518CO2 Laser System2Cleared 510(K)
- K181602Pioneer Elite Diode Laser2Cleared 510(K)
- K181614Sterling Supreme Diode Laser2Cleared 510(K)
- K181601Precise SHP Diode Laser2Cleared 510(K)
- K192160EVO Platform2Cleared 510(K)
- K183563Holinwon 302Cleared 510(K)
- K191554LightWalker Laser System Family2Cleared 510(K)
- K183122810nm Diode Laser System2Cleared 510(K)
- K191349980nm Diode Laser Therapy Device2Cleared 510(K)
- K183647SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)2Cleared 510(K)
- K191321Primelase Excellence2Cleared 510(K)
- K191611Diode Laser Therapy Systems2Cleared 510(K)
- K182930PerioLase Nd:YAG Pulsed Dental Laser System2Cleared 510(K)
- K191162EpiLaze Multi-wavelength Laser2Cleared 510(K)
- K190938Photodynamic Therapy System2Cleared 510(K)
- K190936Q-Switched Nd: YAG Laser System2Cleared 510(K)
- K183566CLARITY II Laser System2Cleared 510(K)
- K180511eon2Cleared 510(K)
- K190542Soliton Acoustic Wave Device2Cleared 510(K)
- K183199TRIO Handpiece2Cleared 510(K)
- K183156V-Laser2Cleared 510(K)
- K182924Diode Laser Treatment System2Cleared 510(K)
- K190392WaveLight FS200 Patient Interface2Cleared 510(K)
- K182173Joule System2Cleared 510(K)
- K190007Vydence Laser Family2Cleared 510(K)
- K183452Vbeam Prima Laser System2Cleared 510(K)
- K183392PicoLO Nd:YAG Picosecond Laser System2Cleared 510(K)
- K182045Lotus III Multi-Pulsed Er: Yag Laser System2Cleared 510(K)
- K182997enlighten III Laser System2Cleared 510(K)
- K183307Magma Spark Pro (Magma Spark Plus, Alpha)2Cleared 510(K)
- K182831SabreLine and SabreGuard Laser Fibers2Cleared 510(K)
- K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System2Cleared 510(K)
- K182604New Era2Cleared 510(K)
- K182270Cellene CO2 Laser System2Cleared 510(K)
- K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro2Cleared 510(K)
- K182669Youlaser CO22Cleared 510(K)
- K182036NeuroBlate System2Cleared 510(K)
- K181867Deka Smartxide2 Trio2Cleared 510(K)
- K181632Venacure 1470 Pro2Cleared 510(K)
- K173827LightScalpel2Cleared 510(K)
- K173676A-FIT2Cleared 510(K)
- K181662Iridex TruFocus LIO Premiere2Cleared 510(K)
- K181510ECHOLASER X42Cleared 510(K)
- K181486DEKA Motus AY2Cleared 510(K)
- K181480MMD Tip2Cleared 510(K)
- K181272Picocare Family2Cleared 510(K)
- K181431Laser Ureteral Catheter2Cleared 510(K)
- K180518GME LinScan Lite 808 Laser System2Cleared 510(K)
- K181019Diode Laser System2Cleared 510(K)
- K181523Syneron CO2RE System2Cleared 510(K)
- K180967Dental Diode Laser System2Cleared 510(K)
- K181044400um Perforator and Accessory Vein Ablation Kit2Cleared 510(K)
- K173359Fractional CO2 Surgical Laser System2Cleared 510(K)
- K180993Beacon Advanced CO2 Laser System2Cleared 510(K)
- K173700PICOPLUS Laser System2Cleared 510(K)
- K180719InMode Diolaze System2Cleared 510(K)
- K180593Vbeam Prima Laser System2Cleared 510(K)
- K180508JOULE SYSTEM2Cleared 510(K)
- K180922Empower H100, Cyber Ho 100, Litho 1002Cleared 510(K)
- K180140ProFlex Laser Fibers2Cleared 510(K)
- K171443Etherea MX2Cleared 510(K)
- K180353Diode laser hair removal device2Cleared 510(K)
- K180597AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO2Cleared 510(K)
- K180426Empower H352Cleared 510(K)
- K180423Empower H652Cleared 510(K)
- K180406Ellipse Ydun2Cleared 510(K)
- K180224ELEMENT-TL2Cleared 510(K)
- K180044SIROLaser Blue2Cleared 510(K)
- K180350Dornier Medilas H Solvo 35 Laser2Cleared 510(K)
- K172818LMT-30002Cleared 510(K)
- K173677InMode VLaze2Cleared 510(K)
- K173067LightForce LTS Model 1000, 1500, 2500, and 40002Cleared 510(K)
- K180193DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)2Cleared 510(K)
- K180158Surgical Laser fibers2Cleared 510(K)
- K172439Siberian Fit2Cleared 510(K)
- K173199PicoSure Workstation2Cleared 510(K)
- K173285JOULE SYSTEM2Cleared 510(K)
- K172193Modified 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 Modules2Cleared 510(K)
- K1730022940 nm Er:Yag Laser Handpiece2Cleared 510(K)
- K172908Q-Switched Nd:YAG Laser System2Cleared 510(K)
- K173038CuRAS Nd:YAG Laser2Cleared 510(K)
- K172819LightWalker Laser System Family2Cleared 510(K)
- K172771Epic Pro 9402Cleared 510(K)
- K173169Rapid Family2Cleared 510(K)
- K173305NeuroBlate System2Cleared 510(K)
- K172362DEKA SMARTXIDE TOUCH2Cleared 510(K)
- K172363DEKA SMARTXIDE ULTRASPEED2Cleared 510(K)
- K172639PALLAS 308/311 Solid-State UV Laser System2Cleared 510(K)
- K172077Cutera enlighten III Laser System2Cleared 510(K)
- K172325Rhapsody H-30 Holmium Laser System2Cleared 510(K)
- K172881NeuroBlate System2Cleared 510(K)
- K172376Discovery Pico, Discovery Pico Plus2Cleared 510(K)
- K1721985852Cleared 510(K)
- K172413MT ONE2Cleared 510(K)
- K171986Sterling Supreme Diode Laser2Cleared 510(K)
- K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity2Cleared 510(K)
- K170409PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System2Cleared 510(K)
- K171648BM.IRIS2Cleared 510(K)
- K170970Epilaser2Cleared 510(K)
- K171921VenaCure EVLT NeverTouch Procedure Kit2Cleared 510(K)
- K171227StarWalker2Cleared 510(K)
- K172096Fraxis2Cleared 510(K)
- K170060M22 and ResurFx Systems2Cleared 510(K)
- K170738InMode Diolaze XL2Cleared 510(K)
- K171079Q-Switched Nd:YAG Laser System2Cleared 510(K)
- K172025Litho 602Cleared 510(K)
- K171945Discovery Pico, Discovery Pico Plus2Cleared 510(K)
- K170187Photodynamic Therapy Device2Cleared 510(K)
- K171255Monteris Medical NeuroBlate System2Cleared 510(K)
- K170073LightMed Dental Laser System2Cleared 510(K)
- K171711Thunder, Thunder VT, Thunder HR2Cleared 510(K)
- K171009LASEMD Laser System2Cleared 510(K)
- K163449HyPHo Laser System2Cleared 510(K)
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- K170121Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories2Cleared 510(K)
- K160677MICRORUPTOR 62Cleared 510(K)
- K170500SIROLaser Advance+2Cleared 510(K)
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- K170734Venus Silk.expert2Cleared 510(K)
- K170718Iridex TruFocus LIO Premiere2Cleared 510(K)
- K162334U.S. Laser Worx Patriot 1 family of lasers2Cleared 510(K)
- K170936Cutera enlighten III Laser System2Cleared 510(K)
- K170215LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock2Cleared 510(K)
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- K160549MEDICAL DIODE LASER SYSTEMS2Cleared 510(K)
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- K163655Sparkling2Cleared 510(K)
- K170331Cyber Ho2Cleared 510(K)
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- K162765Venus Velocity Diode Laser System2Cleared 510(K)
- K162114Photon, Photon Plus2Cleared 510(K)
- K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)2Cleared 510(K)
- K163222Discovery Pico Family2Cleared 510(K)
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- K161670Lucid Q-PTP / HWA 552Cleared 510(K)
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- K160312FRAXIS DUO2Cleared 510(K)
- K162169EdgeOne CO2 Laser2Cleared 510(K)
- K162762NeuroBlate System2Cleared 510(K)
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- K161925CO2 Laser Therapy Machine2Cleared 510(K)
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- K160413Sterling 5W Diode Laser2Cleared 510(K)
- K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra2Cleared 510(K)
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- K161503ORION2Cleared 510(K)
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- K161771Medilas H Laser Fibers2Cleared 510(K)
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- K142093V20 SYSTEM2Cleared 510(K)
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- K140470OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER2Cleared 510(K)
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- K123483DIODE LASER2Cleared 510(K)
- K123573YOULASER CO2 LASER2Cleared 510(K)
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- K113390LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500)2Cleared 510(K)
- K112600ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT2Cleared 510(K)
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- K113792MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE2Cleared 510(K)
- K112013EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER2Cleared 510(K)
- K113140VARI-LASE WIREFIBER LASER FIBER2Cleared 510(K)
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- K103455SPECTRA LASER SYSTEM2Cleared 510(K)
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- K110434TRIXEL CO2 LASER2Cleared 510(K)
- K110304APEX ER. YAG / IPL SYSTEM2Cleared 510(K)
- K103654VELA XL2Cleared 510(K)
- K110685FLEXIVA TRACTIP2Cleared 510(K)
- K110686ACCUTRAC2Cleared 510(K)
- K101916JOULE MULTI-PLATFORM SYSTEM2Cleared 510(K)
- K110080RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM2Cleared 510(K)
- K103753SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER2Cleared 510(K)
- K110079SPPHINE PLUS STM 3W DIODE LASER2Cleared 510(K)
- K103288DEKA SYNCHRO FT2Cleared 510(K)
- K103539QUANTA SYSTEM DUOLITE2Cleared 510(K)
- K103501ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES2Cleared 510(K)
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- K060787TATTOOSTAR FAMILY2Cleared 510(K)
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- K061618COOLTOUCH, MODEL CTEV2Cleared 510(K)
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- K062048AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM2Cleared 510(K)
- K053540INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE2Cleared 510(K)
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- K060326LASERTX - DIODE LASER & DELIVERY SYSTEM2Cleared 510(K)
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- K053511DA VINCI FEMTOSECOND SURGICAL LASER2Cleared 510(K)
- K060338FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO2Cleared 510(K)
- K060069PALOMAR LUXIR FRACTIONAL HANDPIECE2Cleared 510(K)
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- K053421YAG MIR FAMILY LASER2Cleared 510(K)
- K052991RADIANCY FACIAL SKINCARE DEVICE2Cleared 510(K)
- K052442RADIANCY SKINSTATION WITH PSORIASIS LIGHT UNIT ASSEMBLY2Cleared 510(K)
- K060050MEGABEAM SIDEFIBER FIBER OPTIC DELIVERY SYSTEM2Cleared 510(K)
- K052680CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES2Cleared 510(K)
- K053161SIROLASER2Cleared 510(K)
- K053324CHROMOLITE SYSTEM2Cleared 510(K)
- K051113QUANTA SYSTEM ETRNA GIOVINEZZA2Cleared 510(K)
- K052848SPECTRA HAIR REMOVAL LASER2Cleared 510(K)
- K053457VAPORMAX II2Cleared 510(K)
- K052604STARLITE 20062Cleared 510(K)
- K052688ELLIPSE FLEX PPT, MODEL 9ESF72552Cleared 510(K)
- K052874SOPRANO HAIR REMOVAL DIODE LASER2Cleared 510(K)
- K052526NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES2Cleared 510(K)
- K052806BURANE2Cleared 510(K)
- K052495ATRILAZE MALLEABLE ABLATION PROBE2Cleared 510(K)
- K052336SPECTRAQUATTRO PULSED LIGHT SYSTEM2Cleared 510(K)
- K051508MED FLASH II INTENSE PULSED LIGHT SYSTEM.2Cleared 510(K)
- K051259VERSACLEAR SKIN THERAPY SYSTEM, MODEL 1002Cleared 510(K)
- K052324POLARIS LV, LVA APPLICATOR2Cleared 510(K)
- K050382AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM2Cleared 510(K)
- K051876MULTIWAVE XR2Cleared 510(K)
- K051671RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY2Cleared 510(K)
- K052129LUMENIS 1000 INTEGRATED SLIT LAMP2Cleared 510(K)
- K051996DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 302Cleared 510(K)
- K050824100W CERALAS D 980 LASER SYSTEM, MODEL D1002Cleared 510(K)
- K051434COOLTOUCH ND:YAG LASER SYSTEMS, MODELS CT3S AND CTEV2Cleared 510(K)
- K051428VTRAC EXCIMER LAMP SYSTEM2Cleared 510(K)
- K050216OMNILUX REVIVE AND OMNILUX PLUS2Cleared 510(K)
- K051287VARI-LASE ENDOVENOUS LASER PROCEDURE KIT2Cleared 510(K)
- K041893INTRALASE FS LASER2Cleared 510(K)
- K043032DEALIGHT IPL2Cleared 510(K)
- K051359CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY2Cleared 510(K)
- K051268RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT2Cleared 510(K)
- K050841FRAXEL SR LASER SYSTEM2Cleared 510(K)
- K051255LUMIPHASE-R2Cleared 510(K)
- K051399WAVELIGHT AURIGA2Cleared 510(K)
- K050779CYNERGY MULTIPLEX LASER2Cleared 510(K)
- K042630REVLIGHT SKIN CARE SYSTEM2Cleared 510(K)
- K050696MEDLITE C1 Q-SWITCHED ND:YAG LASER2Cleared 510(K)
- K050673CANDELA FAMILY OF PULSE DYE LASER SYSTEMS2Cleared 510(K)
- K050738FT FIBER OPTIC DELIVERY SYSTEMS2Cleared 510(K)
- K051167REVOLIX AND REVOLIX JR2Cleared 510(K)
- K043377ZENO2Cleared 510(K)
- K050453ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-000502Cleared 510(K)
- K050900MEDIOSTAR XT2Cleared 510(K)
- K050672ERCHONIA EVRL LASER2Cleared 510(K)
- K050950MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS2Cleared 510(K)
- K050274DIODENT II DENTAL LASER SYSTEM2Cleared 510(K)
- K041554AIP INTENSE PULSED LIGHT SYSTEM2Cleared 510(K)
- K050165MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C1002Cleared 510(K)
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- K050562OCULIGHT GL/GLX2Cleared 510(K)
- K050796AURORA DS, DS APPLICATOR2Cleared 510(K)
- K050679CUTERA SOLERA OPUS AESTHETIC PRODUCT2Cleared 510(K)
- K050047CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY2Cleared 510(K)
- K043521BIOSYAG 50 MED2Cleared 510(K)
- K050293FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS2Cleared 510(K)
- K050021VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT2Cleared 510(K)
- K043329OMNILUX REVIVE AND BLUE2Cleared 510(K)
- K050412VAPORMAX2Cleared 510(K)
- K050108SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS2Cleared 510(K)
- K042319RELIANT LASER II SYSTEM AND ACCESSORIES2Cleared 510(K)
- K050452AURORA SR AND SRA APPLICATOR2Cleared 510(K)
- K043486PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-012Cleared 510(K)
- K050317BURANE XL2Cleared 510(K)
- K043575DERMILLUME, MODEL PRO10002Cleared 510(K)
- K043255ELLIPSE LIGHT SPT2Cleared 510(K)
- K050218WAVELIGHT SINON2Cleared 510(K)
- K043251CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B2Cleared 510(K)
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- K041086PALOMAR STARLUX PULSED LIGHT SYSTEM2Cleared 510(K)
- K043429CYNERGY LASER2Cleared 510(K)
- K042000MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS2Cleared 510(K)
- K043319CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES2Cleared 510(K)
- K040270OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM2Cleared 510(K)
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- K040744ATRILAZE SOFT TISSUE ABLATION SYSTEM2Cleared 510(K)
- K042968MCL 30 DERMABLATE ER:YAG LASER SYSTEM2Cleared 510(K)
- K042918MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E22Cleared 510(K)
- K041242CANDELA SMOOTHBEAM LASER SYSTEM2Cleared 510(K)
- K043012OMNIPULSE MINI, MODEL 21202Cleared 510(K)
- K041323PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA2Cleared 510(K)
- K042211MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS2Cleared 510(K)
- K041959POLARIS DS/COMET2Cleared 510(K)
- K042496ADEPT ULTRALITE 532 LASER2Cleared 510(K)
- K041969AURORA DS2Cleared 510(K)
- K041943XTRAC XL, MODEL AL80002Cleared 510(K)
- K040563LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT)2Cleared 510(K)
- K042439AZURYT MODEL CLT 1401, CO2 SURGICAL LASER SYSTEM2Cleared 510(K)
- K041994MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K041767COOLCUBE COOLPEN2Cleared 510(K)
- K042474ARION2Cleared 510(K)
- K041739EDWARDS E360 SURGICAL ABLATION DEVICE2Cleared 510(K)
- K040921COOLTOUCH, MODEL NS 1602Cleared 510(K)
- K032991LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX2Cleared 510(K)
- K041930VARILITE LASER SYSTEM2Cleared 510(K)
- K042139VISULAS YAG III2Cleared 510(K)
- K041660TRIMEDYNE HOLMIUM LASER SYSTEMS2Cleared 510(K)
- K041829FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS2Cleared 510(K)
- K041419LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM2Cleared 510(K)
- K041262DURALITE-GL2Cleared 510(K)
- K041721LVI AESTHETIC LASER2Cleared 510(K)
- K041710VERSAWAVE DENTAL ER:YAG LASER SYSTEM2Cleared 510(K)
- K041103ACNELIFT2Cleared 510(K)
- K030290PERIOLASE ND:YAG DENTAL LASER SYSTEM2Cleared 510(K)
- K031140WATERLASE2Cleared 510(K)
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- K040617RELIANT LASER SYSTEM II2Cleared 510(K)
- K040659MCCUE PLC ENERGIST ULTRA VARIABLE PULSED LIGHT SYSTEM2Cleared 510(K)
- K032397DUAL YELLOW LASER, MODEL DUAL YELLOW D10B2Cleared 510(K)
- K041095PHOTOSILK PULSED LIGHT SYSTEM2Cleared 510(K)
- K040433SINON2Cleared 510(K)
- K040384MYDON C2Cleared 510(K)
- K040424LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 11202Cleared 510(K)
- K040294LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 9802Cleared 510(K)
- K030810COOLAN 3002Cleared 510(K)
- K040289SMARTLITE D FREQUENCY DOUBLED ND:YAG LASER2Cleared 510(K)
- K040727CRYO 52Cleared 510(K)
- K040131COOLTOUCH; COOLTOUCH II; AND COOLTOUCH CT3 ND:YAG LASER SYSTEM2Cleared 510(K)
- K033183RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM00122Cleared 510(K)
- K040055POLYLASE LP2Cleared 510(K)
- K032797DELIGHT DENTAL ER: YAG LASER SYSTEM2Cleared 510(K)
- K040234LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM2Cleared 510(K)
- K040081PALOMAR LUXV HANDPIECE2Cleared 510(K)
- K033072LUCENTLITE, MODEL IMD 0102Cleared 510(K)
- K034011GEMINI SURGICAL LASER SYSTEM & ACCESSORIES2Cleared 510(K)
- K040005PROFILE 2000/3000 LASER SYSTEM2Cleared 510(K)
- K040156IFL PROFESSIONAL SYSTEM, MODEL C1002Cleared 510(K)
- K032863CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D502Cleared 510(K)
- K032864CERALAS D 810 DIODE LASER SYSTEM, MODEL D152Cleared 510(K)
- K033933POWERLITE 600 EX SYSTEM2Cleared 510(K)
- K033549STARLUX PULSED LIGHT SYSTEM2Cleared 510(K)
- K032459PROFILE 1320 LASER SYSTEM2Cleared 510(K)
- K033251THE FRIENDLYLIGHT ND: YAG LASERS2Cleared 510(K)
- K033259LIGHT AGE Q-CLEAR LASER, MODEL 701-11012Cleared 510(K)
- K033962LAD (EPITURE EASYTOUCH), MODEL LAD-082Cleared 510(K)
- K033354FEMTEC LASER MICROKERATOME2Cleared 510(K)
- K034030APOGEE ELITE2Cleared 510(K)
- K030523WATERLASE2Cleared 510(K)
- K032514AC APPLICATOR, AURORA AC2Cleared 510(K)
- K032667FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW)2Cleared 510(K)
- K033176TRISTAR AESTHETIC WORKSTATION LASER2Cleared 510(K)
- K033437SPHINX LASER SYSTEMS2Cleared 510(K)
- K033461CANDELA VBEAM PULSE DYE LASER SYSTEM2Cleared 510(K)
- K033331CANDELA CBEAM PULSE DYE LASER SYSTEM2Cleared 510(K)
- K033423REVOLIX LASER SYSTEMS2Cleared 510(K)
- K033799CLINICAL LASETTE P-2002Cleared 510(K)
- K032944YA-MAN LASER 212Cleared 510(K)
- K032846SPECTRA PULSED DIODE LASER, MODEL DR-12Cleared 510(K)
- K032205RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY2Cleared 510(K)
- K033586MODIFICATION TO AURORA DS2Cleared 510(K)
- K032735SPECTRA QT: Q-SWITCHED ND: YAG LASER SYSTEM2Cleared 510(K)
- K030834CANDELA SMOOTHBEAM LASER SYSTEM2Cleared 510(K)
- K031671POLARIS WR2Cleared 510(K)
- K032383MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K033237VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE2Cleared 510(K)
- K032260ARAMIS II DERMATOLOGICAL LASER2Cleared 510(K)
- K032539CYNOSURE PHOTOGENICA SV LASER2Cleared 510(K)
- K024206AURA ISURGICAL LASER SYSTEM & ACCESSORIES2Cleared 510(K)
- K032460PROFILE BBL SYSTEM2Cleared 510(K)
- K031795RELIANT LASER SYSTEM2Cleared 510(K)
- K033172CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS2Cleared 510(K)
- K031819DIO-DENT 10 DENTAL DIODE LASER2Cleared 510(K)
- K032599MEDICAL LASER TECHNOLOGIES, LLC MTL ERBIUM:YAG LASER SYSTEM2Cleared 510(K)
- K033181SPR SYSTEM2Cleared 510(K)
- K032704INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-302Cleared 510(K)
- K032703INNOVATECH STRAIGHT LASER PROBE, MODEL 420-102Cleared 510(K)
- K032221ADEPT 1064/755 LASER2Cleared 510(K)
- K032220ADEPT 1064/532 LASER2Cleared 510(K)
- K032218ADEPT 1064/532/755 LASER2Cleared 510(K)
- K032565CYNOSURE PHOTOGENICA VL2Cleared 510(K)
- K030539LASERSMILE2Cleared 510(K)
- K032357NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES2Cleared 510(K)
- K031125CYNOSURE SMART FILE ND:YAG LASERS2Cleared 510(K)
- K032085GREEN LASER PHOTOCOAGULATOR MODEL GYC-10002Cleared 510(K)
- K032805MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT2Cleared 510(K)
- K032023W.O.M. LASER U100PLUS2Cleared 510(K)
- K031440SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER2Cleared 510(K)
- K031389CYNOSURE SMART 2940D ER:YAG LASER2Cleared 510(K)
- K031960INTRALASE FS LASER2Cleared 510(K)
- K030846CANDELA SMOOTHBEAM LASER SYSTEM2Cleared 510(K)
- K031805BLU-U, MODEL 41702Cleared 510(K)
- K031954COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS2Cleared 510(K)
- K032204MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT2Cleared 510(K)
- K032191OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM2Cleared 510(K)
- K031489PITANGA2Cleared 510(K)
- K031988AURORA DS2Cleared 510(K)
- K031993AURORA SR2Cleared 510(K)
- K031451XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL70002Cleared 510(K)
- K030033LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES2Cleared 510(K)
- K030426OMNILUX RED2Cleared 510(K)
- K030342LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS2Cleared 510(K)
- K031690CYNOSURE YAG FAMILY LASER (PHOTOGENICA YAG AND ACCLAIM)2Cleared 510(K)
- K031258CYNOSURE PHOTOLIGHT PL2Cleared 510(K)
- K024204FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM2Cleared 510(K)
- K031680SPECTRAPULSE2Cleared 510(K)
- K024259PULSED LIGHT THERAPY SYSTEM, MODEL# UV-3002Cleared 510(K)
- K024189NLITE SYSTEM, MODEL#: A00-1025/A00-10332Cleared 510(K)
- K030897SKINSTATION2Cleared 510(K)
- K024093MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS2Cleared 510(K)
- K031233ANDIODYNAMICS, INC. ELVS PROCEDURE KIT2Cleared 510(K)
- K030883OMNILUX BLUE2Cleared 510(K)
- K030654VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT2Cleared 510(K)
- K023881PROFILE 1064 LASER SYSTEM2Cleared 510(K)
- K031488CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASER2Cleared 510(K)
- K030700CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT2Cleared 510(K)
- K031317SMART 2940 D ER: YAG LASER2Cleared 510(K)
- K031184COOL TOUCH 32Cleared 510(K)
- K030805MYTHOS 5002Cleared 510(K)
- K030527LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS2Cleared 510(K)
- K030508DEPILASE TRIO LASE LASER SYSTEM2Cleared 510(K)
- K030510DEPILASE TWIN YAG LASER SYSTEM2Cleared 510(K)
- K030480L600 HAIR REMOVAL2Cleared 510(K)
- K030453COOLTOUCH ND: YAG LASER SYSTEM2Cleared 510(K)
- K031224SMARTXIDE2Cleared 510(K)
- K030506DEPILASE YAG LASE PLUS LASER SYSTEM2Cleared 510(K)
- K030423POWERLITE 600 EP SYSTEM2Cleared 510(K)
- K023734ARAMIS II DERMATOLOGICAL LASER2Cleared 510(K)
- K030959BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-1002Cleared 510(K)
- K030235F1 DIODE LASER SYSTEM2Cleared 510(K)
- K030181INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM2Cleared 510(K)
- K030147LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS2Cleared 510(K)
- K023547DIOLASE 980 D LASER SYSTEM2Cleared 510(K)
- K030186POLRIS LV2Cleared 510(K)
- K024371CANDELA GENTLE LASE FAMILY OF LASER SYSTEM2Cleared 510(K)
- K023257ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX2Cleared 510(K)
- K024260CANDELA GENTLELASE FAMILY OF LASER SYSTEMS2Cleared 510(K)
- K023954ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES2Cleared 510(K)
- K022923CANDELA GENTLE YAG LASER SYSTEM2Cleared 510(K)
- K024335CANDELA GENTLELASE FAMILY OF LASER SYSTEMS2Cleared 510(K)
- K024061PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.002Cleared 510(K)
- K023899DUAL YELLOW LASER, MODEL D10B2Cleared 510(K)
- K022709MEDLITE Q-SWITHCED LASER2Cleared 510(K)
- K030338ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM00022Cleared 510(K)
- K024064POLARIS DS2Cleared 510(K)
- K022807MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA2Cleared 510(K)
- K023967PALOMAR Q-YAG ND:YAG LASER SYSTEM2Cleared 510(K)
- K023624SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-69212Cleared 510(K)
- K022951CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG2Cleared 510(K)
- K022341TERABYTE 2000 HAIR REMOVER2Cleared 510(K)
- K022884CANDELA SMOOTHBEAM LASER SYSTEM2Cleared 510(K)
- K023464VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR2Cleared 510(K)
- K021222LAD, MODEL LAD-012Cleared 510(K)
- K024088CERALAS D 980 LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT, MODEL: D15 AND D252Cleared 510(K)
- K022466PROFILE 1320 LASER SYSTEM2Cleared 510(K)
- K023962NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-1602Cleared 510(K)
- K023193CANDELA GENTLE YAG LASER SYSTEM2Cleared 510(K)
- K022607SPECTRAPULSE2Cleared 510(K)
- K023081PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION)2Cleared 510(K)
- K023041W.O.M. LASER U1002Cleared 510(K)
- K021548FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM2Cleared 510(K)
- K023543EVLT KIT AND D15PLUS AND D30PLUS DIODE2Cleared 510(K)
- K022839FOTONA DUALIS PLUS ND:YAG LASER SYSTEM2Cleared 510(K)
- K022837FOTONA TANDEM LASER SYSTEM2Cleared 510(K)
- K022838FOTONA DUALIS ER:YAG/KTP LASER SYSTEM2Cleared 510(K)
- K022817COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II2Cleared 510(K)
- K022464EQUILASE SYSTEM2Cleared 510(K)
- K021444CYNOSURE PHOTOGENICA SV2Cleared 510(K)
- K022760MILLENNIUM MICROSURGICAL SYSTEM2Cleared 510(K)
- K022655TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH2Cleared 510(K)
- K022610CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 11602Cleared 510(K)
- K022583FLASH 12Cleared 510(K)
- K022060LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE ACCESSORIES2Cleared 510(K)
- K020339DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEM2Cleared 510(K)
- K023182INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS2Cleared 510(K)
- K022381PROFILE 1320 LASER SYSTEM2Cleared 510(K)
- K022378PLASMALITE PULSED LIGHT SYSTEM2Cleared 510(K)
- K022351DIODENT DENTAL LASER SYSTEM2Cleared 510(K)
- K022338OPTICAL INTEGRITY GENERAL SHAPED FIBER2Cleared 510(K)
- K022327NOVUS SPECTRA2Cleared 510(K)
- K020839QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, VX, DL2Cleared 510(K)
- K022228FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES2Cleared 510(K)
- K022226ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS2Cleared 510(K)
- K014128CANDELA SMOOTHBEAM LASER SYSTEM2Cleared 510(K)
- K022266AURORA SR2Cleared 510(K)
- K022181NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES2Cleared 510(K)
- K013974RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A2Cleared 510(K)
- K021975LASERSYSTEM BEAUTYSTAR 5322Cleared 510(K)
- K021946CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEM2Cleared 510(K)
- K021848CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, 11602Cleared 510(K)
- K022568PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIR2Cleared 510(K)
- K022569PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONS2Cleared 510(K)
- K022544DORNIER MEDILAS H LASER FIBER CABLES2Cleared 510(K)
- K02169620G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF252Cleared 510(K)
- K021686LASER FIBER GF5002Cleared 510(K)
- K021724DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS2Cleared 510(K)
- K021650ATHOSCAN FOR THE ATHOS LASER CONSTANS COOLING HAND PIECE FOR THE ATHOS LASER2Cleared 510(K)
- K013623CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 4202Cleared 510(K)
- K013691CERALAS D DIODE LASER SYSTEM, MODEL # D502Cleared 510(K)
- K021550LUMENIS SELECTA DUET2Cleared 510(K)
- K021508OPUSDUO EC DENTAL LASER SYSTEM2Cleared 510(K)
- K021304PROLITE PULSED LIGHT SYSTEM2Cleared 510(K)
- K021616DELIGHT DENTAL ER: YAG LASER SYSTEM2Cleared 510(K)
- K021149AURORA DS2Cleared 510(K)
- K021180CANDELA VBEAM PULSED DYE LASER SYSTEM2Cleared 510(K)
- K020021LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION)2Cleared 510(K)
- K021227SOFTLASE G2-SURGICAL DIODE LASER SYSTEM2Cleared 510(K)
- K020958CANDELA CBEAM PULSED DYE LASER SYSTEM2Cleared 510(K)
- K020941PALOMAR LUXG HANDPIECE2Cleared 510(K)
- K020856SPATOUCH PHOTOEPILATION SYSTEM2Cleared 510(K)
- K020835CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-602Cleared 510(K)
- K020729NLITE SYSTEM,MODEL A00-10512Cleared 510(K)
- K014040FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS2Cleared 510(K)
- K020673WAVE FORM MANUFACTURING PROLASE GENERAL SHAPED FIBER2Cleared 510(K)
- K013021LIGHTLANCE LASER SKIN PERFORATOR2Cleared 510(K)
- K020849APEX 800 LASER SYSTEM, MODEL APEX 8002Cleared 510(K)
- K020847XTRAC EXCIMER LASER SYSTEM, MODEL AL70002Cleared 510(K)
- K020513EPY-502Cleared 510(K)
- K020453PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER2Cleared 510(K)
- K013300MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM2Cleared 510(K)
- K020697DEPILASE TWIN YAG LASER SYSTEM2Cleared 510(K)
- K020099MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE2Cleared 510(K)
- K020072ATHOS LASER2Cleared 510(K)
- K020071VIRIDIS DERMA LASER2Cleared 510(K)
- K020973EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO2Cleared 510(K)
- K014272PERIOLASE ND:YAG DENTAL LASER SYSTEM2Cleared 510(K)
- K014253DERMACHILLER 42Cleared 510(K)
- K014236CLINICON WAVEGUIDE PLATFORM WITH INTERCONNECT FOR LUXAR ACCESSORIES2Cleared 510(K)
- K013201CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR2Cleared 510(K)
- K014057DERMASTAR ER:YAG LASER SYSTEM2Cleared 510(K)
- K014035COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS2Cleared 510(K)
- K020463DEPILASE YAG LASE PLUS LASER SYSTEM2Cleared 510(K)
- K013941PULSION FS LASER KERATOME2Cleared 510(K)
- K013216DIODENT DENTAL LASER SYSTEM2Cleared 510(K)
- K013940LASER SYSTEM YELLOWSTAR2Cleared 510(K)
- K020412DEPILASE TWIN LASE LASER SYSTEM2Cleared 510(K)
- K013825CANDELA SMOOTHBEAM LASER SYSTEM2Cleared 510(K)
- K014048CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS2Cleared 510(K)
- K013748CANDELA SCLERO LONG PULSE LASER (AKA VBEAM)2Cleared 510(K)
- K013864MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-602Cleared 510(K)
- K020107SMARTEPIL2Cleared 510(K)
- K012398DIOMED 15 DIODE LASER2Cleared 510(K)
- K014234MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER2Cleared 510(K)
- K013461NLITE SYSTEM,MODEL A00-10252Cleared 510(K)
- K014130NLITE SYSTEM2Cleared 510(K)
- K014100OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND2Cleared 510(K)
- K013365PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS2Cleared 510(K)
- K013366PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR2Cleared 510(K)
- K011939FOTONA DUALIS, FOTONA DUALIS PLUS2Cleared 510(K)
- K013193MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE2Cleared 510(K)
- K011960LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S4)2Cleared 510(K)
- K013901MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM)2Cleared 510(K)
- K013493INDIGO OPTIMA LASER SYSTEM2Cleared 510(K)
- K013028PALOMAR SLP 10002Cleared 510(K)
- K013047FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM2Cleared 510(K)
- K012071ENT LASERVISION2Cleared 510(K)
- K010771PERIOLASE ND:YAG DENTAL LASER SYSTEM2Cleared 510(K)
- K012806CYNOSURE PHOTOGENICA VL2Cleared 510(K)
- K011322DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE2Cleared 510(K)
- K013499DIOMED 15 PLUS AND DIOMED 30PLUS LASERS2Cleared 510(K)
- K012790CYNOSURE PHOTOGENICA ER2Cleared 510(K)
- K013402VISULAS 532S2Cleared 510(K)
- K012682REPROCESSED LASER PROBE2Cleared 510(K)
- K011174PARADIGM-FONTONA PEROVSKITE ND: YAP LASER SYSTEM AND ACCESSORIES2Cleared 510(K)
- K011070DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR2Cleared 510(K)
- K012552SCITON IMAGE HAIR REMOVAL LASER2Cleared 510(K)
- K012545ARAMIS DERMATLOGIC LASER2Cleared 510(K)
- K011175W.O.M. LASER U1002Cleared 510(K)
- K013043CANDELA CLEARBEAM PULSED DYE LASER2Cleared 510(K)
- K011021LASER 202Cleared 510(K)
- K012127PULSEMASTER ERBIUM DENTAL LASER SYSTEM2Cleared 510(K)
- K010804MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS2Cleared 510(K)
- K010715AL-402Cleared 510(K)
- K012982COOLTOUCH VARIZOOM2Cleared 510(K)
- K010618PALOMAR DERMALUX PULSED LIGHT SYSTEM2Cleared 510(K)
- K011828CYNOSURE ACCLAIM DERMATOLOGY LASER2Cleared 510(K)
- K011769OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND2Cleared 510(K)
- K011747PALOMAR LC 100 DIODE LASER2Cleared 510(K)
- K011703LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES2Cleared 510(K)
- K002890INTRALASE 600C LASER KERATOME2Cleared 510(K)
- K011423INPULSE DENTAL LASER2Cleared 510(K)
- K011382XTRAC EXCIMER LASER SYSTEM, MODEL AL 70002Cleared 510(K)
- K011207LASER PERIPHERALS REUSABLE HOLMIUM FIBER2Cleared 510(K)
- K011092CANDELA SPTL-1E PULSED DYE LASER2Cleared 510(K)
- K011041WATERLASE, MILLENNIUM2Cleared 510(K)
- K011677MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER2Cleared 510(K)
- K010927MODIFICATION TO PROLITE PULSED LIGHT SYSTEM2Cleared 510(K)
- K010928PROLITE VL PULSED LIGHT SYSTEM2Cleared 510(K)
- K011409SLT LASERPRO CTH HOLMIUM LASER SYSTEM2Cleared 510(K)
- K010885UNI-LASER 4702Cleared 510(K)
- K010580PALOMAR SLP 10002Cleared 510(K)
- K003318PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X2Cleared 510(K)
- K010834LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES2Cleared 510(K)
- K010689MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM2Cleared 510(K)
- K010316COOLTOUCH VARIA ND:YAG LASER SYSTEM; COOLTOUCH VARIA-II ND:YAG LASER SYSTEM2Cleared 510(K)
- K010284LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)2Cleared 510(K)
- K003440SOFTLASE - SURGICAL DIODE LASER SYSTEM2Cleared 510(K)
- K010113LASER MECHANISMS LASER SCANNING SYSTEM2Cleared 510(K)
- K010104CANDELA LONG PULSE ND:YAG2Cleared 510(K)
- K010046NUVOLASE 532 MEDICAL LASER SYSTEM2Cleared 510(K)
- K010005CYNOSURE PHOTOGENICA DL2Cleared 510(K)
- K004039CYNOSURE PHOTOGENICA NEO-V2Cleared 510(K)
- K004021F1 DIODE LASER SYSTEM2Cleared 510(K)
- K003993DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE)2Cleared 510(K)
- K004006SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER2Cleared 510(K)
- K004014MD 30 COMPACT2Cleared 510(K)
- K003953INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF0012Cleared 510(K)
- K003952INDIGO LASEROPTIC TREATMENT SYSTEM2Cleared 510(K)
- K003955LASEREX INTEGRE, MODEL LP25322Cleared 510(K)
- K003614LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM2Cleared 510(K)
- K010041SLT DIFFUSER FIBER2Cleared 510(K)
- K003765LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)2Cleared 510(K)
- K010285CONTOUR PROFILE LASER2Cleared 510(K)
- K003886PALOMAR SPALIGHT PULSED LIGHT SYSTEM2Cleared 510(K)
- K003705XTRAC EXCIMER LASER SYSTEM, MODEL AL70002Cleared 510(K)
- K003715COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH II2Cleared 510(K)
- K003885VISULAS YAG II2Cleared 510(K)
- K003541DENLASER, MODEL 8002Cleared 510(K)
- K003460PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM2Cleared 510(K)
- K003385TWILITE, TWILITE WHITE2Cleared 510(K)
- K003202FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II2Cleared 510(K)
- K003151MICROPOBE SERIES OF LASERS AND ACCESSORIES2Cleared 510(K)
- K003781COOLTOUCH VARIA-II ND:YAG LASER SYSTEM2Cleared 510(K)
- K002308OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A2Cleared 510(K)
- K003147LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION)2Cleared 510(K)
- K002899OPUS 20, MODEL 1ST2Cleared 510(K)
- K002884PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES2Cleared 510(K)
- K002853SCITON IMAGE HAIR REMOVAL LASER2Cleared 510(K)
- K001211MODIFICATION TO INTRALASE 600C LASER KERATOME2Cleared 510(K)
- K003046IMAGE VASCULAR LASER2Cleared 510(K)
- K002649ARAMIS DERMATOLOGICAL LASER2Cleared 510(K)
- K000023FRIENDLY LIGHT ER:YAG PULSED LASER2Cleared 510(K)
- K002421CANDELA MID IR DIODE LASER SYSTEM2Cleared 510(K)
- K001676OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A2Cleared 510(K)
- K000317SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM2Cleared 510(K)
- K001990DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES2Cleared 510(K)
- K000929PROLITE PULSED LIGHT SYSTEM2Cleared 510(K)
- K002228PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X2Cleared 510(K)
- K002296CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G152Cleared 510(K)
- K001093CANDELA SPTL-1B PULSED DYE LASER2Cleared 510(K)
- K000727BUFFLIGHT CLT SURGICAL LASER SYSTEM2Cleared 510(K)
- K002072PROLITE VL PULSED LIGHT SYSTEM2Cleared 510(K)
- K002032C02 LASER MULTIPULSE2Cleared 510(K)
- K001784VIRIDIS LASER2Cleared 510(K)
- K001704ATHOS2Cleared 510(K)
- K000811NLITE SYSTEM, SLS MODEL NUMBER A00-10252Cleared 510(K)
- K000158VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B92Cleared 510(K)
- K001589CANDELA DYNAMIC COOLING DEVICE2Cleared 510(K)
- K002347COOLTOUCH II2Cleared 510(K)
- K001975CERALAS D10 810NM LASER, MODEL CERALAS D10-602Cleared 510(K)
- K001527FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES2Cleared 510(K)
- K990119EPI-STAR SURGICAL LASER SYSTER2Cleared 510(K)
- K001746LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (FAMILY OF PRODUCTS)2Cleared 510(K)
- K001511O-LAS OPHTHALMIC PHOTODISRUPTOR2Cleared 510(K)
- K993328SURGILIGHT, INC EXCIMER LASER2Cleared 510(K)
- K001322PERFORMER 30 HPS2Cleared 510(K)
- K001031URANUS, COMFORTOUCH LASER SYSTEM2Cleared 510(K)
- K993154LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM2Cleared 510(K)
- K992757CYNOSURE APOGEE-TKS DERMATOLOGICAL LASER2Cleared 510(K)
- K000990OPUS 10 DENTAL DIODE LASER2Cleared 510(K)
- K000072DORNIER MEDILAS D SKINPULSE2Cleared 510(K)
- K994116LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM)2Cleared 510(K)
- K994260CANDELA GENTLELASE GL DERMATOLOGICAL LASER2Cleared 510(K)
- K001243DORNIER MEDILAS H2Cleared 510(K)
- K994225PALOMAR SLP 20002Cleared 510(K)
- K000693UMECO OPTIMA MULTILINE LASER SYSTEM2Cleared 510(K)
- K000503MEDART 520 COOLING SYSTEM2Cleared 510(K)
- K993815UNI-LASER 4302Cleared 510(K)
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