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by
Innolitics
Anesthesiology
Review Panel
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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
K
22
0793
InnoVoyce Laser Fiber
2
Cleared 510(K)
K
22
0381
Diode Laser Therapy Systems
2
Cleared 510(K)
K
21
1534
RevoLix HTL
2
Cleared 510(K)
K
22
0467
The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories
2
Cleared 510(K)
K
22
0041
HandPICO
2
Cleared 510(K)
K
21
3594
ECHOLASER X4
2
Cleared 510(K)
K
22
0189
LISA Laser Surgical Fibers
2
Cleared 510(K)
K
21
3889
PicoStar
2
Cleared 510(K)
K
21
0183
Waterlase iPLus
2
Cleared 510(K)
K
21
3484
SmoothCool HR System
2
Cleared 510(K)
K
21
3350
mJOULE System and Accessories
2
Cleared 510(K)
K
21
0634
MCL 31 Dermablate System
2
Cleared 510(K)
K
22
0103
LED Therapy Device (Planar LED/Planar LED mini)
2
Cleared 510(K)
K
21
3557
Finexel
2
Cleared 510(K)
K
21
1681
EON
2
Cleared 510(K)
K
21
3461
AviClear Laser System
2
Cleared 510(K)
K
22
0426
Fiber Dust PRO
2
Cleared 510(K)
K
21
1722
Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares
2
Cleared 510(K)
K
22
0020
Cryo 7
2
Cleared 510(K)
K
21
3569
HOLLYWOOD SPECTRA Laser System
2
Cleared 510(K)
K
21
3554
Sentient Manufacturing Laser Fiber
2
Cleared 510(K)
K
21
1228
Rosso
2
Cleared 510(K)
K
21
2611
CO2 Laser Equipment
2
Cleared 510(K)
K
20
3395
Platform treatment system
2
Cleared 510(K)
K
21
2478
Dermatological diode laser system
2
Cleared 510(K)
K
21
2127
Picocaremajesty
2
Cleared 510(K)
K
21
3225
Diode Laser System GP900A8, Diode Laser System GP900Q8
2
Cleared 510(K)
K
21
2492
Frax 1940 for Nordlys and Frax Pro
2
Cleared 510(K)
K
20
2848
S2 Pigment Removal System
2
Cleared 510(K)
K
21
0847
UltraClear Fractional Laser System
2
Cleared 510(K)
K
21
2573
PicoLO Premium
2
Cleared 510(K)
K
20
2175
OxyLight 2.0
2
Cleared 510(K)
K
20
2288
Finebeam
2
Cleared 510(K)
K
21
2607
Darwin
2
Cleared 510(K)
K
21
2978
Diode laser therapy system
2
Cleared 510(K)
K
21
1517
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)
K
21
2502
Resonic Rapid Acoustic Pulse Device
2
Cleared 510(K)
K
21
1977
Medical Diode Laser Systems
2
Cleared 510(K)
K
20
2998
Vydence Zye and Vydence One
2
Cleared 510(K)
K
21
2793
Laser Treatment System, Model: Hera, Armo
2
Cleared 510(K)
K
21
1735
CO2 Laser Machine, Model: BW-203B
2
Cleared 510(K)
K
21
2270
DEKA LipoAI
2
Cleared 510(K)
K
21
2703
AcuPulse CO2 Laser System, Delivery Devices and Accessories
2
Cleared 510(K)
K
20
1773
PICOHI
2
Cleared 510(K)
K
21
2082
Picore
2
Cleared 510(K)
K
20
3799
ProFlex CO2 Laser Fiber
2
Cleared 510(K)
K
21
1637
AROMA GRAND
2
Cleared 510(K)
K
21
0951
Leonardo Mini Blue
2
Cleared 510(K)
K
21
1362
SCAR 3
2
Cleared 510(K)
K
21
1761
UltraLase Flexible CO2 Laser Waveguide
2
Cleared 510(K)
K
21
1335
Diode Laser Machine, Model Number: BM-100
2
Cleared 510(K)
K
20
3728
Darwin
2
Cleared 510(K)
K
21
1821
DEKA Motus AZ
2
Cleared 510(K)
K
20
3441
The Alma Hybrid Laser System
2
Cleared 510(K)
K
20
2991
Fotona XPulse Pro Laser Platform
2
Cleared 510(K)
K
20
2828
Surgical Green Laser System
2
Cleared 510(K)
K
21
1401
SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
2
Cleared 510(K)
K
21
0535
UltraLight LED System
2
Cleared 510(K)
K
21
0168
Diode Laser Therapy Systems
2
Cleared 510(K)
K
21
0925
Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber
2
Cleared 510(K)
K
21
0964
Resonic Rapid Acoustic Pulse Device
2
Cleared 510(K)
K
21
0663
Dermatological Diode Laser Systems
2
Cleared 510(K)
K
20
2258
ERISE Laser handpiece
2
Cleared 510(K)
K
20
2257
Dermatological Diode Laser Systems
2
Cleared 510(K)
K
20
2043
Secret Duo
2
Cleared 510(K)
K
20
3491
PicoLO Nd: YAG Picosecond Laser System
2
Cleared 510(K)
K
20
1171
LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable
2
Cleared 510(K)
K
21
0226
PicoSure Workstation
2
Cleared 510(K)
K
20
3788
DermaV Laser System
2
Cleared 510(K)
K
20
1466
Tranberg CLS Laser Applicator
2
Cleared 510(K)
K
20
2985
LightWalker Laser System Family
2
Cleared 510(K)
K
21
0142
Fiber Dust
2
Cleared 510(K)
K
20
3054
FlexSys
2
Cleared 510(K)
K
21
0033
Laser Treatment System, Model: NYX and Grace
2
Cleared 510(K)
K
20
2702
FLARE Single-Use Surgical Laser Fiber
2
Cleared 510(K)
K
20
3804
Global Med Systems Milesman Compact Laser
2
Cleared 510(K)
K
20
1801
Rapid Acoustic Pulse Device
2
Cleared 510(K)
K
19
3266
MIIN
2
Cleared 510(K)
K
20
3241
OmniGuide BeamPath OTO-U Fiber
2
Cleared 510(K)
K
20
3544
UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories
2
Cleared 510(K)
K
20
1594
Primelase Excellence
2
Cleared 510(K)
K
20
2601
Single-use Sterile medical laser fiber
2
Cleared 510(K)
K
20
1687
Avenda Health Treatment System
2
Cleared 510(K)
K
20
2250
Dermatological Carbon Dioxide Laser Systems
2
Cleared 510(K)
K
20
2980
Laser Therapy Device
2
Cleared 510(K)
K
20
2172
StarWalker
2
Cleared 510(K)
K
20
0693
K2 MOBILE
2
Cleared 510(K)
K
20
2503
Chrome
2
Cleared 510(K)
K
20
2758
Nd: YAG Laser Therapy Systems HM-YL900
2
Cleared 510(K)
K
20
2428
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
2
Cleared 510(K)
K
20
2041
Opera Evo
2
Cleared 510(K)
K
20
1056
NeuroBlate System
2
Cleared 510(K)
K
20
1406
Picowon
2
Cleared 510(K)
K
20
1663
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
2
Cleared 510(K)
K
20
1109
CO2 Laser Therapy System
2
Cleared 510(K)
K
20
1455
Litho 150, Cyber Ho 150
2
Cleared 510(K)
K
20
0736
Stardust Med
2
Cleared 510(K)
K
19
3477
Nd: YAG Laser Therapy Systems
2
Cleared 510(K)
K
20
0786
Venus Epileve
2
Cleared 510(K)
K
20
0042
CO2 Laser System
2
Cleared 510(K)
K
20
0104
Oxylight
2
Cleared 510(K)
K
20
0116
PicoSecond Nd: YAG Laser System
2
Cleared 510(K)
K
20
0525
Medical Diode Laser Hair Removal System
2
Cleared 510(K)
K
20
1111
GentleMax Pro Plus
2
Cleared 510(K)
K
20
0751
Photodynamic Therapy (PDT) Equipment
2
Cleared 510(K)
K
20
0659
Dermalux Tri-Wave MD
2
Cleared 510(K)
K
19
2856
MT One
2
Cleared 510(K)
K
20
0118
Diode Laser Therapy Device
2
Cleared 510(K)
K
19
3464
ND:YAG Laser
2
Cleared 510(K)
K
19
1970
Diode Laser Hair Removal System
2
Cleared 510(K)
K
19
2735
Diode Laser Hair Removal Machine
2
Cleared 510(K)
K
19
3656
SkyPulse
2
Cleared 510(K)
K
19
2951
Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun
2
Cleared 510(K)
K
19
3661
LightWalker Laser System Family
2
Cleared 510(K)
K
19
3609
Q Switched Nd: YAG Laser machine
2
Cleared 510(K)
K
19
2272
Wolf445nm
2
Cleared 510(K)
K
20
0110
SANDRO Dual
2
Cleared 510(K)
K
19
3486
Epic 980
2
Cleared 510(K)
K
19
2483
MeDioStar
2
Cleared 510(K)
K
19
3367
elysion-pro
2
Cleared 510(K)
K
20
0331
Rapid Acoustic Pulse Device
2
Cleared 510(K)
K
19
3446
Bare: 808
2
Cleared 510(K)
K
19
3426
Elite iQ
2
Cleared 510(K)
K
20
0234
Surgical laser fibers
2
Cleared 510(K)
K
19
2600
Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60
2
Cleared 510(K)
K
19
2617
Gemini 810+980 Soft Tissue Laser
2
Cleared 510(K)
K
19
2583
PicoLazer Laser System
2
Cleared 510(K)
K
19
3500
Stellar M22 for Intense Pulsed Light (IPL) and Laser System
2
Cleared 510(K)
K
19
3478
XTRAC Momentum Excimer Laser System
2
Cleared 510(K)
K
19
3375
NeuroBlate System
2
Cleared 510(K)
K
19
1501
PALLAS 308/311 Solid-State UV Laser System
2
Cleared 510(K)
K
19
2990
Litho Evo
2
Cleared 510(K)
K
19
2755
Soli-Lite LG4 Galileo
2
Cleared 510(K)
K
19
2539
Deka Luxea
2
Cleared 510(K)
K
19
2569
Diode Laser Therapy System
2
Cleared 510(K)
K
19
2516
Diode Laser 808nm
2
Cleared 510(K)
K
19
1962
Vitra 2
2
Cleared 510(K)
K
19
2430
Epic 980
2
Cleared 510(K)
K
19
2528
CO2 Laser Therapy System
2
Cleared 510(K)
K
19
2269
TwinScan 808/755 Laser System
2
Cleared 510(K)
K
19
2331
LaseMD LEO Laser System
2
Cleared 510(K)
K
19
1693
BC-5
2
Cleared 510(K)
K
19
1942
MT One Diamond
2
Cleared 510(K)
K
19
0319
Waterlase Laser System Family
2
Cleared 510(K)
K
19
1842
Discovery Pico, Discovery Pico Plus, Discovery Pico Derm
2
Cleared 510(K)
K
19
1685
PicoWay Laser System
2
Cleared 510(K)
K
19
1518
CO2 Laser System
2
Cleared 510(K)
K
18
1602
Pioneer Elite Diode Laser
2
Cleared 510(K)
K
18
1614
Sterling Supreme Diode Laser
2
Cleared 510(K)
K
18
1601
Precise SHP Diode Laser
2
Cleared 510(K)
K
19
2160
EVO Platform
2
Cleared 510(K)
K
18
3563
Holinwon 30
2
Cleared 510(K)
K
19
1554
LightWalker Laser System Family
2
Cleared 510(K)
K
18
3122
810nm Diode Laser System
2
Cleared 510(K)
K
19
1349
980nm Diode Laser Therapy Device
2
Cleared 510(K)
K
18
3647
SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)
2
Cleared 510(K)
K
19
1321
Primelase Excellence
2
Cleared 510(K)
K
19
1611
Diode Laser Therapy Systems
2
Cleared 510(K)
K
18
2930
PerioLase Nd:YAG Pulsed Dental Laser System
2
Cleared 510(K)
K
19
1162
EpiLaze Multi-wavelength Laser
2
Cleared 510(K)
K
19
0938
Photodynamic Therapy System
2
Cleared 510(K)
K
19
0936
Q-Switched Nd: YAG Laser System
2
Cleared 510(K)
K
18
3566
CLARITY II Laser System
2
Cleared 510(K)
K
18
0511
eon
2
Cleared 510(K)
K
19
0542
Soliton Acoustic Wave Device
2
Cleared 510(K)
K
18
3199
TRIO Handpiece
2
Cleared 510(K)
K
18
3156
V-Laser
2
Cleared 510(K)
K
18
2924
Diode Laser Treatment System
2
Cleared 510(K)
K
19
0392
WaveLight FS200 Patient Interface
2
Cleared 510(K)
K
18
2173
Joule System
2
Cleared 510(K)
K
19
0007
Vydence Laser Family
2
Cleared 510(K)
K
18
3452
Vbeam Prima Laser System
2
Cleared 510(K)
K
18
3392
PicoLO Nd:YAG Picosecond Laser System
2
Cleared 510(K)
K
18
2045
Lotus III Multi-Pulsed Er: Yag Laser System
2
Cleared 510(K)
K
18
2997
enlighten III Laser System
2
Cleared 510(K)
K
18
3307
Magma Spark Pro (Magma Spark Plus, Alpha)
2
Cleared 510(K)
K
18
2831
SabreLine and SabreGuard Laser Fibers
2
Cleared 510(K)
K
18
2663
Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System
2
Cleared 510(K)
K
18
2604
New Era
2
Cleared 510(K)
K
18
2270
Cellene CO2 Laser System
2
Cleared 510(K)
K
18
2088
XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro
2
Cleared 510(K)
K
18
2669
Youlaser CO2
2
Cleared 510(K)
K
18
2036
NeuroBlate System
2
Cleared 510(K)
K
18
1867
Deka Smartxide2 Trio
2
Cleared 510(K)
K
18
1632
Venacure 1470 Pro
2
Cleared 510(K)
K
17
3827
LightScalpel
2
Cleared 510(K)
K
17
3676
A-FIT
2
Cleared 510(K)
K
18
1662
Iridex TruFocus LIO Premiere
2
Cleared 510(K)
K
18
1510
ECHOLASER X4
2
Cleared 510(K)
K
18
1486
DEKA Motus AY
2
Cleared 510(K)
K
18
1480
MMD Tip
2
Cleared 510(K)
K
18
1272
Picocare Family
2
Cleared 510(K)
K
18
1431
Laser Ureteral Catheter
2
Cleared 510(K)
K
18
0518
GME LinScan Lite 808 Laser System
2
Cleared 510(K)
K
18
1019
Diode Laser System
2
Cleared 510(K)
K
18
1523
Syneron CO2RE System
2
Cleared 510(K)
K
18
0967
Dental Diode Laser System
2
Cleared 510(K)
K
18
1044
400um Perforator and Accessory Vein Ablation Kit
2
Cleared 510(K)
K
17
3359
Fractional CO2 Surgical Laser System
2
Cleared 510(K)
K
18
0993
Beacon Advanced CO2 Laser System
2
Cleared 510(K)
K
17
3700
PICOPLUS Laser System
2
Cleared 510(K)
K
18
0719
InMode Diolaze System
2
Cleared 510(K)
K
18
0593
Vbeam Prima Laser System
2
Cleared 510(K)
K
18
0508
JOULE SYSTEM
2
Cleared 510(K)
K
18
0922
Empower H100, Cyber Ho 100, Litho 100
2
Cleared 510(K)
K
18
0140
ProFlex Laser Fibers
2
Cleared 510(K)
K
17
1443
Etherea MX
2
Cleared 510(K)
K
18
0353
Diode laser hair removal device
2
Cleared 510(K)
K
18
0597
AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO
2
Cleared 510(K)
K
18
0426
Empower H35
2
Cleared 510(K)
K
18
0423
Empower H65
2
Cleared 510(K)
K
18
0406
Ellipse Ydun
2
Cleared 510(K)
K
18
0224
ELEMENT-TL
2
Cleared 510(K)
K
18
0044
SIROLaser Blue
2
Cleared 510(K)
K
18
0350
Dornier Medilas H Solvo 35 Laser
2
Cleared 510(K)
K
17
2818
LMT-3000
2
Cleared 510(K)
K
17
3677
InMode VLaze
2
Cleared 510(K)
K
17
3067
LightForce LTS Model 1000, 1500, 2500, and 4000
2
Cleared 510(K)
K
18
0193
DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)
2
Cleared 510(K)
K
18
0158
Surgical Laser fibers
2
Cleared 510(K)
K
17
2439
Siberian Fit
2
Cleared 510(K)
K
17
3199
PicoSure Workstation
2
Cleared 510(K)
K
17
3285
JOULE SYSTEM
2
Cleared 510(K)
K
17
2193
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)
K
17
3002
2940 nm Er:Yag Laser Handpiece
2
Cleared 510(K)
K
17
2908
Q-Switched Nd:YAG Laser System
2
Cleared 510(K)
K
17
3038
CuRAS Nd:YAG Laser
2
Cleared 510(K)
K
17
2819
LightWalker Laser System Family
2
Cleared 510(K)
K
17
2771
Epic Pro 940
2
Cleared 510(K)
K
17
3169
Rapid Family
2
Cleared 510(K)
K
17
3305
NeuroBlate System
2
Cleared 510(K)
K
17
2362
DEKA SMARTXIDE TOUCH
2
Cleared 510(K)
K
17
2363
DEKA SMARTXIDE ULTRASPEED
2
Cleared 510(K)
K
17
2639
PALLAS 308/311 Solid-State UV Laser System
2
Cleared 510(K)
K
17
2077
Cutera enlighten III Laser System
2
Cleared 510(K)
K
17
2325
Rhapsody H-30 Holmium Laser System
2
Cleared 510(K)
K
17
2881
NeuroBlate System
2
Cleared 510(K)
K
17
2376
Discovery Pico, Discovery Pico Plus
2
Cleared 510(K)
K
17
2198
585
2
Cleared 510(K)
K
17
2413
MT ONE
2
Cleared 510(K)
K
17
1986
Sterling Supreme Diode Laser
2
Cleared 510(K)
K
17
0179
LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity
2
Cleared 510(K)
K
17
0409
PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System
2
Cleared 510(K)
K
17
1648
BM.IRIS
2
Cleared 510(K)
K
17
0970
Epilaser
2
Cleared 510(K)
K
17
1921
VenaCure EVLT NeverTouch Procedure Kit
2
Cleared 510(K)
K
17
1227
StarWalker
2
Cleared 510(K)
K
17
2096
Fraxis
2
Cleared 510(K)
K
17
0060
M22 and ResurFx Systems
2
Cleared 510(K)
K
17
0738
InMode Diolaze XL
2
Cleared 510(K)
K
17
1079
Q-Switched Nd:YAG Laser System
2
Cleared 510(K)
K
17
2025
Litho 60
2
Cleared 510(K)
K
17
1945
Discovery Pico, Discovery Pico Plus
2
Cleared 510(K)
K
17
0187
Photodynamic Therapy Device
2
Cleared 510(K)
K
17
1255
Monteris Medical NeuroBlate System
2
Cleared 510(K)
K
17
0073
LightMed Dental Laser System
2
Cleared 510(K)
K
17
1711
Thunder, Thunder VT, Thunder HR
2
Cleared 510(K)
K
17
1009
LASEMD Laser System
2
Cleared 510(K)
K
16
3449
HyPHo Laser System
2
Cleared 510(K)
K
16
2886
DEKA MOTUS AX
2
Cleared 510(K)
K
16
2659
Diode Laser Hair Removal System
2
Cleared 510(K)
K
17
0850
Alma Q
2
Cleared 510(K)
K
16
2755
Picocare
2
Cleared 510(K)
K
17
0366
Laser Peripherals, LLC Family of Bare Laser Fibers
2
Cleared 510(K)
K
17
0626
Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece
2
Cleared 510(K)
K
17
0597
PicoWay Laser System
2
Cleared 510(K)
K
16
3197
Cook Holmium Laser Fiber
2
Cleared 510(K)
K
16
3196
ACTION II Laser System
2
Cleared 510(K)
K
17
0121
Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories
2
Cleared 510(K)
K
16
0677
MICRORUPTOR 6
2
Cleared 510(K)
K
17
0500
SIROLaser Advance+
2
Cleared 510(K)
K
16
3638
Dental 5 Multi Diode laser
2
Cleared 510(K)
K
17
0734
Venus Silk.expert
2
Cleared 510(K)
K
17
0718
Iridex TruFocus LIO Premiere
2
Cleared 510(K)
K
16
2334
U.S. Laser Worx Patriot 1 family of lasers
2
Cleared 510(K)
K
17
0936
Cutera enlighten III Laser System
2
Cleared 510(K)
K
17
0215
LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock
2
Cleared 510(K)
K
17
0724
NeuroBlate System
2
Cleared 510(K)
K
16
0549
MEDICAL DIODE LASER SYSTEMS
2
Cleared 510(K)
K
16
1257
MultiPulse HoPLUS
2
Cleared 510(K)
K
16
2556
LIGHTFUSION LED SYSTEM
2
Cleared 510(K)
K
16
3103
Tranberg CLS Diffusor Laser Fiber
2
Cleared 510(K)
K
16
3655
Sparkling
2
Cleared 510(K)
K
17
0331
Cyber Ho
2
Cleared 510(K)
K
16
2837
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)
K
16
1926
ND YAG Q-switch Laser Therapy Machine
2
Cleared 510(K)
K
16
3123
Q-Switched Nd:YAG Laser Therapy Systems
2
Cleared 510(K)
K
16
2454
PicoWay Laser System
2
Cleared 510(K)
K
16
2851
eLyx-PRO
2
Cleared 510(K)
K
16
3128
Epic Pro
2
Cleared 510(K)
K
16
2765
Venus Velocity Diode Laser System
2
Cleared 510(K)
K
16
2114
Photon, Photon Plus
2
Cleared 510(K)
K
16
1632
FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)
2
Cleared 510(K)
K
16
3222
Discovery Pico Family
2
Cleared 510(K)
K
16
3009
Litho
2
Cleared 510(K)
K
16
2191
NAVILAS Laser System
2
Cleared 510(K)
K
16
2363
V30 system, V-Form Handpiece BC Medium applicator
2
Cleared 510(K)
K
16
2914
VenaCure EVLT NeverTouch Procedure Kit
2
Cleared 510(K)
K
16
1692
Diode Laser Therapy Machine
2
Cleared 510(K)
K
16
2781
Magma Spark
2
Cleared 510(K)
K
16
1670
Lucid Q-PTP / HWA 55
2
Cleared 510(K)
K
16
0488
Cutera enlighten III Laser System
2
Cleared 510(K)
K
16
0312
FRAXIS DUO
2
Cleared 510(K)
K
16
2169
EdgeOne CO2 Laser
2
Cleared 510(K)
K
16
2762
NeuroBlate System
2
Cleared 510(K)
K
16
1981
Olive Plus
2
Cleared 510(K)
K
16
1925
CO2 Laser Therapy Machine
2
Cleared 510(K)
K
16
2416
IRIDEX Cyclo G6 Laser System, G-Probe Illuminate
2
Cleared 510(K)
K
16
1185
LUCERNA Dental Laser
2
Cleared 510(K)
K
16
0413
Sterling 5W Diode Laser
2
Cleared 510(K)
K
16
1162
Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
2
Cleared 510(K)
K
16
1356
Matrix LS-40 CO2 Laser System
2
Cleared 510(K)
K
16
1503
ORION
2
Cleared 510(K)
K
16
1403
A.R.C. Laser Surgical Fibers and Probes
2
Cleared 510(K)
K
16
1771
Medilas H Laser Fibers
2
Cleared 510(K)
K
16
1669
Waterlase Express
2
Cleared 510(K)
K
15
3124
DuraLazeTM HoLEP Laser Fiber
2
Cleared 510(K)
K
16
0607
PicoWay Laser System
2
Cleared 510(K)
K
15
2737
Lite Touch
2
Cleared 510(K)
K
15
2667
ATOVEN-Reusable Laser Fiber
2
Cleared 510(K)
K
16
0012
O-pel Laser and families of probe delivery devices
2
Cleared 510(K)
K
15
2856
Helios III
2
Cleared 510(K)
K
16
0480
PicoSure Workstation
2
Cleared 510(K)
K
16
0952
Alma Diode Tabletop Laser
2
Cleared 510(K)
K
16
0227
ACCENTO / HWA Dual/Single laser
2
Cleared 510(K)
K
15
1855
SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber
2
Cleared 510(K)
K
15
3229
Superbium
2
Cleared 510(K)
K
15
3566
Magma System
2
Cleared 510(K)
K
16
0368
EVO platform
2
Cleared 510(K)
K
15
3564
PURE CRYOGEN
2
Cleared 510(K)
K
16
0513
Quanta System Surgical Laser fibers
2
Cleared 510(K)
K
15
1763
PerioLase Nd:YAG Pulsed Dental Laser System
2
Cleared 510(K)
K
15
3671
Family of CoolGlide Aesthetic Lasers
2
Cleared 510(K)
K
15
3527
PicoWay Laser System
2
Cleared 510(K)
K
16
0392
Novilase Laser Therapy System, Model LTS-2
2
Cleared 510(K)
K
15
2736
SKIN CARE
2
Cleared 510(K)
K
15
2611
V20 system
2
Cleared 510(K)
K
15
3718
Spirit Hair Removal laser Family
2
Cleared 510(K)
K
15
1569
Tranberg CLS Laser Fiber
2
Cleared 510(K)
K
15
2898
DIODE LASER THERAPY SYSTEMS
2
Cleared 510(K)
K
15
2529
NaturaLase CO2 Laser System
2
Cleared 510(K)
K
14
3713
Lustre PRO Light System
2
Cleared 510(K)
K
15
1890
Medical Diode Laser Systems
2
Cleared 510(K)
K
15
0997
RUBY STAR
2
Cleared 510(K)
K
15
0664
NeoLas
2
Cleared 510(K)
K
15
2714
Quanta Forte
2
Cleared 510(K)
K
15
2636
Laser Dock
2
Cleared 510(K)
K
15
2153
MicroSpot Handpiece
2
Cleared 510(K)
K
15
2722
neoV980 & neoV1470 Diode Lasers
2
Cleared 510(K)
K
15
2012
EVO platform
2
Cleared 510(K)
K
15
2417
Adler MicroMed Laser Surgery Fibers
2
Cleared 510(K)
K
15
2939
Picasso Plus, Picasso Lite Plus
2
Cleared 510(K)
K
15
1109
Lumenis Smart532 Laser System
2
Cleared 510(K)
K
15
1629
Guardian 1000
2
Cleared 510(K)
K
15
2591
Medilas H RFID Laser Fibers
2
Cleared 510(K)
K
15
1306
Solea
2
Cleared 510(K)
K
15
2032
ELUMI 810 + 980 Soft Tissue Laser
2
Cleared 510(K)
K
15
1655
CO2RE System
2
Cleared 510(K)
K
15
2220
MH01
2
Cleared 510(K)
K
15
1473
NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module
2
Cleared 510(K)
K
15
1947
LightSheer Desire Light Laser System
2
Cleared 510(K)
K
15
1232
VIKINI Diode Laser System
2
Cleared 510(K)
K
15
0587
Cortex Laser System
2
Cleared 510(K)
K
15
0907
Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra
2
Cleared 510(K)
K
15
1331
The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch
2
Cleared 510(K)
K
15
0140
MCL 31 Dermablate
2
Cleared 510(K)
K
14
0386
LUMINA 24
2
Cleared 510(K)
K
14
3666
Noblex Long Pulse Alexandrite Laser
2
Cleared 510(K)
K
14
2216
Tranberg CLS Thermal Therapy System
2
Cleared 510(K)
K
14
2186
DIODE LASER HAIR REMOVAL SYSTEM
2
Cleared 510(K)
K
15
0326
PicoWay Laser System
2
Cleared 510(K)
K
15
0516
DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS
2
Cleared 510(K)
K
14
3723
SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro
2
Cleared 510(K)
K
15
0027
CYMA
2
Cleared 510(K)
K
13
3788
COOK HOLMIUM LASER FIBER
2
Cleared 510(K)
K
14
3519
The MeDioStar NeXT Family
2
Cleared 510(K)
K
14
1975
WATERLASE IPLUS S
2
Cleared 510(K)
K
15
0336
Photonica Professional
2
Cleared 510(K)
K
14
3105
Picosure Workstation
2
Cleared 510(K)
K
14
3457
NeuroBlate System
2
Cleared 510(K)
K
14
2924
Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family
2
Cleared 510(K)
K
14
1986
ELUX 810 LASER
2
Cleared 510(K)
K
13
3891
MULTIPULSE TM+1470
2
Cleared 510(K)
K
14
1511
SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS
2
Cleared 510(K)
K
14
2860
Lumenis M22 System
2
Cleared 510(K)
K
14
2952
InMode Diolaze Device
2
Cleared 510(K)
K
14
1852
IFS ADVANCED FEMTOSECOND LASER SYSTEM
2
Cleared 510(K)
K
14
3154
IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID)
2
Cleared 510(K)
K
14
1851
NAVILAS LASER SYSTEM
2
Cleared 510(K)
K
14
2638
ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273)
2
Cleared 510(K)
K
14
2093
V20 SYSTEM
2
Cleared 510(K)
K
14
0732
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
2
Cleared 510(K)
K
14
1555
ADVANTAGE
2
Cleared 510(K)
K
14
0727
CUTERA PICOSECOND LASER SYSTEM
2
Cleared 510(K)
K
14
2286
NS3000 Holmium Laser System
2
Cleared 510(K)
K
14
2372
Pico Way Laser System
2
Cleared 510(K)
K
14
1908
DUAL SWITCH
2
Cleared 510(K)
K
14
1658
LIGHT SCALPEL
2
Cleared 510(K)
K
14
0470
OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER
2
Cleared 510(K)
K
13
1987
MULTIPULSE HOPLUS
2
Cleared 510(K)
K
14
2614
AngioDynamics VenaCure EVLT Tre’ Sheath and VenaCure EVLT NeverTouch Procedure Kits
2
Cleared 510(K)
K
14
0120
EPIC 10
2
Cleared 510(K)
K
14
0249
LONG PULSE ND: YAG LASER SYSTEM
2
Cleared 510(K)
K
14
1973
DIODE LASER HAIR REMOVAL SYSTEM
2
Cleared 510(K)
K
14
0378
FLEXGUIDE ULTRA BEAMPATH ROBOTIC FIBER CONDUIT
2
Cleared 510(K)
K
14
2376
Palomar Icon Aesthetic System
2
Cleared 510(K)
K
14
0837
LUCID LY
2
Cleared 510(K)
K
14
0719
PICOSURE WORKSTATION
2
Cleared 510(K)
K
14
2226
Pilot Ultra Diode Laser
2
Cleared 510(K)
K
14
2223
Pilot Pro Diode Laser
2
Cleared 510(K)
K
14
2225
Pilot Elite Diode Laser
2
Cleared 510(K)
K
14
1425
ELITE + LASER SYSTEM
2
Cleared 510(K)
K
13
3895
DEKA SMARTXIDE LASER SYSTEM
2
Cleared 510(K)
K
14
0964
CALCULASE II
2
Cleared 510(K)
K
14
0009
SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM
2
Cleared 510(K)
K
14
0458
DIOTECH LASER FIBER
2
Cleared 510(K)
K
14
0366
ENDLESSFIBER REUSABLE SURGICAL LASER FIBER
2
Cleared 510(K)
K
14
1983
NEUROBLATE SYSTEM
2
Cleared 510(K)
K
13
3945
CUTERA PICOSECOND LASER SYSTEM
2
Cleared 510(K)
K
14
1101
LITHO
2
Cleared 510(K)
K
14
1403
LITHO DK30
2
Cleared 510(K)
K
14
1838
SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL)
2
Cleared 510(K)
K
13
3364
PICOSURE WORKSTATION
2
Cleared 510(K)
K
14
0005
ALMA DIODE TABLETOP LASER
2
Cleared 510(K)
K
13
1757
TATTOOSTAR EFFECT COMBO
2
Cleared 510(K)
K
14
1063
LINSCAN 808, LINSCAN 980
2
Cleared 510(K)
K
13
2806
FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE
2
Cleared 510(K)
K
14
0679
SUREFLEX LITHOTRIPSY LASER FIBERS
2
Cleared 510(K)
K
13
3297
QUADROSTARPROGREEN, QUADROSTARPROYELLOW
2
Cleared 510(K)
K
13
3774
ATOVEN
2
Cleared 510(K)
K
14
0122
CANDELA GENTLEMAX FAMILY OF LASER SYSTEM
2
Cleared 510(K)
K
13
1838
DIODE LASER FOR HIAR REMOVAL
2
Cleared 510(K)
K
13
3915
GALAXY CO2 LASER SYSTEM
2
Cleared 510(K)
K
13
3006
NEOV DIODE LASER FAMILY
2
Cleared 510(K)
K
13
2976
ADVATX
2
Cleared 510(K)
K
14
0503
FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER
2
Cleared 510(K)
K
13
3837
VIORA V-TOTAL
2
Cleared 510(K)
K
13
2607
NS 2500 HOLMIUM LASER SYSTEM
2
Cleared 510(K)
K
13
3319
ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060
2
Cleared 510(K)
K
13
2975
SPHINX JR
2
Cleared 510(K)
K
14
0388
LUMENIS PULSE 120H
2
Cleared 510(K)
K
12
2358
NOVEON
2
Cleared 510(K)
K
13
3254
REVLITE Q-SWITCHED ND:YAG LASER SYSTEM
2
Cleared 510(K)
K
13
3158
ND: YAG LASER SYSTEM
2
Cleared 510(K)
K
13
2989
SPEED 808 DIODE LASER SYSTEM
2
Cleared 510(K)
K
13
2286
HYPERION LONG PULSED ND: YAG LASER
2
Cleared 510(K)
K
13
1837
CO2 FRACTIONAL LASER
2
Cleared 510(K)
K
13
1857
Q-SWITCHED ND:YAG LASER
2
Cleared 510(K)
K
13
0681
ENDOVASCULAR LASER VENOUS SYSTEM KIT WITH 2 RING RADIAL EMITTING FIBER
2
Cleared 510(K)
K
13
2661
LIGHTSCALPEL
2
Cleared 510(K)
K
13
3283
CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS
2
Cleared 510(K)
K
13
3561
VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH
2
Cleared 510(K)
K
13
2185
FAMILY OF COOLGLIDE AESTHETIC LASERS
2
Cleared 510(K)
K
13
1095
DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS
2
Cleared 510(K)
K
13
1142
GENESIS LED WANDS
2
Cleared 510(K)
K
13
0199
CLARITY LPC LASER SYSTEM
2
Cleared 510(K)
K
13
1839
DC 7
2
Cleared 510(K)
K
13
1894
NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT
2
Cleared 510(K)
K
13
1473
(QUANTA SYSTEM) SURGICAL LASER FIBERS
2
Cleared 510(K)
K
13
1059
PIONEER ELITE DIODE LASER
2
Cleared 510(K)
K
12
3443
PRECISE SHP DIODE LASER
2
Cleared 510(K)
K
13
1955
NEUROBLATE(TM) SYSTEM
2
Cleared 510(K)
K
13
1805
INPULSE LASER
2
Cleared 510(K)
K
13
0420
SOLEA
2
Cleared 510(K)
K
13
1278
MONTERIS MEDICAL NEUROBLATE SYSTEM
2
Cleared 510(K)
K
13
1081
CYBER TM FAMILY
2
Cleared 510(K)
K
13
0256
MDK MULTI-APPLICATIONS PLATFORM
2
Cleared 510(K)
K
12
4030
COOK HOLMIUM LASER FIBER
2
Cleared 510(K)
K
12
2567
JOULE 810/940/980 MULTI-PLATFORM SYSTEM
2
Cleared 510(K)
K
13
0193
FRAXEL DUAL 1550/1927 LASER SYSTEM
2
Cleared 510(K)
K
12
2020
PHOTON PHOTON PLUS
2
Cleared 510(K)
K
13
0444
H-30 HOLMIUM LASER SYSTEM
2
Cleared 510(K)
K
12
2493
GENESISPLUS
2
Cleared 510(K)
K
13
0250
QYAG LASER SYSTEM
2
Cleared 510(K)
K
12
2368
WATERLASE IPLUS ALL TISSUE LASER
2
Cleared 510(K)
K
12
3483
DIODE LASER
2
Cleared 510(K)
K
12
3573
YOULASER CO2 LASER
2
Cleared 510(K)
K
13
0465
EPIC 10S
2
Cleared 510(K)
K
12
3777
MULTILASER SYSTEM
2
Cleared 510(K)
K
12
3293
PASTELLE Q-SWITCHED ND: YAG LASER
2
Cleared 510(K)
K
12
0561
NEUROBLATE SYSTEM
2
Cleared 510(K)
K
13
0671
VENACURE EVLT NEVERTOUCH PROCEDURE KIT
2
Cleared 510(K)
K
13
0164
FIBERLASE ENDURE CO2 FIBER
2
Cleared 510(K)
K
13
0413
PINPOINTE FOOTLASER
2
Cleared 510(K)
K
13
0344
DORNIER MEDILAS UROPULSE
2
Cleared 510(K)
K
12
3682
INMODE HAIR REMOVAL (HR) DEVICE
2
Cleared 510(K)
K
11
0941
REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200
2
Cleared 510(K)
K
12
3494
SOLEA
2
Cleared 510(K)
K
12
2159
DORNIER MEDILAS H30 SOLVO
2
Cleared 510(K)
K
12
1327
DIOLASE 10S
2
Cleared 510(K)
K
11
3504
DEKA SMARTXIDE AND DELIVERY ACCESSORIES
2
Cleared 510(K)
K
12
2251
VITRA MULTISPOT
2
Cleared 510(K)
K
12
4003
MED-FIBERS SURGICAL LASER FIBER, MED-FIBERS ENDO-ENT LASER PROBES, MED-FIBERS END- AND ASPIRATING LASER PROBES, MED-FIBE
2
Cleared 510(K)
K
12
1570
AURIGA QI
2
Cleared 510(K)
K
12
3004
MIRA LASERS
2
Cleared 510(K)
K
12
2922
E-BEAM ND: YAG LASER
2
Cleared 510(K)
K
12
3168
Q-PLUS T+ IPL LASER SYSTEM
2
Cleared 510(K)
K
12
3385
MEDILAS H LASER FIBERS
2
Cleared 510(K)
K
12
3257
EMVERA DIOLUX
2
Cleared 510(K)
K
11
3018
APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM
2
Cleared 510(K)
K
12
0932
OPELASER PRO II AND THE OPELASER LITE II
2
Cleared 510(K)
K
12
3031
BWF-5 MEDICAL LASER SERIES
2
Cleared 510(K)
K
12
3037
LIGHTSCALPEL
2
Cleared 510(K)
K
12
1475
TXCELL SCANNING LASER DELIVERY SYSTEM
2
Cleared 510(K)
K
12
1346
PICOSURE WORKSTATION
2
Cleared 510(K)
K
12
0460
SMARTLUX
2
Cleared 510(K)
K
12
1286
EPIC 10
2
Cleared 510(K)
K
12
1580
SURELASE CO2 LASER SYSTEM
2
Cleared 510(K)
K
12
0235
MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP
2
Cleared 510(K)
K
12
0737
TRIA LASER HAIR REMOVAL SYSTEM
2
Cleared 510(K)
K
11
3472
PRECISE SHP DIODE LASER
2
Cleared 510(K)
K
12
1938
MEDILAS H RFID LASER FIBER
2
Cleared 510(K)
K
12
0926
ENDOBEAM HOLMIUM LASER FIBERS
2
Cleared 510(K)
K
11
3489
ORION
2
Cleared 510(K)
K
12
0377
ADVERL EVO ER: YAG LASER FOR DENTISTRY MEY-1-A
2
Cleared 510(K)
K
12
1162
POLARIS Q-SWITCH RUBY SYSTEM
2
Cleared 510(K)
K
12
1471
LIGHTSCALPEL FAMILY OF HANDPIECE TIPS FOR CO2 SURGICAL LASERS
2
Cleared 510(K)
K
12
0810
FIBEROPTIC LASER DELIVERY SYSTEM
2
Cleared 510(K)
K
12
1031
WAVELIGHT FS200 PATIENT INTERFACE 1505
2
Cleared 510(K)
K
12
0870
GREENLIGHT MOXY FIBER OPTIC
2
Cleared 510(K)
K
12
0573
MEDART 620
2
Cleared 510(K)
K
11
3868
EPLUS SKIN TREATMENT SYSTEM
2
Cleared 510(K)
K
12
0622
PALOMAR VECTUS LASER
2
Cleared 510(K)
K
12
1127
SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS
2
Cleared 510(K)
K
11
2669
TATTOOSTAR EFFECT Y
2
Cleared 510(K)
K
12
0437
TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM
2
Cleared 510(K)
K
12
0231
EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL)
2
Cleared 510(K)
K
11
2141
SMARTEPIL,DEPILASE YAG LASE PLUS
2
Cleared 510(K)
K
11
2505
ETHEREA
2
Cleared 510(K)
K
11
3502
ADVANTAGE LASER SYSTEM
2
Cleared 510(K)
K
11
3115
EPICARE YAG
2
Cleared 510(K)
K
11
3688
MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM
2
Cleared 510(K)
K
11
3151
IFS LASER SYSTEM
2
Cleared 510(K)
K
11
3588
SPECTRA LASER SYSTEM
2
Cleared 510(K)
K
11
1689
STLASE
2
Cleared 510(K)
K
11
3390
LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500)
2
Cleared 510(K)
K
11
2600
ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT
2
Cleared 510(K)
K
11
3858
MEGABEAM ENDO-ENT PROBE
2
Cleared 510(K)
K
11
3709
MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE
2
Cleared 510(K)
K
11
3792
MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE
2
Cleared 510(K)
K
11
2013
EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER
2
Cleared 510(K)
K
11
3140
VARI-LASE WIREFIBER LASER FIBER
2
Cleared 510(K)
K
11
1303
DERMATOLOGICAL TREATMENT DEVICE FAMILY
2
Cleared 510(K)
K
11
2987
TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM
2
Cleared 510(K)
K
11
0364
DORNIER MEDILAS D LITEBEAM+ 1470
2
Cleared 510(K)
K
11
3212
DENTAL LASER THERAPY SYSTEM
2
Cleared 510(K)
K
11
2299
ENDOVASCULAR LASER VEIN SYSTEM KIT
2
Cleared 510(K)
K
11
2166
ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE
2
Cleared 510(K)
K
11
2715
CANDELA GENTLEMAX FAMILY OF LASERS
2
Cleared 510(K)
K
11
2442
RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
2
Cleared 510(K)
K
11
1475
AURIGA XL
2
Cleared 510(K)
K
11
2253
CERALAS 147NM DIODE LASER SYSTEM
2
Cleared 510(K)
K
10
2359
PICASSO/ PICASSO LITE/ PICASSO PERIO
2
Cleared 510(K)
K
11
1360
SHEAUMANN PL-980
2
Cleared 510(K)
K
11
2031
ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION
2
Cleared 510(K)
K
11
1359
SHEAUMANN PL-1064
2
Cleared 510(K)
K
11
2324
CERALAS 980NM DIODE LASER FAMILY
2
Cleared 510(K)
K
11
1592
YOULASER CO2 LASER SYSTEM
2
Cleared 510(K)
K
11
1213
VISION ONE LASER SYSTEM
2
Cleared 510(K)
K
11
1144
CANDELA GENTLELASE FAMILY OF LASERS
2
Cleared 510(K)
K
11
1851
MEDIOSTAR NEXT
2
Cleared 510(K)
K
11
0897
CORTEX CO2 / ER:YAG LASER SYSTEM
2
Cleared 510(K)
K
10
1306
SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A
2
Cleared 510(K)
K
11
0243
MEDART DIODE LASER SYSTEM & ACCESSORIES
2
Cleared 510(K)
K
11
0907
PALOMAR ICON (TM) AESTHETIC SYSTEM
2
Cleared 510(K)
K
10
2954
CUTERA QSWITCH LASER SYSTEM
2
Cleared 510(K)
K
11
0225
ANGIODYNAMICS, INC. VENACURE 1470 LASER
2
Cleared 510(K)
K
10
3455
SPECTRA LASER SYSTEM
2
Cleared 510(K)
K
11
0502
TRIPLEX ER. YAG / ND: YAG SYSTEM
2
Cleared 510(K)
K
11
0434
TRIXEL CO2 LASER
2
Cleared 510(K)
K
11
0304
APEX ER. YAG / IPL SYSTEM
2
Cleared 510(K)
K
10
3654
VELA XL
2
Cleared 510(K)
K
11
0685
FLEXIVA TRACTIP
2
Cleared 510(K)
K
11
0686
ACCUTRAC
2
Cleared 510(K)
K
10
1916
JOULE MULTI-PLATFORM SYSTEM
2
Cleared 510(K)
K
11
0080
RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
2
Cleared 510(K)
K
10
3753
SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER
2
Cleared 510(K)
K
11
0079
SPPHINE PLUS STM 3W DIODE LASER
2
Cleared 510(K)
K
10
3288
DEKA SYNCHRO FT
2
Cleared 510(K)
K
10
3539
QUANTA SYSTEM DUOLITE
2
Cleared 510(K)
K
10
3501
ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES
2
Cleared 510(K)
K
10
1904
SMARTXIDE 50 HS/MS
2
Cleared 510(K)
K
10
3667
SAPPHIRE ST PORTABLE DIODE LASER
2
Cleared 510(K)
K
10
2755
CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER
2
Cleared 510(K)
K
10
2796
ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT
2
Cleared 510(K)
K
10
2749
QUANTA CYBER TM 150W
2
Cleared 510(K)
K
10
2639
SL3
2
Cleared 510(K)
K
10
0199
ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND VENACUREEVLT PROCEDURE KIT
2
Cleared 510(K)
K
10
1817
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)
K
10
3118
REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR
2
Cleared 510(K)
K
10
2669
DIODE LASER THERAPY SYSTEM
2
Cleared 510(K)
K
10
1321
EMATRIX CO2
2
Cleared 510(K)
K
10
1712
ENDOVASCULAR LAER VEIN SYSTEM KIT
2
Cleared 510(K)
K
10
1006
WAVELIGHT FS200 LASER SYSTEM MODEL: FS200
2
Cleared 510(K)
K
09
3545
PINPOINTE FOOTLASER MODEL 6W, 30W, 100W
2
Cleared 510(K)
K
10
2716
MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS
2
Cleared 510(K)
K
10
2036
DOCTOR SURGERY DIODE LASERS FAMILY
2
Cleared 510(K)
K
10
1601
AFFIRM DO DIODE LASER
2
Cleared 510(K)
K
10
1573
ACCUSCULPT II LASER SYSTEM
2
Cleared 510(K)
K
09
2734
E-LIGHT LINE
2
Cleared 510(K)
K
10
1555
CO2 LASER SYSTEM
2
Cleared 510(K)
K
10
0726
CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM
2
Cleared 510(K)
K
10
1783
COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE
2
Cleared 510(K)
K
09
4049
STLASE DIODE LASER
2
Cleared 510(K)
K
10
1152
NATURALASE DIODE LASER FAMILY NATURALASE MODEL NL980, NATURALASE DIODE LASER FAMILY NATURALASE NL810
2
Cleared 510(K)
K
10
0143
PILOT DIODE LASER, MODEL 002-00139
2
Cleared 510(K)
K
10
0098
PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE
2
Cleared 510(K)
K
10
1658
WATERLASE MD TURBO PLUS MODEL 7200XXX
2
Cleared 510(K)
K
10
2050
Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6
2
Cleared 510(K)
K
10
0558
QUANTA DIODE LASER SYSTEM
2
Cleared 510(K)
K
10
0678
SUPRA SCAN DELIVERY SYSTEM
2
Cleared 510(K)
K
09
2860
LASEMAR 800, 1000, 1500
2
Cleared 510(K)
K
10
1415
THERACLEAR
2
Cleared 510(K)
K
10
0893
CHEVEUX DIODE LASER SYSTEM
2
Cleared 510(K)
K
10
0746
FIBER ONE
2
Cleared 510(K)
K
10
0194
OPTICAL INTEGRITY LASERGUARD FIBERS
2
Cleared 510(K)
K
09
3087
BWF-5 MEDICAL LASER SERIES
2
Cleared 510(K)
K
10
0415
ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM
2
Cleared 510(K)
K
10
0384
FIBERLASE C02 LASER WAVEGUIDE
2
Cleared 510(K)
K
10
0270
ARTISAN AESTHETIC SYSTEM
2
Cleared 510(K)
K
09
3048
D-STORM 810NM, D-STORM 980NM
2
Cleared 510(K)
K
10
0035
MODEL VISULAS 532S LASER WITH THE VITE OPTION
2
Cleared 510(K)
K
10
0474
QUICKLASEDUAL+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 MODEL: 3W,5W,3W,5W
2
Cleared 510(K)
K
09
3852
EZLASE 3 LASER SYSTEM
2
Cleared 510(K)
K
10
0228
VERSAPULSE MODEL P20 LASER SYSTEM
2
Cleared 510(K)
K
09
3793
LS-40 CO2 LASER SYSTEM MODEL LS-40
2
Cleared 510(K)
K
10
0078
MODIFIED STRAIGHT FIRE LASER FIBER
2
Cleared 510(K)
K
08
2230
VECTRA PLUS LASER SYSTEM AND ACCESSORIES
2
Cleared 510(K)
K
09
3162
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)
K
09
3502
VARI-LASE ENDOVENOUS LASER CONSOLE
2
Cleared 510(K)
K
09
0312
TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC
2
Cleared 510(K)
K
08
2586
LIGHTWAVE PROFESSIONAL DELUXE
2
Cleared 510(K)
K
09
0820
TRIA HAIR REMOVAL LASER SYSTEM
2
Cleared 510(K)
K
09
3691
ACCUMAX
2
Cleared 510(K)
K
09
2964
COOLTOUCH VARIA ND:YAG LASER SYSTEM
2
Cleared 510(K)
K
09
1746
WATERLASE MD, MODEL 7100102
2
Cleared 510(K)
K
09
2660
SIROLASER ADVANCE
2
Cleared 510(K)
K
08
3123
MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES
2
Cleared 510(K)
K
09
3451
OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP
2
Cleared 510(K)
K
09
0195
PALOMAR LUX1540 HANDPIECE
2
Cleared 510(K)
K
09
2735
GREENLIGHT XPS LASER SYSTEM
2
Cleared 510(K)
K
09
1625
EPICARE-DUO LASER SYSTEM
2
Cleared 510(K)
K
09
1115
ECO2 LASER SYSTEM
2
Cleared 510(K)
K
09
3251
OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM
2
Cleared 510(K)
K
09
2197
PHOTEX30 DIODE LASER SERIES: 980, 810, 940
2
Cleared 510(K)
K
08
3927
WATERLASE MD
2
Cleared 510(K)
K
09
1800
LIPOEZE LASER ASSISTED ASPIRATION CANNULA
2
Cleared 510(K)
K
09
1562
DOCTOR SMILE A-810 AND B-980 LASERS
2
Cleared 510(K)
K
09
1537
CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTH
2
Cleared 510(K)
K
09
0762
LEDA
2
Cleared 510(K)
K
09
1320
SPECTRA SP II, SPECTRA DENTA II
2
Cleared 510(K)
K
09
1059
FOXQ 980 LASER
2
Cleared 510(K)
K
09
0571
ALMA LASERS ALEX755 MODULE
2
Cleared 510(K)
K
09
1796
SOFTLASE PRO, ORTHOLASE AND HYGIENELASE
2
Cleared 510(K)
K
09
1666
PASCAL PHOTOCOAGULATOR, PASCAL-US
2
Cleared 510(K)
K
09
1922
WATERLASE C100, MODEL 7100104
2
Cleared 510(K)
K
09
1909
LITHO LASER SYSTEM
2
Cleared 510(K)
K
09
0126
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)
K
09
0164
CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER
2
Cleared 510(K)
K
09
1551
VARI-LASE PLATINUM BRIGHT TIP LASER FIBER
2
Cleared 510(K)
K
09
0962
CYBER SURGICAL LASER FAMILY INCLUDING: CYBER TM, CYBER GREEN, CYBER GREEN TM
2
Cleared 510(K)
K
08
3616
PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS
2
Cleared 510(K)
K
09
1323
MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200)
2
Cleared 510(K)
K
09
0776
MEGAPULSE LASER SYSTEM AND FIBERS
2
Cleared 510(K)
K
08
3899
REVLITE Q-SWITCHED ND:YAG LASER SYSTEM
2
Cleared 510(K)
K
09
0094
ZELTIQ SYSTEM
2
Cleared 510(K)
K
08
3253
LOTUS II PULSED ER: YAG LASER SYSTEM
2
Cleared 510(K)
K
09
1169
ELITE MPX LASER SYSTEM WITH CRYO C
2
Cleared 510(K)
K
08
3733
LUME 2 SYSTEM, MODEL GA0005000
2
Cleared 510(K)
K
08
1509
MONTERIS MEDICAL AUTOLITT LASER PROBE
2
Cleared 510(K)
K
08
3203
HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM
2
Cleared 510(K)
K
08
3889
FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY
2
Cleared 510(K)
K
09
0618
CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C
2
Cleared 510(K)
K
09
0297
BLUESHINE GOLD SERIES
2
Cleared 510(K)
K
08
3848
ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM
2
Cleared 510(K)
K
08
3215
INCISIVE FAMILY OF INPULSE ND:YAG LASERS
2
Cleared 510(K)
K
09
0410
COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY
2
Cleared 510(K)
K
08
2039
SYNCHRO HP PLATFORM
2
Cleared 510(K)
K
08
1424
AFFIRM CO2 AND AFFIRM CO2 HP
2
Cleared 510(K)
K
09
0235
ELITE MPX LASER SYSTEM WITH XPL HANDPIECE
2
Cleared 510(K)
K
08
3478
SMOOTHLIPO
2
Cleared 510(K)
K
08
3142
PICASSO LASER SYSTEM
2
Cleared 510(K)
K
09
0084
ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE
2
Cleared 510(K)
K
09
0281
ACCUTECH FAMILY OF POWERFLEX LASER DELIVERY DEVICES
2
Cleared 510(K)
K
08
3900
ERBIUM FRACTIONAL HANDPIECE
2
Cleared 510(K)
K
08
1541
DERMABLATE EFFECT
2
Cleared 510(K)
K
08
3165
PALOMAR ASPIRE LASER PLATFORM
2
Cleared 510(K)
K
08
3500
MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE
2
Cleared 510(K)
K
09
0181
WATERLASE MD
2
Cleared 510(K)
K
08
2825
ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM
2
Cleared 510(K)
K
08
3034
FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F
2
Cleared 510(K)
K
08
2407
MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM
2
Cleared 510(K)
K
08
3918
ATL CO2 MEDICAL LASER SYSTEMS, MODELS ATL-150 AND ATL-250
2
Cleared 510(K)
K
08
3748
IPULSE, MODEL: I150
2
Cleared 510(K)
K
08
3258
MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE
2
Cleared 510(K)
K
08
3915
ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC
2
Cleared 510(K)
K
08
3795
CYNOSURE SMARTLIPO MPX LASER
2
Cleared 510(K)
K
08
2409
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)
K
08
3082
MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS
2
Cleared 510(K)
K
08
3730
ISOLAZ
2
Cleared 510(K)
K
08
3682
180W CERELAS D 980NM DIODE LASER, MODEL D180
2
Cleared 510(K)
K
08
3613
QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY
2
Cleared 510(K)
K
08
3476
NOVEON MODEL LS1100-03
2
Cleared 510(K)
K
08
2938
EZLASE
2
Cleared 510(K)
K
08
2911
SMOOTHCOOL HR SYSTEM
2
Cleared 510(K)
K
08
2809
ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM
2
Cleared 510(K)
K
08
3272
SKINCLEAR Q-SWITCHED ND:YAG LASER
2
Cleared 510(K)
K
08
3379
CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE
2
Cleared 510(K)
K
08
1095
PROLITE III TOWER AND PR AND HR HANDPIECE
2
Cleared 510(K)
K
08
2423
NO!NO! SKIN
2
Cleared 510(K)
K
08
2225
15W CERALAS D 1470NM DIODE LASER, MODEL D1470
2
Cleared 510(K)
K
08
3207
ULTRAWAVE III EX 1320
2
Cleared 510(K)
K
08
0591
TANDA SKINCARE SYSTEM, MODEL: PTSCS
2
Cleared 510(K)
K
08
3069
EZLASE 10W
2
Cleared 510(K)
K
08
2876
BEAMAX/ FORMAX PULSED LIGHT DEVICE FAMILY
2
Cleared 510(K)
K
08
2101
LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE
2
Cleared 510(K)
K
08
2721
LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS
2
Cleared 510(K)
K
08
2263
CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980
2
Cleared 510(K)
K
08
2298
FLASH N' GO
2
Cleared 510(K)
K
08
1352
PROFILE MULTI-PLATFORM SYSTEM
2
Cleared 510(K)
K
08
1408
ELLIPSE MULTIFLEX
2
Cleared 510(K)
K
08
2928
STRAIGHT FIRE HOLMIUM LASER FIBER
2
Cleared 510(K)
K
08
2445
CURATIVE980 DIODE LASER
2
Cleared 510(K)
K
08
2232
EVIS MD PLANTIUM BLUE
2
Cleared 510(K)
K
08
2247
EVIS MD PLATINUM RED LIGHT THERAPY
2
Cleared 510(K)
K
08
2096
POWERLIPO LASER SYSTEM
2
Cleared 510(K)
K
07
3022
CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830
2
Cleared 510(K)
K
07
3000
LUMAPROBE
2
Cleared 510(K)
K
08
2004
SMOOTHKIT+
2
Cleared 510(K)
K
08
0382
SELLAS
2
Cleared 510(K)
K
08
0638
CLARO
2
Cleared 510(K)
K
07
3572
MATRIX RF APPLICATOR
2
Cleared 510(K)
K
08
1704
SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS
2
Cleared 510(K)
K
08
1744
PASCAL SYNTHESIS DELIVERY SYSTEM
2
Cleared 510(K)
K
07
3317
STARLIGHT, MODEL PD9012
2
Cleared 510(K)
K
08
1652
CLAROS NANO DENTAL LASER SYSTEM
2
Cleared 510(K)
K
07
3158
SCULPTURE 2.94 ER:YAG SYSTEM
2
Cleared 510(K)
K
07
3427
MEDILAS D FAMILY LASERS
2
Cleared 510(K)
K
08
0530
MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE
2
Cleared 510(K)
K
08
1939
OMNIGUIDE BEAMPATH FIBER OPTIC HANDPIECE SYSTEM AND STERILIZATION TRAY
2
Cleared 510(K)
K
08
2028
LASERPEEL SOFT-MET MODIFIED ERBIUM LASER
2
Cleared 510(K)
K
08
1457
ATRILAZE LASER ABLATION SYSTEM
2
Cleared 510(K)
K
07
1687
FAMILI OF IRIDEX IQ LASER SYSTEMS
2
Cleared 510(K)
K
08
2033
NANNOLIGHT INTENSE PULSED LIGHT SYSTEM
2
Cleared 510(K)
K
08
0463
ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES
2
Cleared 510(K)
K
08
1619
CHROMOLITE EP
2
Cleared 510(K)
K
08
0731
PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE
2
Cleared 510(K)
K
08
0975
FENCER 308 EXCIMER LASER SYSTEM
2
Cleared 510(K)
K
07
3074
KEY LASER III 1243 US WITH DETECT
2
Cleared 510(K)
K
08
1015
CERALAS D 980NM DIODE LASER, MODELS D15 AND D25
2
Cleared 510(K)
K
08
0496
MOSAIC ECO2 LASER SYSTEM
2
Cleared 510(K)
K
08
0915
FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES
2
Cleared 510(K)
K
08
1219
APOLLO MINI IPL SYSTEM
2
Cleared 510(K)
K
08
0959
DORNIER MEDILAS D 30 LASER, MEDILAS D 1064
2
Cleared 510(K)
K
07
2182
ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060
2
Cleared 510(K)
K
08
1612
AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS
2
Cleared 510(K)
K
08
1628
MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO
2
Cleared 510(K)
K
08
1578
ACCELA SYSTEM
2
Cleared 510(K)
K
08
0244
PALOMAR LUX 1540 HANDPIECE
2
Cleared 510(K)
K
08
1324
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS
2
Cleared 510(K)
K
08
1589
WATERLASE, VERSION 3.0
2
Cleared 510(K)
K
08
0932
MOSAIC LASER SYSTEM
2
Cleared 510(K)
K
08
1416
PALOMAR ASPIRE LASER PLATFORM
2
Cleared 510(K)
K
07
2564
ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM
2
Cleared 510(K)
K
08
0374
BIOSYAG MEDICAL SYSTEM
2
Cleared 510(K)
K
08
1214
STYLA MICROLASER AND STYLAORTHO
2
Cleared 510(K)
K
07
3411
LITEDUO
2
Cleared 510(K)
K
07
3477
PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS
2
Cleared 510(K)
K
08
1181
SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER
2
Cleared 510(K)
K
08
0118
ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE
2
Cleared 510(K)
K
07
3404
IFS LASER SYSTEM
2
Cleared 510(K)
K
08
0248
SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECES
2
Cleared 510(K)
K
07
3715
ELIPO
2
Cleared 510(K)
K
07
2682
50W CERALAS D 1950NM DIODE LASER
2
Cleared 510(K)
K
08
0525
COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W
2
Cleared 510(K)
K
08
0567
PALOMAR ASPIRE LASER PLATFORM
2
Cleared 510(K)
K
08
0163
COOLTOUCH MODELS LC215 AND COOLLIPO
2
Cleared 510(K)
K
07
3617
PHARAON LIPO
2
Cleared 510(K)
K
08
0697
SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER
2
Cleared 510(K)
K
08
0735
CRYOMINI
2
Cleared 510(K)
K
07
3534
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS
2
Cleared 510(K)
K
08
0104
VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7542
2
Cleared 510(K)
K
07
3583
MODIFICATION TO PALOMAR LUX1540 HANDPIECE
2
Cleared 510(K)
K
08
0406
IPULSE, MODEL I400
2
Cleared 510(K)
K
07
3659
XTRAC ULTRA 2, MODEL AL10000
2
Cleared 510(K)
K
07
0355
FOTONA FIDELIS III ER:YAG/ND:YAG LASER SYSTEM FAMILY
2
Cleared 510(K)
K
08
0006
AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE
2
Cleared 510(K)
K
07
3549
Q-PLUS T
2
Cleared 510(K)
K
07
3048
PETERIO UNIVERSAL LASER SCANNING HANDPIECE
2
Cleared 510(K)
K
07
3063
15W CERALAS D 1470NM DIODE LASER
2
Cleared 510(K)
K
07
3322
FOX 1-980, FOX Q-1064, FOX-Q-810
2
Cleared 510(K)
K
07
1896
FOX 940, MODEL 940
2
Cleared 510(K)
K
07
3332
V-RASER DIODE LASER SYSTEM
2
Cleared 510(K)
K
07
1363
WATERLASE AND WATERLASE MD
2
Cleared 510(K)
K
05
3527
SPECTRA HAIR REMOVAL LASER
2
Cleared 510(K)
K
08
0121
CYNOSURE SMARTLIPO MULTIWAVLENGTH LASER
2
Cleared 510(K)
K
07
1734
WATERLASE MD DERM
2
Cleared 510(K)
K
07
2833
P-NAIN SYSTEM
2
Cleared 510(K)
K
07
2779
CERALAS D 980NM DIODE LASER, MODELS D15 AND D25
2
Cleared 510(K)
K
07
3496
OPTILITE HOLMIUM LASER FIBERS
2
Cleared 510(K)
K
07
3464
ANGIODYNAMICS, INC., NEVERTOUCH II 400UM FIBER AND VENACURE PROCEDURE KIT
2
Cleared 510(K)
K
07
2906
SILK'N
2
Cleared 510(K)
K
07
1883
IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 SERIES 2, Q4 SERIES 2
2
Cleared 510(K)
K
07
2925
CANDELA-INOLASE SERENITY PRO PSF SYSTEM
2
Cleared 510(K)
K
07
2332
VARI-LASE WIRE FIBER
2
Cleared 510(K)
K
07
2331
RADIANCY MISTRAL DEVICE
2
Cleared 510(K)
K
07
3313
MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP
2
Cleared 510(K)
K
07
2751
COOLTOUCH MODELS NS 160 AND LC215 COOLIPO
2
Cleared 510(K)
K
07
3436
SPECTRA VRMII 1-SWITCHED ND:YAG LASER SYSTEM
2
Cleared 510(K)
K
07
2484
CYNOSURE YAG FAMILY LASER
2
Cleared 510(K)
K
07
2159
SMART CO2 (SMARTXIDE, SMART US20D) WITH DOT SCANNER
2
Cleared 510(K)
K
07
2995
TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER
2
Cleared 510(K)
K
07
3409
OMNIGUIDE STERILE WAVEGUIDE ADAPTER SYSTEM
2
Cleared 510(K)
K
07
3394
SMARTLIPO LASER
2
Cleared 510(K)
K
07
3300
MILESMAN PREMIUM
2
Cleared 510(K)
K
07
2344
APL MEDICAL SYSTEM
2
Cleared 510(K)
K
07
1815
NOVEON, MODEL LS1100-01-0968
2
Cleared 510(K)
K
07
2868
ACCOLADE II LASER
2
Cleared 510(K)
K
07
1768
ERBIUM FRACTIONAL HANDPIECE
2
Cleared 510(K)
K
07
1051
FRAXEL III SR LASER SYSTEM AND ACCESSORIES
2
Cleared 510(K)
K
07
2262
GENTLERAY 980 DIODE LASER SYSTEM
2
Cleared 510(K)
K
07
2767
QUASAR BLUE LIGHT THERAPY SYSTEM
2
Cleared 510(K)
K
07
0870
SKIN CARE LIGHT
2
Cleared 510(K)
K
07
1621
RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES
2
Cleared 510(K)
K
07
2424
COOLTOUCH, MODEL LC215,COOLLIPO
2
Cleared 510(K)
K
07
0296
VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM
2
Cleared 510(K)
K
07
2514
VISULAS TRION
2
Cleared 510(K)
K
07
2034
DIODE MEDICAL LASER FAMILY, MODELS 4, 6, 30
2
Cleared 510(K)
K
07
2023
ELLIPSE JUVIA, MODEL 9EJU7465
2
Cleared 510(K)
K
07
1328
VISUALASE THERMAL THERAPY SYSTEM
2
Cleared 510(K)
K
07
2106
150W CERALAS D 980NM DIODE LASER
2
Cleared 510(K)
K
07
0185
TANDA SKINCARE SYSTEM, PLC-001, TANDA BLUE, 414-001, TANDA RED, 660-001
2
Cleared 510(K)
K
07
1469
INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM
2
Cleared 510(K)
K
07
1943
SERENITY PRO PSF SYSTEM
2
Cleared 510(K)
K
07
1959
ANGIODYNAMICS, INC.NEVERTOUCH 600UM FIBER AND VENACURE PROCEDURE KIT
2
Cleared 510(K)
K
07
1451
TATTOOSTAR Y
2
Cleared 510(K)
K
06
3427
LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM
2
Cleared 510(K)
K
07
0392
MOSAIC LASER SYSTEM
2
Cleared 510(K)
K
07
0805
ULTRAWAVE II EX 1320
2
Cleared 510(K)
K
07
0298
MODIFICATION TO PALOMAR LUXIR HANDPIECE
2
Cleared 510(K)
K
07
0924
FLEXGUARD
2
Cleared 510(K)
K
07
1152
PALOMAR ERBIUM HANDPIECE
2
Cleared 510(K)
K
07
0536
MEDILAS D FAMILY LASERS
2
Cleared 510(K)
K
07
0284
FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM)
2
Cleared 510(K)
K
07
1295
100W CERALAS D 980NM DIODE LASER
2
Cleared 510(K)
K
06
3104
FOX MEDICAL DIODE LASER SYSTEM 810NM
2
Cleared 510(K)
K
07
0388
PROFILE MULTI-PLATFORM SYSTEM
2
Cleared 510(K)
K
07
0353
KELSEY INTERSITITAL LASER THERAPY SYSTEM
2
Cleared 510(K)
K
07
0494
EPI-C PLUS
2
Cleared 510(K)
K
06
3808
FRAXEL IV SR LASER SYSTEM
2
Cleared 510(K)
K
06
3038
FRAXEL III SR LASER SYSTEM AND ACCESSORIES
2
Cleared 510(K)
K
07
0466
REVOLIX DUO LASER SYSTEM
2
Cleared 510(K)
K
06
2963
PHAROS EXCIMER LASER SYSTEM, MODEL EX-308
2
Cleared 510(K)
K
07
0138
CUTERA ER:YAG LASER HANDPIECE
2
Cleared 510(K)
K
06
3867
CUTERA ER:YSGG LASER HANDPIECE
2
Cleared 510(K)
K
07
0476
REVOLIX 120
2
Cleared 510(K)
K
06
2258
GENESIS DIODE LASER
2
Cleared 510(K)
K
07
0216
VARI-LASE BRIGHT TIP FIBER
2
Cleared 510(K)
K
06
3384
DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980
2
Cleared 510(K)
K
06
1489
ATRILAZE MI SURGICAL ABLATION SYSTEM
2
Cleared 510(K)
K
07
0378
ANGIODYNAMICS, INC. 600UM FIBER AND VENACURE PROCEDURE KIT
2
Cleared 510(K)
K
06
3152
CLAROS DENTAL LASER SYSTEM
2
Cleared 510(K)
K
06
3001
SLIM EVOLUTION FAMILY OF CO2 LASERS AND DELIVERY DEVICE ACCESSORIES
2
Cleared 510(K)
K
06
3698
CO2 LASER SYSTEM, MODEL C-LAS
2
Cleared 510(K)
K
06
2762
DERMA YAG
2
Cleared 510(K)
K
06
1652
PALOMAR LUX1540 HANDPIECE
2
Cleared 510(K)
K
06
3682
INTRALASE FUSION LASER
2
Cleared 510(K)
K
06
3571
PALOMAR LUX2940 HANDPIECE
2
Cleared 510(K)
K
06
3800
CANDELA FLUORESCENT PULSED LIGHT SYSTEM
2
Cleared 510(K)
K
06
3715
JUNIPER COOLING DEVICE XTRA
2
Cleared 510(K)
K
07
0157
OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER
2
Cleared 510(K)
K
06
2303
FRAXEL II SR LASER SYSTEM
2
Cleared 510(K)
K
06
1720
COSMELIGHT
2
Cleared 510(K)
K
07
0063
YAG MIR II LASER
2
Cleared 510(K)
K
06
1898
EZLASE
2
Cleared 510(K)
K
07
0071
OMNIGUIDE ZERO FLOW ZF-T WAVEGUIDE FIBER
2
Cleared 510(K)
K
06
3828
DIOMED DELTA 25
2
Cleared 510(K)
K
06
3834
REVLITE C6 Q-SWITCHED ND:YAG LASER SYSTEM
2
Cleared 510(K)
K
06
3396
VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES
2
Cleared 510(K)
K
06
3249
BEAMAX
2
Cleared 510(K)
K
06
2363
BWF-5 MEDICAL LASER SERIES, 810 NM; 930 NM; 980 NM; 1080 NM
2
Cleared 510(K)
K
06
3074
CANDELA 3630 LASER SYSTEM
2
Cleared 510(K)
K
06
2314
HORUS LASER KERATOME
2
Cleared 510(K)
K
06
3072
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND 1064 ND:YAG HANDPIECE ACCESSORIES
2
Cleared 510(K)
K
06
3073
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS
2
Cleared 510(K)
K
06
1656
LASER-D68
2
Cleared 510(K)
K
06
1436
PALOMAR Q-YAG 5 ND:YAG LASER SYSTEM
2
Cleared 510(K)
K
06
3112
REVLITE Q-SWITCHED ND:YAG LASER
2
Cleared 510(K)
K
06
2719
GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES
2
Cleared 510(K)
K
06
2589
SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM
2
Cleared 510(K)
K
06
3141
OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER
2
Cleared 510(K)
K
06
3060
BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP
2
Cleared 510(K)
K
06
2822
VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7500
2
Cleared 510(K)
K
06
2721
GREENTON ECOLITE IPL SYSTEM
2
Cleared 510(K)
K
06
2871
LUMACARE LC-122M NON-COHERENT LIGHT SOURCE
2
Cleared 510(K)
K
06
2619
DENLASER 800 PLUS
2
Cleared 510(K)
K
06
2369
IRIDEX OCULIGHT TX
2
Cleared 510(K)
K
06
2321
SMARTLIPO ND:YAG LASER
2
Cleared 510(K)
K
06
0653
THERMACLEAR
2
Cleared 510(K)
K
06
2336
OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE
2
Cleared 510(K)
K
06
2312
AXIOM PULSED LIGHT SYSTEM
2
Cleared 510(K)
K
06
1850
MINI-YAG LASER
2
Cleared 510(K)
K
06
2071
PROMETEY, MODEL G1-03
2
Cleared 510(K)
K
06
1966
LITETOUCH DENTAL LASER SYSTEM
2
Cleared 510(K)
K
06
0787
TATTOOSTAR FAMILY
2
Cleared 510(K)
K
06
2210
COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160
2
Cleared 510(K)
K
06
1618
COOLTOUCH, MODEL CTEV
2
Cleared 510(K)
K
06
2423
OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM
2
Cleared 510(K)
K
06
2048
AESTHERA PHOTOPNEUMATIC (PPX) SYSTEM
2
Cleared 510(K)
K
05
3540
INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE
2
Cleared 510(K)
K
06
2248
AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM
2
Cleared 510(K)
K
06
0372
INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3
2
Cleared 510(K)
K
06
1455
DORNIER MEDILAS H 20 LASER
2
Cleared 510(K)
K
06
0966
COOLTOUCH VARIA ND:YAG LASER SYSTEM
2
Cleared 510(K)
K
06
1470
DEL SOL BLUE LIGHT THERAPY SYSTEM
2
Cleared 510(K)
K
06
1909
HIGHLAND BEAM DELIVERY SYSTEM, MODEL 3-099-002-00-00
2
Cleared 510(K)
K
06
1366
DENLASER 800 PLUS
2
Cleared 510(K)
K
06
0448
LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE.
2
Cleared 510(K)
K
05
2354
OCULASE MD
2
Cleared 510(K)
K
06
1117
NANOLITE SKIN CARE SYSTEM
2
Cleared 510(K)
K
06
1178
ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT
2
Cleared 510(K)
K
06
0905
IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1
2
Cleared 510(K)
K
06
0407
JUNIPER COOLING DEVICE
2
Cleared 510(K)
K
06
0752
ACMI DUR-HL LASER SYSTEMS
2
Cleared 510(K)
K
06
0977
MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523
2
Cleared 510(K)
K
05
1442
PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT
2
Cleared 510(K)
K
06
0516
ELLIPSE 12PL, MODEL 9ESL7228
2
Cleared 510(K)
K
05
2371
DEPILITE EL-8B SERIES DERMO FLASH SYSTEMS
2
Cleared 510(K)
K
06
0567
SPECTRAGENICS ATS-1
2
Cleared 510(K)
K
06
0680
ATRILAZE SURGICAL ABLATION SYSTEM
2
Cleared 510(K)
K
06
0114
VECTRA LASER SYSTEM
2
Cleared 510(K)
K
05
3628
LIGHTSHEER DUET LASER SYSTEM
2
Cleared 510(K)
K
06
0326
LASERTX - DIODE LASER & DELIVERY SYSTEM
2
Cleared 510(K)
K
06
0310
FRAXEL II SR LASER SYSTEM AND ACCESSORIES
2
Cleared 510(K)
K
06
0301
PALOMAR LUX1540 HANDPIECE
2
Cleared 510(K)
K
06
0411
RADIANCY CLEARTOUCH LITE ACNE CLEARANCE SYSTEM
2
Cleared 510(K)
K
06
0304
PHOTEX DIODE LASER SERIES, MODELS 980, 810 AND 940
2
Cleared 510(K)
K
06
0459
QUADROSTAR 980
2
Cleared 510(K)
K
06
0457
QUADROSTAR 532
2
Cleared 510(K)
K
06
0455
MULTISTAR
2
Cleared 510(K)
K
05
3047
FRAXEL SR LASER SYSTEM
2
Cleared 510(K)
K
06
0216
ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM
2
Cleared 510(K)
K
05
2777
LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D
2
Cleared 510(K)
K
06
0234
MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM
2
Cleared 510(K)
K
05
2310
CRYOFLOW 700, CRYOFLOW 1000
2
Cleared 510(K)
K
05
3616
POLARIS WR, ST APPLICATOR
2
Cleared 510(K)
K
05
3511
DA VINCI FEMTOSECOND SURGICAL LASER
2
Cleared 510(K)
K
06
0338
FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO
2
Cleared 510(K)
K
06
0069
PALOMAR LUXIR FRACTIONAL HANDPIECE
2
Cleared 510(K)
K
05
3087
VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM
2
Cleared 510(K)
K
06
0033
PROFILE MULTI-PLATFORM SYSTEM
2
Cleared 510(K)
K
06
0395
CRYO, MODEL V6.0
2
Cleared 510(K)
K
05
3604
WAVELIGHT IDAS
2
Cleared 510(K)
K
05
3139
FOTONA QX ND:YAG/KTP LASER SYSTEM
2
Cleared 510(K)
K
05
3608
CYNOSURE PHOTOGENICA V-STAR LASER
2
Cleared 510(K)
K
04
2114
MDL SERIES DIODE LASERS, MODEL MDL-10/15
2
Cleared 510(K)
K
05
3421
YAG MIR FAMILY LASER
2
Cleared 510(K)
K
05
2991
RADIANCY FACIAL SKINCARE DEVICE
2
Cleared 510(K)
K
05
2442
RADIANCY SKINSTATION WITH PSORIASIS LIGHT UNIT ASSEMBLY
2
Cleared 510(K)
K
06
0050
MEGABEAM SIDEFIBER FIBER OPTIC DELIVERY SYSTEM
2
Cleared 510(K)
K
05
2680
CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES
2
Cleared 510(K)
K
05
3161
SIROLASER
2
Cleared 510(K)
K
05
3324
CHROMOLITE SYSTEM
2
Cleared 510(K)
K
05
1113
QUANTA SYSTEM ETRNA GIOVINEZZA
2
Cleared 510(K)
K
05
2848
SPECTRA HAIR REMOVAL LASER
2
Cleared 510(K)
K
05
3457
VAPORMAX II
2
Cleared 510(K)
K
05
2604
STARLITE 2006
2
Cleared 510(K)
K
05
2688
ELLIPSE FLEX PPT, MODEL 9ESF7255
2
Cleared 510(K)
K
05
2874
SOPRANO HAIR REMOVAL DIODE LASER
2
Cleared 510(K)
K
05
2526
NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES
2
Cleared 510(K)
K
05
2806
BURANE
2
Cleared 510(K)
K
05
2495
ATRILAZE MALLEABLE ABLATION PROBE
2
Cleared 510(K)
K
05
2336
SPECTRAQUATTRO PULSED LIGHT SYSTEM
2
Cleared 510(K)
K
05
1508
MED FLASH II INTENSE PULSED LIGHT SYSTEM.
2
Cleared 510(K)
K
05
1259
VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
2
Cleared 510(K)
K
05
2324
POLARIS LV, LVA APPLICATOR
2
Cleared 510(K)
K
05
0382
AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM
2
Cleared 510(K)
K
05
1876
MULTIWAVE XR
2
Cleared 510(K)
K
05
1671
RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY
2
Cleared 510(K)
K
05
2129
LUMENIS 1000 INTEGRATED SLIT LAMP
2
Cleared 510(K)
K
05
1996
DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 30
2
Cleared 510(K)
K
05
0824
100W CERALAS D 980 LASER SYSTEM, MODEL D100
2
Cleared 510(K)
K
05
1434
COOLTOUCH ND:YAG LASER SYSTEMS, MODELS CT3S AND CTEV
2
Cleared 510(K)
K
05
1428
VTRAC EXCIMER LAMP SYSTEM
2
Cleared 510(K)
K
05
0216
OMNILUX REVIVE AND OMNILUX PLUS
2
Cleared 510(K)
K
05
1287
VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
2
Cleared 510(K)
K
04
1893
INTRALASE FS LASER
2
Cleared 510(K)
K
04
3032
DEALIGHT IPL
2
Cleared 510(K)
K
05
1359
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY
2
Cleared 510(K)
K
05
1268
RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT
2
Cleared 510(K)
K
05
0841
FRAXEL SR LASER SYSTEM
2
Cleared 510(K)
K
05
1255
LUMIPHASE-R
2
Cleared 510(K)
K
05
1399
WAVELIGHT AURIGA
2
Cleared 510(K)
K
05
0779
CYNERGY MULTIPLEX LASER
2
Cleared 510(K)
K
04
2630
REVLIGHT SKIN CARE SYSTEM
2
Cleared 510(K)
K
05
0696
MEDLITE C1 Q-SWITCHED ND:YAG LASER
2
Cleared 510(K)
K
05
0673
CANDELA FAMILY OF PULSE DYE LASER SYSTEMS
2
Cleared 510(K)
K
05
0738
FT FIBER OPTIC DELIVERY SYSTEMS
2
Cleared 510(K)
K
05
1167
REVOLIX AND REVOLIX JR
2
Cleared 510(K)
K
04
3377
ZENO
2
Cleared 510(K)
K
05
0453
ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-00050
2
Cleared 510(K)
K
05
0900
MEDIOSTAR XT
2
Cleared 510(K)
K
05
0672
ERCHONIA EVRL LASER
2
Cleared 510(K)
K
05
0950
MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS
2
Cleared 510(K)
K
05
0274
DIODENT II DENTAL LASER SYSTEM
2
Cleared 510(K)
K
04
1554
AIP INTENSE PULSED LIGHT SYSTEM
2
Cleared 510(K)
K
05
0165
MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100
2
Cleared 510(K)
K
05
0254
SPECTRA-SP CO2 LASER SYSTEM
2
Cleared 510(K)
K
05
0562
OCULIGHT GL/GLX
2
Cleared 510(K)
K
05
0796
AURORA DS, DS APPLICATOR
2
Cleared 510(K)
K
05
0679
CUTERA SOLERA OPUS AESTHETIC PRODUCT
2
Cleared 510(K)
K
05
0047
CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY
2
Cleared 510(K)
K
04
3521
BIOSYAG 50 MED
2
Cleared 510(K)
K
05
0293
FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS
2
Cleared 510(K)
K
05
0021
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
2
Cleared 510(K)
K
04
3329
OMNILUX REVIVE AND BLUE
2
Cleared 510(K)
K
05
0412
VAPORMAX
2
Cleared 510(K)
K
05
0108
SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS
2
Cleared 510(K)
K
04
2319
RELIANT LASER II SYSTEM AND ACCESSORIES
2
Cleared 510(K)
K
05
0452
AURORA SR AND SRA APPLICATOR
2
Cleared 510(K)
K
04
3486
PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01
2
Cleared 510(K)
K
05
0317
BURANE XL
2
Cleared 510(K)
K
04
3575
DERMILLUME, MODEL PRO1000
2
Cleared 510(K)
K
04
3255
ELLIPSE LIGHT SPT
2
Cleared 510(K)
K
05
0218
WAVELIGHT SINON
2
Cleared 510(K)
K
04
3251
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B
2
Cleared 510(K)
K
04
3046
COOLTOUCH, MODEL CT3S
2
Cleared 510(K)
K
05
0069
CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT
2
Cleared 510(K)
K
04
3173
Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES
2
Cleared 510(K)
K
04
0103
SOUNDSKIN PHOTOTHERAPY SYSTEM
2
Cleared 510(K)
K
04
1879
PALOMAR LUX1064 HANDPIECE
2
Cleared 510(K)
K
04
1086
PALOMAR STARLUX PULSED LIGHT SYSTEM
2
Cleared 510(K)
K
04
3429
CYNERGY LASER
2
Cleared 510(K)
K
04
2000
MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS
2
Cleared 510(K)
K
04
3319
CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES
2
Cleared 510(K)
K
04
0270
OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM
2
Cleared 510(K)
K
03
1425
GENTLEWAVES LED PHOTOMODULATION DEVICE
2
Cleared 510(K)
K
04
2785
MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300
2
Cleared 510(K)
K
04
1011
ULTRALIGHT II ND:YAG LASER SYSTEM
2
Cleared 510(K)
K
04
3164
PANALIGHT-BLU, MODEL 4175
2
Cleared 510(K)
K
04
1957
EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS
2
Cleared 510(K)
K
04
0744
ATRILAZE SOFT TISSUE ABLATION SYSTEM
2
Cleared 510(K)
K
04
2968
MCL 30 DERMABLATE ER:YAG LASER SYSTEM
2
Cleared 510(K)
K
04
2918
MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2
2
Cleared 510(K)
K
04
1242
CANDELA SMOOTHBEAM LASER SYSTEM
2
Cleared 510(K)
K
04
3012
OMNIPULSE MINI, MODEL 2120
2
Cleared 510(K)
K
04
1323
PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA
2
Cleared 510(K)
K
04
2211
MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS
2
Cleared 510(K)
K
04
1959
POLARIS DS/COMET
2
Cleared 510(K)
K
04
2496
ADEPT ULTRALITE 532 LASER
2
Cleared 510(K)
K
04
1969
AURORA DS
2
Cleared 510(K)
K
04
1943
XTRAC XL, MODEL AL8000
2
Cleared 510(K)
K
04
0563
LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT)
2
Cleared 510(K)
K
04
2439
AZURYT MODEL CLT 1401, CO2 SURGICAL LASER SYSTEM
2
Cleared 510(K)
K
04
1994
MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM
2
Cleared 510(K)
K
04
1767
COOLCUBE COOLPEN
2
Cleared 510(K)
K
04
2474
ARION
2
Cleared 510(K)
K
04
1739
EDWARDS E360 SURGICAL ABLATION DEVICE
2
Cleared 510(K)
K
04
0921
COOLTOUCH, MODEL NS 160
2
Cleared 510(K)
K
03
2991
LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX
2
Cleared 510(K)
K
04
1930
VARILITE LASER SYSTEM
2
Cleared 510(K)
K
04
2139
VISULAS YAG III
2
Cleared 510(K)
K
04
1660
TRIMEDYNE HOLMIUM LASER SYSTEMS
2
Cleared 510(K)
K
04
1829
FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS
2
Cleared 510(K)
K
04
1419
LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM
2
Cleared 510(K)
K
04
1262
DURALITE-GL
2
Cleared 510(K)
K
04
1721
LVI AESTHETIC LASER
2
Cleared 510(K)
K
04
1710
VERSAWAVE DENTAL ER:YAG LASER SYSTEM
2
Cleared 510(K)
K
04
1103
ACNELIFT
2
Cleared 510(K)
K
03
0290
PERIOLASE ND:YAG DENTAL LASER SYSTEM
2
Cleared 510(K)
K
03
1140
WATERLASE
2
Cleared 510(K)
K
04
1569
CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM0002
2
Cleared 510(K)
K
04
0617
RELIANT LASER SYSTEM II
2
Cleared 510(K)
K
04
0659
MCCUE PLC ENERGIST ULTRA VARIABLE PULSED LIGHT SYSTEM
2
Cleared 510(K)
K
03
2397
DUAL YELLOW LASER, MODEL DUAL YELLOW D10B
2
Cleared 510(K)
K
04
1095
PHOTOSILK PULSED LIGHT SYSTEM
2
Cleared 510(K)
K
04
0433
SINON
2
Cleared 510(K)
K
04
0384
MYDON C
2
Cleared 510(K)
K
04
0424
LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120
2
Cleared 510(K)
K
04
0294
LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 980
2
Cleared 510(K)
K
03
0810
COOLAN 300
2
Cleared 510(K)
K
04
0289
SMARTLITE D FREQUENCY DOUBLED ND:YAG LASER
2
Cleared 510(K)
K
04
0727
CRYO 5
2
Cleared 510(K)
K
04
0131
COOLTOUCH; COOLTOUCH II; AND COOLTOUCH CT3 ND:YAG LASER SYSTEM
2
Cleared 510(K)
K
03
3183
RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0012
2
Cleared 510(K)
K
04
0055
POLYLASE LP
2
Cleared 510(K)
K
03
2797
DELIGHT DENTAL ER: YAG LASER SYSTEM
2
Cleared 510(K)
K
04
0234
LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM
2
Cleared 510(K)
K
04
0081
PALOMAR LUXV HANDPIECE
2
Cleared 510(K)
K
03
3072
LUCENTLITE, MODEL IMD 010
2
Cleared 510(K)
K
03
4011
GEMINI SURGICAL LASER SYSTEM & ACCESSORIES
2
Cleared 510(K)
K
04
0005
PROFILE 2000/3000 LASER SYSTEM
2
Cleared 510(K)
K
04
0156
IFL PROFESSIONAL SYSTEM, MODEL C100
2
Cleared 510(K)
K
03
2863
CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D50
2
Cleared 510(K)
K
03
2864
CERALAS D 810 DIODE LASER SYSTEM, MODEL D15
2
Cleared 510(K)
K
03
3933
POWERLITE 600 EX SYSTEM
2
Cleared 510(K)
K
03
3549
STARLUX PULSED LIGHT SYSTEM
2
Cleared 510(K)
K
03
2459
PROFILE 1320 LASER SYSTEM
2
Cleared 510(K)
K
03
3251
THE FRIENDLYLIGHT ND: YAG LASERS
2
Cleared 510(K)
K
03
3259
LIGHT AGE Q-CLEAR LASER, MODEL 701-1101
2
Cleared 510(K)
K
03
3962
LAD (EPITURE EASYTOUCH), MODEL LAD-08
2
Cleared 510(K)
K
03
3354
FEMTEC LASER MICROKERATOME
2
Cleared 510(K)
K
03
4030
APOGEE ELITE
2
Cleared 510(K)
K
03
0523
WATERLASE
2
Cleared 510(K)
K
03
2514
AC APPLICATOR, AURORA AC
2
Cleared 510(K)
K
03
2667
FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW)
2
Cleared 510(K)
K
03
3176
TRISTAR AESTHETIC WORKSTATION LASER
2
Cleared 510(K)
K
03
3437
SPHINX LASER SYSTEMS
2
Cleared 510(K)
K
03
3461
CANDELA VBEAM PULSE DYE LASER SYSTEM
2
Cleared 510(K)
K
03
3331
CANDELA CBEAM PULSE DYE LASER SYSTEM
2
Cleared 510(K)
K
03
3423
REVOLIX LASER SYSTEMS
2
Cleared 510(K)
K
03
3799
CLINICAL LASETTE P-200
2
Cleared 510(K)
K
03
2944
YA-MAN LASER 21
2
Cleared 510(K)
K
03
2846
SPECTRA PULSED DIODE LASER, MODEL DR-1
2
Cleared 510(K)
K
03
2205
RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY
2
Cleared 510(K)
K
03
3586
MODIFICATION TO AURORA DS
2
Cleared 510(K)
K
03
2735
SPECTRA QT: Q-SWITCHED ND: YAG LASER SYSTEM
2
Cleared 510(K)
K
03
0834
CANDELA SMOOTHBEAM LASER SYSTEM
2
Cleared 510(K)
K
03
1671
POLARIS WR
2
Cleared 510(K)
K
03
2383
MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM
2
Cleared 510(K)
K
03
3237
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE
2
Cleared 510(K)
K
03
2260
ARAMIS II DERMATOLOGICAL LASER
2
Cleared 510(K)
K
03
2539
CYNOSURE PHOTOGENICA SV LASER
2
Cleared 510(K)
K
02
4206
AURA ISURGICAL LASER SYSTEM & ACCESSORIES
2
Cleared 510(K)
K
03
2460
PROFILE BBL SYSTEM
2
Cleared 510(K)
K
03
1795
RELIANT LASER SYSTEM
2
Cleared 510(K)
K
03
3172
CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS
2
Cleared 510(K)
K
03
1819
DIO-DENT 10 DENTAL DIODE LASER
2
Cleared 510(K)
K
03
2599
MEDICAL LASER TECHNOLOGIES, LLC MTL ERBIUM:YAG LASER SYSTEM
2
Cleared 510(K)
K
03
3181
SPR SYSTEM
2
Cleared 510(K)
K
03
2704
INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30
2
Cleared 510(K)
K
03
2703
INNOVATECH STRAIGHT LASER PROBE, MODEL 420-10
2
Cleared 510(K)
K
03
2221
ADEPT 1064/755 LASER
2
Cleared 510(K)
K
03
2220
ADEPT 1064/532 LASER
2
Cleared 510(K)
K
03
2218
ADEPT 1064/532/755 LASER
2
Cleared 510(K)
K
03
2565
CYNOSURE PHOTOGENICA VL
2
Cleared 510(K)
K
03
0539
LASERSMILE
2
Cleared 510(K)
K
03
2357
NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES
2
Cleared 510(K)
K
03
1125
CYNOSURE SMART FILE ND:YAG LASERS
2
Cleared 510(K)
K
03
2085
GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000
2
Cleared 510(K)
K
03
2805
MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
2
Cleared 510(K)
K
03
2023
W.O.M. LASER U100PLUS
2
Cleared 510(K)
K
03
1440
SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER
2
Cleared 510(K)
K
03
1389
CYNOSURE SMART 2940D ER:YAG LASER
2
Cleared 510(K)
K
03
1960
INTRALASE FS LASER
2
Cleared 510(K)
K
03
0846
CANDELA SMOOTHBEAM LASER SYSTEM
2
Cleared 510(K)
K
03
1805
BLU-U, MODEL 4170
2
Cleared 510(K)
K
03
1954
COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS
2
Cleared 510(K)
K
03
2204
MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
2
Cleared 510(K)
K
03
2191
OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM
2
Cleared 510(K)
K
03
1489
PITANGA
2
Cleared 510(K)
K
03
1988
AURORA DS
2
Cleared 510(K)
K
03
1993
AURORA SR
2
Cleared 510(K)
K
03
1451
XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL7000
2
Cleared 510(K)
K
03
0033
LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES
2
Cleared 510(K)
K
03
0426
OMNILUX RED
2
Cleared 510(K)
K
03
0342
LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS
2
Cleared 510(K)
K
03
1690
CYNOSURE YAG FAMILY LASER (PHOTOGENICA YAG AND ACCLAIM)
2
Cleared 510(K)
K
03
1258
CYNOSURE PHOTOLIGHT PL
2
Cleared 510(K)
K
02
4204
FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM
2
Cleared 510(K)
K
03
1680
SPECTRAPULSE
2
Cleared 510(K)
K
02
4259
PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300
2
Cleared 510(K)
K
02
4189
NLITE SYSTEM, MODEL#: A00-1025/A00-1033
2
Cleared 510(K)
K
03
0897
SKINSTATION
2
Cleared 510(K)
K
02
4093
MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS
2
Cleared 510(K)
K
03
1233
ANDIODYNAMICS, INC. ELVS PROCEDURE KIT
2
Cleared 510(K)
K
03
0883
OMNILUX BLUE
2
Cleared 510(K)
K
03
0654
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
2
Cleared 510(K)
K
02
3881
PROFILE 1064 LASER SYSTEM
2
Cleared 510(K)
K
03
1488
CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASER
2
Cleared 510(K)
K
03
0700
CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT
2
Cleared 510(K)
K
03
1317
SMART 2940 D ER: YAG LASER
2
Cleared 510(K)
K
03
1184
COOL TOUCH 3
2
Cleared 510(K)
K
03
0805
MYTHOS 500
2
Cleared 510(K)
K
03
0527
LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS
2
Cleared 510(K)
K
03
0508
DEPILASE TRIO LASE LASER SYSTEM
2
Cleared 510(K)
K
03
0510
DEPILASE TWIN YAG LASER SYSTEM
2
Cleared 510(K)
K
03
0480
L600 HAIR REMOVAL
2
Cleared 510(K)
K
03
0453
COOLTOUCH ND: YAG LASER SYSTEM
2
Cleared 510(K)
K
03
1224
SMARTXIDE
2
Cleared 510(K)
K
03
0506
DEPILASE YAG LASE PLUS LASER SYSTEM
2
Cleared 510(K)
K
03
0423
POWERLITE 600 EP SYSTEM
2
Cleared 510(K)
K
02
3734
ARAMIS II DERMATOLOGICAL LASER
2
Cleared 510(K)
K
03
0959
BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100
2
Cleared 510(K)
K
03
0235
F1 DIODE LASER SYSTEM
2
Cleared 510(K)
K
03
0181
INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM
2
Cleared 510(K)
K
03
0147
LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS
2
Cleared 510(K)
K
02
3547
DIOLASE 980 D LASER SYSTEM
2
Cleared 510(K)
K
03
0186
POLRIS LV
2
Cleared 510(K)
K
02
4371
CANDELA GENTLE LASE FAMILY OF LASER SYSTEM
2
Cleared 510(K)
K
02
3257
ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX
2
Cleared 510(K)
K
02
4260
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
2
Cleared 510(K)
K
02
3954
ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES
2
Cleared 510(K)
K
02
2923
CANDELA GENTLE YAG LASER SYSTEM
2
Cleared 510(K)
K
02
4335
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
2
Cleared 510(K)
K
02
4061
PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00
2
Cleared 510(K)
K
02
3899
DUAL YELLOW LASER, MODEL D10B
2
Cleared 510(K)
K
02
2709
MEDLITE Q-SWITHCED LASER
2
Cleared 510(K)
K
03
0338
ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002
2
Cleared 510(K)
K
02
4064
POLARIS DS
2
Cleared 510(K)
K
02
2807
MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA
2
Cleared 510(K)
K
02
3967
PALOMAR Q-YAG ND:YAG LASER SYSTEM
2
Cleared 510(K)
K
02
3624
SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921
2
Cleared 510(K)
K
02
2951
CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG
2
Cleared 510(K)
K
02
2341
TERABYTE 2000 HAIR REMOVER
2
Cleared 510(K)
K
02
2884
CANDELA SMOOTHBEAM LASER SYSTEM
2
Cleared 510(K)
K
02
3464
VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR
2
Cleared 510(K)
K
02
1222
LAD, MODEL LAD-01
2
Cleared 510(K)
K
02
4088
CERALAS D 980 LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT, MODEL: D15 AND D25
2
Cleared 510(K)
K
02
2466
PROFILE 1320 LASER SYSTEM
2
Cleared 510(K)
K
02
3962
NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-160
2
Cleared 510(K)
K
02
3193
CANDELA GENTLE YAG LASER SYSTEM
2
Cleared 510(K)
K
02
2607
SPECTRAPULSE
2
Cleared 510(K)
K
02
3081
PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION)
2
Cleared 510(K)
K
02
3041
W.O.M. LASER U100
2
Cleared 510(K)
K
02
1548
FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM
2
Cleared 510(K)
K
02
3543
EVLT KIT AND D15PLUS AND D30PLUS DIODE
2
Cleared 510(K)
K
02
2839
FOTONA DUALIS PLUS ND:YAG LASER SYSTEM
2
Cleared 510(K)
K
02
2837
FOTONA TANDEM LASER SYSTEM
2
Cleared 510(K)
K
02
2838
FOTONA DUALIS ER:YAG/KTP LASER SYSTEM
2
Cleared 510(K)
K
02
2817
COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II
2
Cleared 510(K)
K
02
2464
EQUILASE SYSTEM
2
Cleared 510(K)
K
02
1444
CYNOSURE PHOTOGENICA SV
2
Cleared 510(K)
K
02
2760
MILLENNIUM MICROSURGICAL SYSTEM
2
Cleared 510(K)
K
02
2655
TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH
2
Cleared 510(K)
K
02
2610
CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160
2
Cleared 510(K)
K
02
2583
FLASH 1
2
Cleared 510(K)
K
02
2060
LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE ACCESSORIES
2
Cleared 510(K)
K
02
0339
DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEM
2
Cleared 510(K)
K
02
3182
INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS
2
Cleared 510(K)
K
02
2381
PROFILE 1320 LASER SYSTEM
2
Cleared 510(K)
K
02
2378
PLASMALITE PULSED LIGHT SYSTEM
2
Cleared 510(K)
K
02
2351
DIODENT DENTAL LASER SYSTEM
2
Cleared 510(K)
K
02
2338
OPTICAL INTEGRITY GENERAL SHAPED FIBER
2
Cleared 510(K)
K
02
2327
NOVUS SPECTRA
2
Cleared 510(K)
K
02
0839
QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, VX, DL
2
Cleared 510(K)
K
02
2228
FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES
2
Cleared 510(K)
K
02
2226
ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS
2
Cleared 510(K)
K
01
4128
CANDELA SMOOTHBEAM LASER SYSTEM
2
Cleared 510(K)
K
02
2266
AURORA SR
2
Cleared 510(K)
K
02
2181
NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES
2
Cleared 510(K)
K
01
3974
RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A
2
Cleared 510(K)
K
02
1975
LASERSYSTEM BEAUTYSTAR 532
2
Cleared 510(K)
K
02
1946
CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEM
2
Cleared 510(K)
K
02
1848
CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, 1160
2
Cleared 510(K)
K
02
2568
PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIR
2
Cleared 510(K)
K
02
2569
PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONS
2
Cleared 510(K)
K
02
2544
DORNIER MEDILAS H LASER FIBER CABLES
2
Cleared 510(K)
K
02
1696
20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25
2
Cleared 510(K)
K
02
1686
LASER FIBER GF500
2
Cleared 510(K)
K
02
1724
DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS
2
Cleared 510(K)
K
02
1650
ATHOSCAN FOR THE ATHOS LASER CONSTANS COOLING HAND PIECE FOR THE ATHOS LASER
2
Cleared 510(K)
K
01
3623
CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 420
2
Cleared 510(K)
K
01
3691
CERALAS D DIODE LASER SYSTEM, MODEL # D50
2
Cleared 510(K)
K
02
1550
LUMENIS SELECTA DUET
2
Cleared 510(K)
K
02
1508
OPUSDUO EC DENTAL LASER SYSTEM
2
Cleared 510(K)
K
02
1304
PROLITE PULSED LIGHT SYSTEM
2
Cleared 510(K)
K
02
1616
DELIGHT DENTAL ER: YAG LASER SYSTEM
2
Cleared 510(K)
K
02
1149
AURORA DS
2
Cleared 510(K)
K
02
1180
CANDELA VBEAM PULSED DYE LASER SYSTEM
2
Cleared 510(K)
K
02
0021
LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION)
2
Cleared 510(K)
K
02
1227
SOFTLASE G2-SURGICAL DIODE LASER SYSTEM
2
Cleared 510(K)
K
02
0958
CANDELA CBEAM PULSED DYE LASER SYSTEM
2
Cleared 510(K)
K
02
0941
PALOMAR LUXG HANDPIECE
2
Cleared 510(K)
K
02
0856
SPATOUCH PHOTOEPILATION SYSTEM
2
Cleared 510(K)
K
02
0835
CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60
2
Cleared 510(K)
K
02
0729
NLITE SYSTEM,MODEL A00-1051
2
Cleared 510(K)
K
01
4040
FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS
2
Cleared 510(K)
K
02
0673
WAVE FORM MANUFACTURING PROLASE GENERAL SHAPED FIBER
2
Cleared 510(K)
K
01
3021
LIGHTLANCE LASER SKIN PERFORATOR
2
Cleared 510(K)
K
02
0849
APEX 800 LASER SYSTEM, MODEL APEX 800
2
Cleared 510(K)
K
02
0847
XTRAC EXCIMER LASER SYSTEM, MODEL AL7000
2
Cleared 510(K)
K
02
0513
EPY-50
2
Cleared 510(K)
K
02
0453
PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER
2
Cleared 510(K)
K
01
3300
MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM
2
Cleared 510(K)
K
02
0697
DEPILASE TWIN YAG LASER SYSTEM
2
Cleared 510(K)
K
02
0099
MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE
2
Cleared 510(K)
K
02
0072
ATHOS LASER
2
Cleared 510(K)
K
02
0071
VIRIDIS DERMA LASER
2
Cleared 510(K)
K
02
0973
EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO
2
Cleared 510(K)
K
01
4272
PERIOLASE ND:YAG DENTAL LASER SYSTEM
2
Cleared 510(K)
K
01
4253
DERMACHILLER 4
2
Cleared 510(K)
K
01
4236
CLINICON WAVEGUIDE PLATFORM WITH INTERCONNECT FOR LUXAR ACCESSORIES
2
Cleared 510(K)
K
01
3201
CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR
2
Cleared 510(K)
K
01
4057
DERMASTAR ER:YAG LASER SYSTEM
2
Cleared 510(K)
K
01
4035
COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS
2
Cleared 510(K)
K
02
0463
DEPILASE YAG LASE PLUS LASER SYSTEM
2
Cleared 510(K)
K
01
3941
PULSION FS LASER KERATOME
2
Cleared 510(K)
K
01
3216
DIODENT DENTAL LASER SYSTEM
2
Cleared 510(K)
K
01
3940
LASER SYSTEM YELLOWSTAR
2
Cleared 510(K)
K
02
0412
DEPILASE TWIN LASE LASER SYSTEM
2
Cleared 510(K)
K
01
3825
CANDELA SMOOTHBEAM LASER SYSTEM
2
Cleared 510(K)
K
01
4048
CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS
2
Cleared 510(K)
K
01
3748
CANDELA SCLERO LONG PULSE LASER (AKA VBEAM)
2
Cleared 510(K)
K
01
3864
MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60
2
Cleared 510(K)
K
02
0107
SMARTEPIL
2
Cleared 510(K)
K
01
2398
DIOMED 15 DIODE LASER
2
Cleared 510(K)
K
01
4234
MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER
2
Cleared 510(K)
K
01
3461
NLITE SYSTEM,MODEL A00-1025
2
Cleared 510(K)
K
01
4130
NLITE SYSTEM
2
Cleared 510(K)
K
01
4100
OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND
2
Cleared 510(K)
K
01
3365
PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS
2
Cleared 510(K)
K
01
3366
PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR
2
Cleared 510(K)
K
01
1939
FOTONA DUALIS, FOTONA DUALIS PLUS
2
Cleared 510(K)
K
01
3193
MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE
2
Cleared 510(K)
K
01
1960
LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S4)
2
Cleared 510(K)
K
01
3901
MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM)
2
Cleared 510(K)
K
01
3493
INDIGO OPTIMA LASER SYSTEM
2
Cleared 510(K)
K
01
3028
PALOMAR SLP 1000
2
Cleared 510(K)
K
01
3047
FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM
2
Cleared 510(K)
K
01
2071
ENT LASERVISION
2
Cleared 510(K)
K
01
0771
PERIOLASE ND:YAG DENTAL LASER SYSTEM
2
Cleared 510(K)
K
01
2806
CYNOSURE PHOTOGENICA VL
2
Cleared 510(K)
K
01
1322
DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE
2
Cleared 510(K)
K
01
3499
DIOMED 15 PLUS AND DIOMED 30PLUS LASERS
2
Cleared 510(K)
K
01
2790
CYNOSURE PHOTOGENICA ER
2
Cleared 510(K)
K
01
3402
VISULAS 532S
2
Cleared 510(K)
K
01
2682
REPROCESSED LASER PROBE
2
Cleared 510(K)
K
01
1174
PARADIGM-FONTONA PEROVSKITE ND: YAP LASER SYSTEM AND ACCESSORIES
2
Cleared 510(K)
K
01
1070
DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR
2
Cleared 510(K)
K
01
2552
SCITON IMAGE HAIR REMOVAL LASER
2
Cleared 510(K)
K
01
2545
ARAMIS DERMATLOGIC LASER
2
Cleared 510(K)
K
01
1175
W.O.M. LASER U100
2
Cleared 510(K)
K
01
3043
CANDELA CLEARBEAM PULSED DYE LASER
2
Cleared 510(K)
K
01
1021
LASER 20
2
Cleared 510(K)
K
01
2127
PULSEMASTER ERBIUM DENTAL LASER SYSTEM
2
Cleared 510(K)
K
01
0804
MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS
2
Cleared 510(K)
K
01
0715
AL-40
2
Cleared 510(K)
K
01
2982
COOLTOUCH VARIZOOM
2
Cleared 510(K)
K
01
0618
PALOMAR DERMALUX PULSED LIGHT SYSTEM
2
Cleared 510(K)
K
01
1828
CYNOSURE ACCLAIM DERMATOLOGY LASER
2
Cleared 510(K)
K
01
1769
OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND
2
Cleared 510(K)
K
01
1747
PALOMAR LC 100 DIODE LASER
2
Cleared 510(K)
K
01
1703
LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES
2
Cleared 510(K)
K
00
2890
INTRALASE 600C LASER KERATOME
2
Cleared 510(K)
K
01
1423
INPULSE DENTAL LASER
2
Cleared 510(K)
K
01
1382
XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000
2
Cleared 510(K)
K
01
1207
LASER PERIPHERALS REUSABLE HOLMIUM FIBER
2
Cleared 510(K)
K
01
1092
CANDELA SPTL-1E PULSED DYE LASER
2
Cleared 510(K)
K
01
1041
WATERLASE, MILLENNIUM
2
Cleared 510(K)
K
01
1677
MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER
2
Cleared 510(K)
K
01
0927
MODIFICATION TO PROLITE PULSED LIGHT SYSTEM
2
Cleared 510(K)
K
01
0928
PROLITE VL PULSED LIGHT SYSTEM
2
Cleared 510(K)
K
01
1409
SLT LASERPRO CTH HOLMIUM LASER SYSTEM
2
Cleared 510(K)
K
01
0885
UNI-LASER 470
2
Cleared 510(K)
K
01
0580
PALOMAR SLP 1000
2
Cleared 510(K)
K
00
3318
PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X
2
Cleared 510(K)
K
01
0834
LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES
2
Cleared 510(K)
K
01
0689
MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM
2
Cleared 510(K)
K
01
0316
COOLTOUCH VARIA ND:YAG LASER SYSTEM; COOLTOUCH VARIA-II ND:YAG LASER SYSTEM
2
Cleared 510(K)
K
01
0284
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
2
Cleared 510(K)
K
00
3440
SOFTLASE - SURGICAL DIODE LASER SYSTEM
2
Cleared 510(K)
K
01
0113
LASER MECHANISMS LASER SCANNING SYSTEM
2
Cleared 510(K)
K
01
0104
CANDELA LONG PULSE ND:YAG
2
Cleared 510(K)
K
01
0046
NUVOLASE 532 MEDICAL LASER SYSTEM
2
Cleared 510(K)
K
01
0005
CYNOSURE PHOTOGENICA DL
2
Cleared 510(K)
K
00
4039
CYNOSURE PHOTOGENICA NEO-V
2
Cleared 510(K)
K
00
4021
F1 DIODE LASER SYSTEM
2
Cleared 510(K)
K
00
3993
DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE)
2
Cleared 510(K)
K
00
4006
SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER
2
Cleared 510(K)
K
00
4014
MD 30 COMPACT
2
Cleared 510(K)
K
00
3953
INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF001
2
Cleared 510(K)
K
00
3952
INDIGO LASEROPTIC TREATMENT SYSTEM
2
Cleared 510(K)
K
00
3955
LASEREX INTEGRE, MODEL LP2532
2
Cleared 510(K)
K
00
3614
LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM
2
Cleared 510(K)
K
01
0041
SLT DIFFUSER FIBER
2
Cleared 510(K)
K
00
3765
LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
2
Cleared 510(K)
K
01
0285
CONTOUR PROFILE LASER
2
Cleared 510(K)
K
00
3886
PALOMAR SPALIGHT PULSED LIGHT SYSTEM
2
Cleared 510(K)
K
00
3705
XTRAC EXCIMER LASER SYSTEM, MODEL AL7000
2
Cleared 510(K)
K
00
3715
COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH II
2
Cleared 510(K)
K
00
3885
VISULAS YAG II
2
Cleared 510(K)
K
00
3541
DENLASER, MODEL 800
2
Cleared 510(K)
K
00
3460
PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM
2
Cleared 510(K)
K
00
3385
TWILITE, TWILITE WHITE
2
Cleared 510(K)
K
00
3202
FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II
2
Cleared 510(K)
K
00
3151
MICROPOBE SERIES OF LASERS AND ACCESSORIES
2
Cleared 510(K)
K
00
3781
COOLTOUCH VARIA-II ND:YAG LASER SYSTEM
2
Cleared 510(K)
K
00
2308
OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A
2
Cleared 510(K)
K
00
3147
LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION)
2
Cleared 510(K)
K
00
2899
OPUS 20, MODEL 1ST
2
Cleared 510(K)
K
00
2884
PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES
2
Cleared 510(K)
K
00
2853
SCITON IMAGE HAIR REMOVAL LASER
2
Cleared 510(K)
K
00
1211
MODIFICATION TO INTRALASE 600C LASER KERATOME
2
Cleared 510(K)
K
00
3046
IMAGE VASCULAR LASER
2
Cleared 510(K)
K
00
2649
ARAMIS DERMATOLOGICAL LASER
2
Cleared 510(K)
K
00
0023
FRIENDLY LIGHT ER:YAG PULSED LASER
2
Cleared 510(K)
K
00
2421
CANDELA MID IR DIODE LASER SYSTEM
2
Cleared 510(K)
K
00
1676
OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A
2
Cleared 510(K)
K
00
0317
SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM
2
Cleared 510(K)
K
00
1990
DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES
2
Cleared 510(K)
K
00
0929
PROLITE PULSED LIGHT SYSTEM
2
Cleared 510(K)
K
00
2228
PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X
2
Cleared 510(K)
K
00
2296
CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15
2
Cleared 510(K)
K
00
1093
CANDELA SPTL-1B PULSED DYE LASER
2
Cleared 510(K)
K
00
0727
BUFFLIGHT CLT SURGICAL LASER SYSTEM
2
Cleared 510(K)
K
00
2072
PROLITE VL PULSED LIGHT SYSTEM
2
Cleared 510(K)
K
00
2032
C02 LASER MULTIPULSE
2
Cleared 510(K)
K
00
1784
VIRIDIS LASER
2
Cleared 510(K)
K
00
1704
ATHOS
2
Cleared 510(K)
K
00
0811
NLITE SYSTEM, SLS MODEL NUMBER A00-1025
2
Cleared 510(K)
K
00
0158
VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9
2
Cleared 510(K)
K
00
1589
CANDELA DYNAMIC COOLING DEVICE
2
Cleared 510(K)
K
00
2347
COOLTOUCH II
2
Cleared 510(K)
K
00
1975
CERALAS D10 810NM LASER, MODEL CERALAS D10-60
2
Cleared 510(K)
K
00
1527
FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES
2
Cleared 510(K)
K
99
0119
EPI-STAR SURGICAL LASER SYSTER
2
Cleared 510(K)
K
00
1746
LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (FAMILY OF PRODUCTS)
2
Cleared 510(K)
K
00
1511
O-LAS OPHTHALMIC PHOTODISRUPTOR
2
Cleared 510(K)
K
99
3328
SURGILIGHT, INC EXCIMER LASER
2
Cleared 510(K)
K
00
1322
PERFORMER 30 HPS
2
Cleared 510(K)
K
00
1031
URANUS, COMFORTOUCH LASER SYSTEM
2
Cleared 510(K)
K
99
3154
LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM
2
Cleared 510(K)
K
99
2757
CYNOSURE APOGEE-TKS DERMATOLOGICAL LASER
2
Cleared 510(K)
K
00
0990
OPUS 10 DENTAL DIODE LASER
2
Cleared 510(K)
K
00
0072
DORNIER MEDILAS D SKINPULSE
2
Cleared 510(K)
K
99
4116
LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM)
2
Cleared 510(K)
K
99
4260
CANDELA GENTLELASE GL DERMATOLOGICAL LASER
2
Cleared 510(K)
K
00
1243
DORNIER MEDILAS H
2
Cleared 510(K)
K
99
4225
PALOMAR SLP 2000
2
Cleared 510(K)
K
00
0693
UMECO OPTIMA MULTILINE LASER SYSTEM
2
Cleared 510(K)
K
00
0503
MEDART 520 COOLING SYSTEM
2
Cleared 510(K)
K
99
3815
UNI-LASER 430
2
Cleared 510(K)
K
00
1263
SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 2040
2
Cleared 510(K)
K
00
0805
KAVO K.E.Y. LASER 1242
2
Cleared 510(K)
K
00
0982
A100 AESTHETIC DIODE LASER
2
Cleared 510(K)
K
99
2597
LORAD LT-100 LASER TREATMENT SYSTEM
2
Cleared 510(K)
K
00
0222
UM-L25
2
Cleared 510(K)
K
00
0106
DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES
2
Cleared 510(K)
K
00
0192
E3 MICROPROB SERIES OF LASERS AND ACCESSORIES
2
Cleared 510(K)
K
00
0498
COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER
2
Cleared 510(K)
K
00
0490
CYNOSURE PHOTOGENICA VLS-STAR
2
Cleared 510(K)
K
99
0718
ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)
2
Cleared 510(K)
K
99
1798
ACME MEDICAL AESTHETIC ND:YAG LASER
2
Cleared 510(K)
K
99
4014
ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT
2
Cleared 510(K)
K
99
3834
SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C
2
Cleared 510(K)
K
99
3911
CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50
2
Cleared 510(K)
K
99
3828
CERALAS D10 810NM DIODE LASER
2
Cleared 510(K)
K
99
2914
EXCIMER LASER PHOTOTHERAPY SYSTEM, AL7000
2
Cleared 510(K)
K
99
1935
EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM
2
Cleared 510(K)
K
99
3671
CANDELA SCLERO LONG PULSE DYE LASER
2
Cleared 510(K)
K
99
4273
MODEL 1000 HOLMIUM LASER SYSTEM
2
Cleared 510(K)
K
99
4437
CYNOSURE PHOTOGENICA SPIR