Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- EMFKnife, Surgical1Product Code
- EPTMicroscope, Surgical1Product Code
- EPWSupport, Head, Surgical, Ent1Product Code
- OEJTransurethral Electrosurgical Unit, Benign Prostatic Hyperplasia2Product Code
- FAZSystem, Cryosurgical, Liquid Nitrogen, For Urology2Product Code
- OEKWater-Induced Thermotherapy System, Benign Prostatic Hyperplasia2Product Code
- GAGStapler, Surgical2Product Code
- DWGElectrosurgical Device2Product Code
- DWHBlade, Saw, Surgical, Cardiovascular1Product Code
- DWISaw, Electrically Powered1Product Code
- DWONeedle, Biopsy, Cardiovascular1Product Code
- QQSStapler, Skin1Product Code
- BTAPump, Portable, Aspiration (Manual Or Powered)2Product Code
- BWAUnit, Electrosurgical And Coagulation, With Accessories2Product Code
- BWNTable And Attachments, Operating-Room1Product Code
- BWPShoe And Shoe Cover, Conductive1Product Code
- FGYCannula, Injection1Product Code
- FHMApparatus, Suturing, Stomach And Intestinal1Product Code
- FHRNeedle, Gastro-Urology1Product Code
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature2Product Code
- FNWPad, Kelly2Product Code
- FQOTable, Operating-Room, Ac-Powered1Product Code
- FQPLamp, Operating-Room2Product Code
- FSETable, Operating-Room, Manual1Product Code
- FSHTray, Surgical, Needle1Product Code
- FSMTray, Surgical, Instrument1Product Code
- FSOMicroscope, Surgical, General & Plastic Surgery1Product Code
- FSPLoupe, Diagnostic/Surgical1Product Code
- FSQLight, Surgical, Instrument2Product Code
- FSSLight, Surgical, Floor Standing2Product Code
- FSTLight, Surgical, Fiberoptic2Product Code
- FSWLight, Surgical, Endoscopic2Product Code
- FSXLight, Surgical, Connector2Product Code
- FSYLight, Surgical, Ceiling Mounted2Product Code
- FSZLight, Surgical, Carrier2Product Code
- FTALight, Surgical, Accessories2Product Code
- FTCLight, Ultraviolet, Dermatological2Product Code
- FTDLamp, Surgical2Product Code
- FTFIlluminator, Non-Remote2Product Code
- FTGIlluminator, Remote2Product Code
- FTHCamera, Still, Microsurgical1Product Code
- FTSCamera, Cine, Endoscopic, With Audio1Product Code
- FTTCamera, Still, Surgical1Product Code
- FTXMirror, General & Plastic Surgery1Product Code
- FTYTape, Measuring, Rulers And Calipers1Product Code
- FWBCamera, Television, Surgical, Without Audio1Product Code
- FWCCamera, Television, Surgical, With Audio1Product Code
- FWDCamera, Television, Microsurgical, Without Audio1Product Code
- FWECamera, Television, Microsurgical, With Audio1Product Code
- FWFCamera, Television, Endoscopic, Without Audio1Product Code
- FWGCamera, Television, Endoscopic, With Audio1Product Code
- FWHCamera, Cine, Surgical, Without Audio1Product Code
- FWICamera, Cine, Surgical, With Audio1Product Code
- FWJCamera, Cine, Microsurgical, Without Audio1Product Code
- FWKCamera, Cine, Microsurgical, With Audio1Product Code
- FWLCamera, Cine, Endoscopic, Without Audio1Product Code
- FWWTable, Operating-Room, Pneumatic1Product Code
- FWXTable, Operating-Room, Mechanical1Product Code
- FWYTable, Operating-Room, Non-Electrical1Product Code
- FWZOperating Room Accessories Table Tray1Product Code
- FXMCamera, Still, Endoscopic1Product Code
- FXNTape, Camera, Surgical1Product Code
- FXQLens, Camera, Surgical1Product Code
- FXRHolder, Camera, Surgical1Product Code
- FXSFrame, Camera, Surgical1Product Code
- FXTFilm, Camera, Surgical1Product Code
- FXWShoes, Operating-Room1Product Code
- FYEDress, Surgical1Product Code
- FYFCap, Surgical1Product Code
- FZKChair, Surgical, Non-Electrical1Product Code
- FZMStool, Operating-Room1Product Code
- FZOChisel, Surgical, Manual1Product Code
- FZPClip, Implantable2Product Code
- FZQClip, Removable (Skin)1Product Code
- FZRContractor, Surgical1Product Code
- FZSCurette, Surgical, General Use1Product Code
- FZTCutter, Surgical1Product Code
- FZWExpander, Surgical, Skin Graft1Product Code
- FZXGuide, Surgical, Instrument1Product Code
- FZYHammer, Surgical1Product Code
- FZZMarker, Skin1Product Code
- GAANeedle, Aspiration And Injection, Disposable1Product Code
- GABNeedle, Suturing, Disposable1Product Code
- GACRasp, Surgical, General & Plastic Surgery1Product Code
- GADRetractor1Product Code
- GAESnare, Surgical1Product Code
- GAFSpatula, Surgical, General & Plastic Surgery1Product Code
- GAHStylet, Surgical, General & Plastic Surgery1Product Code
- GAIStripper, Vein, Reusable1Product Code
- GAJStripper, Vein, Disposable1Product Code
- GAKSuture, Absorbable2Product Code
- GALSuture, Absorbable, Natural2Product Code
- GAMSuture, Absorbable, Synthetic, Polyglycolic Acid2Product Code
- GANSuture, Absorbable, Synthetic2Product Code
- GAOSuture, Nonabsorbable2Product Code
- GAPSuture, Nonabsorbable, Silk2Product Code
- GAQSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile2Product Code
- GARSuture, Nonabsorbable, Synthetic, Polyamide2Product Code
- GASSuture, Nonabsorbable, Synthetic, Polyester2Product Code
- GATSuture, Nonabsorbable, Synthetic, Polyethylene2Product Code
- GAWSuture, Nonabsorbable, Synthetic, Polypropylene2Product Code
- GBACatheter, Balloon Type1Product Code
- GBBChair, Surgical, Ac-Powered1Product Code
- GBCLamp, Surgical, Incandescent2Product Code
- GBNCatheter, Pediatric, General & Plastic Surgery1Product Code
- GBOCatheter, Nephrostomy, General & Plastic Surgery1Product Code
- GBPCatheter, Multiple Lumen1Product Code
- GBQCatheter, Continuous Irrigation1Product Code
- GBSCatheter, Ventricular, General & Plastic Surgery1Product Code
- GBWCatheter, Peritoneal1Product Code
- GBXCatheter, Irrigation1Product Code
- GBYCatheter, Eustachian, General & Plastic Surgery1Product Code
- GBZCatheter, Cholangiography1Product Code
- GCBNeedle, Catheter1Product Code
- GCCDilator, Catheter1Product Code
- GCDConnector, Catheter1Product Code
- GCEAdaptor, Catheter1Product Code
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered1Product Code
- GCZRetainer, Surgical1Product Code
- GDCTable, Operating-Room, Electrical1Product Code
- GDFGuide, Needle, Surgical1Product Code
- GDGHook, Surgical, General & Plastic Surgery1Product Code
- GDHGouge, Surgical, General & Plastic Surgery1Product Code
- GDIDissector, Surgical, General & Plastic Surgery1Product Code
- GDJClamp, Surgical, General & Plastic Surgery1Product Code
- GDLNeedle, Suturing, Reusable1Product Code
- GDMNeedle, Aspiration And Injection, Reusable1Product Code
- GDNKnife, Amputation1Product Code
- GDOApplier, Surgical, Clip1Product Code
- GDRSaw, Manual And Accessories1Product Code
- GDTStaple, Removable (Skin)1Product Code
- GDWStaple, Implantable2Product Code
- GDXScalpel, One-Piece1Product Code
- GDYGauze/Sponge, Internal, X-Ray Detectable1Product Code
- GDZHandle, Scalpel1Product Code
- GEACannula, Surgical, General & Plastic Surgery1Product Code
- GECBrush, Scrub, Operating-Room1Product Code
- GEDBrush, Dermabrasion, Manual1Product Code
- GEEBrush, Biopsy, General & Plastic Surgery1Product Code
- GEFApplier, Staple, Surgical,1Product Code
- GEGElevator, Surgical, General & Plastic Surgery1Product Code
- GEHUnit, Cryosurgical, Accessories2Product Code
- GEIElectrosurgical, Cutting & Coagulation & Accessories2Product Code
- GEJCarrier, Ligature1Product Code
- GENForceps, General & Plastic Surgery1Product Code
- GEOFile, Surgical, General & Plastic Surgery1Product Code
- GESBlade, Scalpel1Product Code
- GETMotor, Surgical Instrument, Pneumatic Powered1Product Code
- GEXPowered Laser Surgical Instrument2Product Code
- K252564Medical Diode Laser Systems (VeinCure)2Cleared 510(K)
- K252519CO2 Laser Therapy System (K106)2Cleared 510(K)
- K252515Q-Switched Nd:Yag laser (K690)2Cleared 510(K)
- K251303Tamburo Thulium Fiber Laser System2Cleared 510(K)
- K252427Diode Laser Hair Removal Machine (GLD01)2Cleared 510(K)
- K252529Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0068130120)2Cleared 510(K)
- K251824Patriot Duo2Cleared 510(K)
- K253100MultiPulse TFL2Cleared 510(K)
- K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)2Cleared 510(K)
- K252345Picosecond Laser Device (PF131-BI)2Cleared 510(K)
- K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)2Cleared 510(K)
- K250776Lithoblast Single Use Holmium Laser Fibers2Cleared 510(K)
- K251699The Botticelli (Model: Athena)2Cleared 510(K)
- K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)2Cleared 510(K)
- K242946HESTIA (L200-A)2Cleared 510(K)
- K252447Picosecond laser device (BMPS4)2Cleared 510(K)
- K251919Thulium Laser System (Deluxlase)2Cleared 510(K)
- K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN)2Cleared 510(K)
- K250071Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories2Cleared 510(K)
- K251100IPGTFL-022Cleared 510(K)
- K242859VEGA2Cleared 510(K)
- K251457Diode laser therapy device (VADER)2Cleared 510(K)
- K251727GLAM LED Facial Mask (TB-2386F)2Cleared 510(K)
- K250261Heager Medical Laser Family (Sabrina/Adolf)2Cleared 510(K)
- K251801Diode laser device (BM091)2Cleared 510(K)
- K251432Olo2Cleared 510(K)
- K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)2Cleared 510(K)
- K251339Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)2Cleared 510(K)
- K250504Leonardo Duster2Cleared 510(K)
- K251149AviClear Laser System2Cleared 510(K)
- K251759Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers2Cleared 510(K)
- K250165Pastelle2Cleared 510(K)
- K251049SurgiLight 1470 Diode Laser System (Model:Halo)2Cleared 510(K)
- K243701AuroLase® System2Cleared 510(K)
- K251329Diode laser device (RF3120-BI)2Cleared 510(K)
- K251632Optimas MAX System2Cleared 510(K)
- K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)2Cleared 510(K)
- K250782Fractional CO2 Laser Machine2Cleared 510(K)
- K243683Deka Bluebeam2Cleared 510(K)
- K250465CO2 Laser Machine (Lume)2Cleared 510(K)
- K250722Nd: YAG Laser Therapy System (QN-1)2Cleared 510(K)
- K240983Discovery Pico; Discovery Pico Plus; Discovery Pico Derm2Cleared 510(K)
- K250195MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)2Cleared 510(K)
- K251230The Alma Hybrid Laser System2Cleared 510(K)
- K251288Veincare2Cleared 510(K)
- K250041Medical Picosecond ND: YAG Laser System (PZ-6)2Cleared 510(K)
- K250431Medical Diode Laser Hair Removal System (MNLT-D1)2Cleared 510(K)
- K251094Alma Veil2Cleared 510(K)
- K242951Diode laser hair removal machine (QDTM-02)2Cleared 510(K)
- K250206Diode laser system (Night Universe; Predator)2Cleared 510(K)
- K250183CO2 Laser System (CO2 Laser SST-L23)2Cleared 510(K)
- K250809Stellar M222Cleared 510(K)
- K243044Alma Harmony2Cleared 510(K)
- K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)2Cleared 510(K)
- K250189AdvaTx2Cleared 510(K)
- K250018Medical Diode Laser Systems (THEIA808)2Cleared 510(K)
- K243630Medical Laser System Incanto / Evoline Platinum /Evoline2Cleared 510(K)
- K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)2Cleared 510(K)
- K250113neoLaser Laser Surgery Fibers2Cleared 510(K)
- K243993Photon Therapy Apparatus (BL-10)2Cleared 510(K)
- K243957PICOALEX2Cleared 510(K)
- K242207NOABLE LASER2Cleared 510(K)
- K242943Q Switched Nd:YAG Laser machine (QNHF-01)2Cleared 510(K)
- K234004Medical diode laser systems (CHARISMA, REGAL)2Cleared 510(K)
- K243588Single Use CO2 Laser Fiber (HAF005001)2Cleared 510(K)
- K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)2Cleared 510(K)
- K241527Pastelle Pro2Cleared 510(K)
- K243780HELIOS 785 Pico (1754V2)2Cleared 510(K)
- K243465Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate)2Cleared 510(K)
- K241270BTL-7542Cleared 510(K)
- K242941CO2 Laser Therapy Systems (SHE-LSP003-1)2Cleared 510(K)
- K243445Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)2Cleared 510(K)
- K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM)2Cleared 510(K)
- K243037Diode Laser System model Dawn-S2Cleared 510(K)
- K243121SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA; TCRH 7-SMA; FEF 2.2-SMA; CFE 0.6-SMA; SSRH 8Z-SMA; SSRH 4-SMA; SSRH 6-SMA; SSRH 9-SMA; SSRH 10-SMA; SSRH 11-SMA; SSRH 7L-SMA; TCRH 7Z-SMA; FEF 1.8-SMA; CFE 0.55-SMA; CFE 0.36-SMA; LAL 550-SMA; LAL 550Z-SMA; LAL 365-SMA; LAL 365Z-SMA; ER2; ERP2; GR2; GRP2; ER4; ERP4; GR4; GRP4; ER6; ERP6; GR6; GRP6; ER8; ERP8; GR8; GRP8; ER10; ERP10; GR10; GRP10; ER12; ERP12; GR12; GRP12; MD2.5; MD3.5; HP1.0; MTP1.5; MTP3.5; MTRG1.5;2Cleared 510(K)
- K243147LGO-Surgical Laser Fibers2Cleared 510(K)
- K242534HandPICO Fractional Laser Handpiece Tip2Cleared 510(K)
- K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)2Cleared 510(K)
- K242987Thulium Fiber Laser (FiberLAZE+, FiberLAZE)2Cleared 510(K)
- K242293Medical Thulium Fiber Laser Systems (UroFiber 60Q)2Cleared 510(K)
- K241498Diode laser Treatment System (K18)2Cleared 510(K)
- K241930Veincare2Cleared 510(K)
- K241646ORTIV (ORTIV-BL, ORTIV-WH)2Cleared 510(K)
- K240543Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia)2Cleared 510(K)
- K242183Fractional CO2 Laser Therapy System (EXFU CO2)2Cleared 510(K)
- K242132FREDDO2Cleared 510(K)
- K242035Accure Laser System2Cleared 510(K)
- K241951Lasya-Trinity2Cleared 510(K)
- K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT2Cleared 510(K)
- K231948MEDIYAG2Cleared 510(K)
- K242206ACTIVO2Cleared 510(K)
- K241860Diode Laser Hair Removal System2Cleared 510(K)
- K240604MTONE EVO (MTONE EVO)2Cleared 510(K)
- K241771Liftendo; Liftendo 2.02Cleared 510(K)
- K242349FoLix2Cleared 510(K)
- K241672COPRO 32Cleared 510(K)
- K242251Litho 60; Litho 100; Litho 1502Cleared 510(K)
- K242202LightWalker Laser System Family2Cleared 510(K)
- K242191SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)2Cleared 510(K)
- K242142Fraxel® FTX Laser System2Cleared 510(K)
- K241699SUPER VELOCE2Cleared 510(K)
- K241547Diode Laser Therapy Device (DF-DIODE LASER-S1)2Cleared 510(K)
- K241656Eneka Selectif2Cleared 510(K)
- K231950MEDIDIODE2Cleared 510(K)
- K241642Diode Laser Hair Removal System (MBT-Diode Laser)2Cleared 510(K)
- K241293LED Light Therapy Device, ELIXIR MD™2Cleared 510(K)
- K241600Dermablate2Cleared 510(K)
- K241406Lavieen2Cleared 510(K)
- K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)2Cleared 510(K)
- K241459MOTUS PRO Family2Cleared 510(K)
- K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)2Cleared 510(K)
- K240747Medical Diode Laser (M2-GK)2Cleared 510(K)
- K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)2Cleared 510(K)
- K241358BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E2Cleared 510(K)
- K233007Picosecond Nd:YAG Laser System; PICO LEGEND2Cleared 510(K)
- K240644Medical Diode Laser (S1Pro)2Cleared 510(K)
- K240222Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)2Cleared 510(K)
- K240159InnoVoyce VYLO2Cleared 510(K)
- K240874Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)2Cleared 510(K)
- K233344Regenalase Laser System2Cleared 510(K)
- K240520Diode Laser Hair Removal System (SH-VD910)2Cleared 510(K)
- K240474Multi-function Platform Systems (BL-M10)2Cleared 510(K)
- K240752DEKA TORO2Cleared 510(K)
- K240386Picosecond Nd:YAG Laser Systems (BL-C10)2Cleared 510(K)
- K233803UltraClear Laser System (N/A)2Cleared 510(K)
- K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDD2Cleared 510(K)
- K232858ORskin Blue2Cleared 510(K)
- K240118Picosecond Nd:YAG Laser System2Cleared 510(K)
- K240816MeDioStar2Cleared 510(K)
- K232133Co2 Laser System, Models: PureLase And VanLase2Cleared 510(K)
- K233757TitanPico Laser Workstation (PICO-450)2Cleared 510(K)
- K234057NIRVANA2Cleared 510(K)
- K234085LUNE™ PureHygiene2Cleared 510(K)
- K240179Medical Diode Laser (Model: L2)2Cleared 510(K)
- K232568IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories2Cleared 510(K)
- K240537SMARTXIDE PRO2Cleared 510(K)
- K234104PICOANDY (Q-Switched Nd:YAG Laser)2Cleared 510(K)
- K240497Smartxide Tetra Pro2Cleared 510(K)
- K240132EmoLED (v. 2-USA)2Cleared 510(K)
- K240396Elite iQ PRO (M122K1)2Cleared 510(K)
- K231876MultiPulse HoPLUS2Cleared 510(K)
- K231896Diode Laser Therapy System2Cleared 510(K)
- K231514Azure2Cleared 510(K)
- K233024Alma Harmony2Cleared 510(K)
- K233416Cryojet Plus (SHE-ACP001-1)2Cleared 510(K)
- K233756Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)2Cleared 510(K)
- K233143PiXel8-Reveal2Cleared 510(K)
- K233804Resonic Rapid Acoustic Pulse Device2Cleared 510(K)
- K231910DermRays Revive2Cleared 510(K)
- K233224Epilaser Pro2Cleared 510(K)
- K233077FlashHeal 2 (FlashHeal 2.0)2Cleared 510(K)
- K232106Air Gap Fiber2Cleared 510(K)
- K221766Solon2Cleared 510(K)
- K233304Omnimax S3, Omnimax S42Cleared 510(K)
- K233018PICOSECOND Nd:YAG Laser System2Cleared 510(K)
- K233237xeo+ Family2Cleared 510(K)
- K231061NeuroBlate System2Cleared 510(K)
- K232769BeaMed Laser Surgery Fibers2Cleared 510(K)
- K233301ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories2Cleared 510(K)
- K232716Q-Switched Nd:Yag laser2Cleared 510(K)
- K232709Diode laser therapy device2Cleared 510(K)
- K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)2Cleared 510(K)
- K232532Nd:Yag Laser Therapy Systems2Cleared 510(K)
- K233090DEKA AGAIN PRO family2Cleared 510(K)
- K232236Echo2Cleared 510(K)
- K231901Hakon, Hakon Smart2Cleared 510(K)
- K231894LED Spectrum therapy instrument2Cleared 510(K)
- K231791PENTO Nd:YAG and Alexandrite laser system2Cleared 510(K)
- K230535KARL STORZ Urological Laser Accessories2Cleared 510(K)
- K223727Lavieen2Cleared 510(K)
- K231718Holmium Medical Laser2Cleared 510(K)
- K230342Phototherapy System (OL-PDT950)2Cleared 510(K)
- K231054V-Laser2Cleared 510(K)
- K230268ZenPro 402Cleared 510(K)
- K231548Medical Diode Laser, Model S1Pro2Cleared 510(K)
- K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC2Cleared 510(K)
- K231945VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits2Cleared 510(K)
- K230077LaserME2Cleared 510(K)
- K230660AviClear Laser System2Cleared 510(K)
- K212733Diode laser therapy device2Cleared 510(K)
- K212734Diode laser therapy device2Cleared 510(K)
- K231309SCAR 32Cleared 510(K)
- K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)2Cleared 510(K)
- K230580Diode Laser System2Cleared 510(K)
- K230460Laser Thermal Therapy Kit2Cleared 510(K)
- K230373HELIOS 785 Pico2Cleared 510(K)
- K230340Lucas Plus2Cleared 510(K)
- K222352Epildream HP 4000 MED2Cleared 510(K)
- K230819OmniGuide RFID Surgical Laser Fibers2Cleared 510(K)
- K230274Medical Diode Laser (M2)2Cleared 510(K)
- K223778Diode Laser Hair Removal System (RD-SLD600)2Cleared 510(K)
- K222485SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser2Cleared 510(K)
- K222983NeuroBlate Fusion-S Software V3.172Cleared 510(K)
- K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm2Cleared 510(K)
- K230308Alma Harmony2Cleared 510(K)
- K230371The Alma Soprano Titanium2Cleared 510(K)
- K213669LIGHTSCALPEL LS-40202Cleared 510(K)
- K223680Eneka Pro2Cleared 510(K)
- K222751LED Light Therapy Device, KN-7000L2Cleared 510(K)
- K221306SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories2Cleared 510(K)
- K223588PALLAS Premium2Cleared 510(K)
- K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V2Cleared 510(K)
- K223540AvalancheLase Family2Cleared 510(K)
- K223685SmoothCool HR System2Cleared 510(K)
- K222221DEKA HELIX2Cleared 510(K)
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- K222109Accure Laser2Cleared 510(K)
- K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS2Cleared 510(K)
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- K222369PURE Laser2Cleared 510(K)
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- K211605Dual Switch2Cleared 510(K)
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- K212790XLase Plus2Cleared 510(K)
- K221789IRIS Pi Q switched Nd YAG laser2Cleared 510(K)
- K213252Dornier Thulio2Cleared 510(K)
- K213761Joule diVa System2Cleared 510(K)
- K212073Alma Diode Tabletop Laser2Cleared 510(K)
- K221083Smartlux Mini2Cleared 510(K)
- K221571InMode Multi-system2Cleared 510(K)
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- K213726PL-1 Skin Treatment System2Cleared 510(K)
- K213250Secret Duo2Cleared 510(K)
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- K212663HELIOS IV 7852Cleared 510(K)
- K214049Leaseir MHR Xcell2Cleared 510(K)
- K213261EpilME2Cleared 510(K)
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- K213889PicoStar2Cleared 510(K)
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- K210634MCL 31 Dermablate System2Cleared 510(K)
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- K213557Finexel2Cleared 510(K)
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- K213554Sentient Manufacturing Laser Fiber2Cleared 510(K)
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- K211517Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories2Cleared 510(K)
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- K192600Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 602Cleared 510(K)
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- K192539Deka Luxea2Cleared 510(K)
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- K180597AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO2Cleared 510(K)
- K180426Empower H352Cleared 510(K)
- K180423Empower H652Cleared 510(K)
- K180406Ellipse Ydun2Cleared 510(K)
- K180224ELEMENT-TL2Cleared 510(K)
- K180044SIROLaser Blue2Cleared 510(K)
- K180350Dornier Medilas H Solvo 35 Laser2Cleared 510(K)
- K172818LMT-30002Cleared 510(K)
- K173677InMode VLaze2Cleared 510(K)
- K173067LightForce LTS Model 1000, 1500, 2500, and 40002Cleared 510(K)
- K180193DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)2Cleared 510(K)
- K180158Surgical Laser fibers2Cleared 510(K)
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- K173199PicoSure Workstation2Cleared 510(K)
- K173285JOULE SYSTEM2Cleared 510(K)
- K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules2Cleared 510(K)
- K1730022940 nm Er:Yag Laser Handpiece2Cleared 510(K)
- K172908Q-Switched Nd:YAG Laser System2Cleared 510(K)
- K173038CuRAS Nd:YAG Laser2Cleared 510(K)
- K172819LightWalker Laser System Family2Cleared 510(K)
- K172771Epic Pro 9402Cleared 510(K)
- K173169Rapid Family2Cleared 510(K)
- K173305NeuroBlate System2Cleared 510(K)
- K172363DEKA SMARTXIDE ULTRASPEED2Cleared 510(K)
- K172362DEKA SMARTXIDE TOUCH2Cleared 510(K)
- K172639PALLAS 308/311 Solid-State UV Laser System2Cleared 510(K)
- K172077Cutera enlighten III Laser System2Cleared 510(K)
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- K172881NeuroBlate System2Cleared 510(K)
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- K1721985852Cleared 510(K)
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- K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity2Cleared 510(K)
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- K171227StarWalker2Cleared 510(K)
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- K170738InMode Diolaze XL2Cleared 510(K)
- K171079Q-Switched Nd:YAG Laser System2Cleared 510(K)
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- K171945Discovery Pico, Discovery Pico Plus2Cleared 510(K)
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- K171711Thunder, Thunder VT, Thunder HR2Cleared 510(K)
- K171009LASEMD Laser System2Cleared 510(K)
- K163449HyPHo Laser System2Cleared 510(K)
- K162886DEKA MOTUS AX2Cleared 510(K)
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- K170366Laser Peripherals, LLC Family of Bare Laser Fibers2Cleared 510(K)
- K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece2Cleared 510(K)
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- K163196ACTION II Laser System2Cleared 510(K)
- K170121Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories2Cleared 510(K)
- K160677MICRORUPTOR 62Cleared 510(K)
- K170500SIROLaser Advance+2Cleared 510(K)
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- K162334U.S. Laser Worx Patriot 1 family of lasers2Cleared 510(K)
- K170936Cutera enlighten III Laser System2Cleared 510(K)
- K170215LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock2Cleared 510(K)
- K170724NeuroBlate System2Cleared 510(K)
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- K162837Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser System2Cleared 510(K)
- K161926ND YAG Q-switch Laser Therapy Machine2Cleared 510(K)
- K163123Q-Switched Nd:YAG Laser Therapy Systems2Cleared 510(K)
- K162454PicoWay Laser System2Cleared 510(K)
- K162851eLyx-PRO2Cleared 510(K)
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- K162765Venus Velocity Diode Laser System2Cleared 510(K)
- K162114Photon, Photon Plus2Cleared 510(K)
- K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)2Cleared 510(K)
- K163222Discovery Pico Family2Cleared 510(K)
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- K162191NAVILAS Laser System2Cleared 510(K)
- K162363V30 system, V-Form Handpiece BC Medium applicator2Cleared 510(K)
- K162914VenaCure EVLT NeverTouch Procedure Kit2Cleared 510(K)
- K161692Diode Laser Therapy Machine2Cleared 510(K)
- K162781Magma Spark2Cleared 510(K)
- K161670Lucid Q-PTP / HWA 552Cleared 510(K)
- K160488Cutera enlighten III Laser System2Cleared 510(K)
- K160312FRAXIS DUO2Cleared 510(K)
- K162169EdgeOne CO2 Laser2Cleared 510(K)
- K162762NeuroBlate System2Cleared 510(K)
- K161981Olive Plus2Cleared 510(K)
- K161925CO2 Laser Therapy Machine2Cleared 510(K)
- K162416IRIDEX Cyclo G6 Laser System, G-Probe Illuminate2Cleared 510(K)
- K161185LUCERNA Dental Laser2Cleared 510(K)
- K160413Sterling 5W Diode Laser2Cleared 510(K)
- K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra2Cleared 510(K)
- K161356Matrix LS-40 CO2 Laser System2Cleared 510(K)
- K161503ORION2Cleared 510(K)
- K161403A.R.C. Laser Surgical Fibers and Probes2Cleared 510(K)
- K161771Medilas H Laser Fibers2Cleared 510(K)
- K161669Waterlase Express2Cleared 510(K)
- K153124DuraLazeTM HoLEP Laser Fiber2Cleared 510(K)
- K160607PicoWay Laser System2Cleared 510(K)
- K152737Lite Touch2Cleared 510(K)
- K152667ATOVEN-Reusable Laser Fiber2Cleared 510(K)
- K160012O-pel Laser and families of probe delivery devices2Cleared 510(K)
- K152856Helios III2Cleared 510(K)
- K160480PicoSure Workstation2Cleared 510(K)
- K160952Alma Diode Tabletop Laser2Cleared 510(K)
- K160227ACCENTO / HWA Dual/Single laser2Cleared 510(K)
- K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber2Cleared 510(K)
- K153229Superbium2Cleared 510(K)
- K153566Magma System2Cleared 510(K)
- K160368EVO platform2Cleared 510(K)
- K153564PURE CRYOGEN2Cleared 510(K)
- K160513Quanta System Surgical Laser fibers2Cleared 510(K)
- K151763PerioLase Nd:YAG Pulsed Dental Laser System2Cleared 510(K)
- K153671Family of CoolGlide Aesthetic Lasers2Cleared 510(K)
- K153527PicoWay Laser System2Cleared 510(K)
- K160392Novilase Laser Therapy System, Model LTS-22Cleared 510(K)
- K152736SKIN CARE2Cleared 510(K)
- K152611V20 system2Cleared 510(K)
- K153718Spirit Hair Removal laser Family2Cleared 510(K)
- K151569Tranberg CLS Laser Fiber2Cleared 510(K)
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- K141555ADVANTAGE2Cleared 510(K)
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- K101817LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N2Cleared 510(K)
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- K060326LASERTX - DIODE LASER & DELIVERY SYSTEM2Cleared 510(K)
- K060310FRAXEL II SR LASER SYSTEM AND ACCESSORIES2Cleared 510(K)
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- K060459QUADROSTAR 9802Cleared 510(K)
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- K060216ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM2Cleared 510(K)
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- K052310CRYOFLOW 700, CRYOFLOW 10002Cleared 510(K)
- K053616POLARIS WR, ST APPLICATOR2Cleared 510(K)
- K053511DA VINCI FEMTOSECOND SURGICAL LASER2Cleared 510(K)
- K060338FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO2Cleared 510(K)
- K060069PALOMAR LUXIR FRACTIONAL HANDPIECE2Cleared 510(K)
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- K052991RADIANCY FACIAL SKINCARE DEVICE2Cleared 510(K)
- K052442RADIANCY SKINSTATION WITH PSORIASIS LIGHT UNIT ASSEMBLY2Cleared 510(K)
- K060050MEGABEAM SIDEFIBER FIBER OPTIC DELIVERY SYSTEM2Cleared 510(K)
- K052680CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES2Cleared 510(K)
- K053161SIROLASER2Cleared 510(K)
- K053324CHROMOLITE SYSTEM2Cleared 510(K)
- K051113QUANTA SYSTEM ETRNA GIOVINEZZA2Cleared 510(K)
- K052848SPECTRA HAIR REMOVAL LASER2Cleared 510(K)
- K053457VAPORMAX II2Cleared 510(K)
- K052604STARLITE 20062Cleared 510(K)
- K052688ELLIPSE FLEX PPT, MODEL 9ESF72552Cleared 510(K)
- K052874SOPRANO HAIR REMOVAL DIODE LASER2Cleared 510(K)
- K052526NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES2Cleared 510(K)
- K052806BURANE2Cleared 510(K)
- K052495ATRILAZE MALLEABLE ABLATION PROBE2Cleared 510(K)
- K052336SPECTRAQUATTRO PULSED LIGHT SYSTEM2Cleared 510(K)
- K051508MED FLASH II INTENSE PULSED LIGHT SYSTEM.2Cleared 510(K)
- K051259VERSACLEAR SKIN THERAPY SYSTEM, MODEL 1002Cleared 510(K)
- K052324POLARIS LV, LVA APPLICATOR2Cleared 510(K)
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- K051876MULTIWAVE XR2Cleared 510(K)
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- K052129LUMENIS 1000 INTEGRATED SLIT LAMP2Cleared 510(K)
- K051996DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 302Cleared 510(K)
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- K043032DEALIGHT IPL2Cleared 510(K)
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- K051268RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT2Cleared 510(K)
- K050841FRAXEL SR LASER SYSTEM2Cleared 510(K)
- K051255LUMIPHASE-R2Cleared 510(K)
- K051399WAVELIGHT AURIGA2Cleared 510(K)
- K050779CYNERGY MULTIPLEX LASER2Cleared 510(K)
- K042630REVLIGHT SKIN CARE SYSTEM2Cleared 510(K)
- K050696MEDLITE C1 Q-SWITCHED ND:YAG LASER2Cleared 510(K)
- K050673CANDELA FAMILY OF PULSE DYE LASER SYSTEMS2Cleared 510(K)
- K050738FT FIBER OPTIC DELIVERY SYSTEMS2Cleared 510(K)
- K051167REVOLIX AND REVOLIX JR2Cleared 510(K)
- K043377ZENO2Cleared 510(K)
- K050453ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-000502Cleared 510(K)
- K050900MEDIOSTAR XT2Cleared 510(K)
- K050672ERCHONIA EVRL LASER2Cleared 510(K)
- K050950MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS2Cleared 510(K)
- K050274DIODENT II DENTAL LASER SYSTEM2Cleared 510(K)
- K041554AIP INTENSE PULSED LIGHT SYSTEM2Cleared 510(K)
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- K050562OCULIGHT GL/GLX2Cleared 510(K)
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- K050679CUTERA SOLERA OPUS AESTHETIC PRODUCT2Cleared 510(K)
- K050047CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY2Cleared 510(K)
- K043521BIOSYAG 50 MED2Cleared 510(K)
- K050293FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS2Cleared 510(K)
- K050021VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT2Cleared 510(K)
- K043329OMNILUX REVIVE AND BLUE2Cleared 510(K)
- K050412VAPORMAX2Cleared 510(K)
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- K042319RELIANT LASER II SYSTEM AND ACCESSORIES2Cleared 510(K)
- K050452AURORA SR AND SRA APPLICATOR2Cleared 510(K)
- K043486PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-012Cleared 510(K)
- K050317BURANE XL2Cleared 510(K)
- K043575DERMILLUME, MODEL PRO10002Cleared 510(K)
- K043255ELLIPSE LIGHT SPT2Cleared 510(K)
- K050218WAVELIGHT SINON2Cleared 510(K)
- K043251CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B2Cleared 510(K)
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- K050069CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT2Cleared 510(K)
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- K040103SOUNDSKIN PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K041879PALOMAR LUX1064 HANDPIECE2Cleared 510(K)
- K041086PALOMAR STARLUX PULSED LIGHT SYSTEM2Cleared 510(K)
- K043429CYNERGY LASER2Cleared 510(K)
- K042000MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS2Cleared 510(K)
- K043319CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES2Cleared 510(K)
- K040270OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM2Cleared 510(K)
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- K041011ULTRALIGHT II ND:YAG LASER SYSTEM2Cleared 510(K)
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- K041957EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS2Cleared 510(K)
- K040744ATRILAZE SOFT TISSUE ABLATION SYSTEM2Cleared 510(K)
- K042968MCL 30 DERMABLATE ER:YAG LASER SYSTEM2Cleared 510(K)
- K042918MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E22Cleared 510(K)
- K041242CANDELA SMOOTHBEAM LASER SYSTEM2Cleared 510(K)
- K043012OMNIPULSE MINI, MODEL 21202Cleared 510(K)
- K041323PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA2Cleared 510(K)
- K042211MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS2Cleared 510(K)
- K041959POLARIS DS/COMET2Cleared 510(K)
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- K041969AURORA DS2Cleared 510(K)
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- K042439AZURYT MODEL CLT 1401, CO2 SURGICAL LASER SYSTEM2Cleared 510(K)
- K041994MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K041767COOLCUBE COOLPEN2Cleared 510(K)
- K042474ARION2Cleared 510(K)
- K041739EDWARDS E360 SURGICAL ABLATION DEVICE2Cleared 510(K)
- K040921COOLTOUCH, MODEL NS 1602Cleared 510(K)
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- K041930VARILITE LASER SYSTEM2Cleared 510(K)
- K042139VISULAS YAG III2Cleared 510(K)
- K041660TRIMEDYNE HOLMIUM LASER SYSTEMS2Cleared 510(K)
- K041829FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS2Cleared 510(K)
- K041419LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM2Cleared 510(K)
- K041262DURALITE-GL2Cleared 510(K)
- K041721LVI AESTHETIC LASER2Cleared 510(K)
- K041710VERSAWAVE DENTAL ER:YAG LASER SYSTEM2Cleared 510(K)
- K041103ACNELIFT2Cleared 510(K)
- K030290PERIOLASE ND:YAG DENTAL LASER SYSTEM2Cleared 510(K)
- K031140WATERLASE2Cleared 510(K)
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- K040617RELIANT LASER SYSTEM II2Cleared 510(K)
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- K041095PHOTOSILK PULSED LIGHT SYSTEM2Cleared 510(K)
- K040433SINON2Cleared 510(K)
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- K040294LASERPRO DIODE LASER SYSTEMS, MODELS 810, 940 & 9802Cleared 510(K)
- K030810COOLAN 3002Cleared 510(K)
- K040289SMARTLITE D FREQUENCY DOUBLED ND:YAG LASER2Cleared 510(K)
- K040727CRYO 52Cleared 510(K)
- K040131COOLTOUCH; COOLTOUCH II; AND COOLTOUCH CT3 ND:YAG LASER SYSTEM2Cleared 510(K)
- K033183RECLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM00122Cleared 510(K)
- K040055POLYLASE LP2Cleared 510(K)
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- K040234LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM2Cleared 510(K)
- K040081PALOMAR LUXV HANDPIECE2Cleared 510(K)
- K033072LUCENTLITE, MODEL IMD 0102Cleared 510(K)
- K034011GEMINI SURGICAL LASER SYSTEM & ACCESSORIES2Cleared 510(K)
- K040005PROFILE 2000/3000 LASER SYSTEM2Cleared 510(K)
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- K032864CERALAS D 810 DIODE LASER SYSTEM, MODEL D152Cleared 510(K)
- K032863CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D502Cleared 510(K)
- K033933POWERLITE 600 EX SYSTEM2Cleared 510(K)
- K033549STARLUX PULSED LIGHT SYSTEM2Cleared 510(K)
- K032459PROFILE 1320 LASER SYSTEM2Cleared 510(K)
- K033251THE FRIENDLYLIGHT ND: YAG LASERS2Cleared 510(K)
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- K033962LAD (EPITURE EASYTOUCH), MODEL LAD-082Cleared 510(K)
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- K034030APOGEE ELITE2Cleared 510(K)
- K030523WATERLASE2Cleared 510(K)
- K032514AC APPLICATOR, AURORA AC2Cleared 510(K)
- K032667FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW)2Cleared 510(K)
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- K033331CANDELA CBEAM PULSE DYE LASER SYSTEM2Cleared 510(K)
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- K030834CANDELA SMOOTHBEAM LASER SYSTEM2Cleared 510(K)
- K031671POLARIS WR2Cleared 510(K)
- K032383MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K033237VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE2Cleared 510(K)
- K032260ARAMIS II DERMATOLOGICAL LASER2Cleared 510(K)
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- K031795RELIANT LASER SYSTEM2Cleared 510(K)
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- K031819DIO-DENT 10 DENTAL DIODE LASER2Cleared 510(K)
- K032599MEDICAL LASER TECHNOLOGIES, LLC MTL ERBIUM:YAG LASER SYSTEM2Cleared 510(K)
- K033181SPR SYSTEM2Cleared 510(K)
- K032703INNOVATECH STRAIGHT LASER PROBE, MODEL 420-102Cleared 510(K)
- K032704INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-302Cleared 510(K)
- K032220ADEPT 1064/532 LASER2Cleared 510(K)
- K032221ADEPT 1064/755 LASER2Cleared 510(K)
- K032218ADEPT 1064/532/755 LASER2Cleared 510(K)
- K032565CYNOSURE PHOTOGENICA VL2Cleared 510(K)
- K030539LASERSMILE2Cleared 510(K)
- K032357NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES2Cleared 510(K)
- K031125CYNOSURE SMART FILE ND:YAG LASERS2Cleared 510(K)
- K032085GREEN LASER PHOTOCOAGULATOR MODEL GYC-10002Cleared 510(K)
- K032805MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT2Cleared 510(K)
- K032023W.O.M. LASER U100PLUS2Cleared 510(K)
- K031440SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER2Cleared 510(K)
- K031389CYNOSURE SMART 2940D ER:YAG LASER2Cleared 510(K)
- K031960INTRALASE FS LASER2Cleared 510(K)
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- K031805BLU-U, MODEL 41702Cleared 510(K)
- K031954COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS2Cleared 510(K)
- K032204MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT2Cleared 510(K)
- K032191OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM2Cleared 510(K)
- K031489PITANGA2Cleared 510(K)
- K031993AURORA SR2Cleared 510(K)
- K031988AURORA DS2Cleared 510(K)
- K031451XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL70002Cleared 510(K)
- K030033LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES2Cleared 510(K)
- K030426OMNILUX RED2Cleared 510(K)
- K030342LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS2Cleared 510(K)
- K031690CYNOSURE YAG FAMILY LASER (PHOTOGENICA YAG AND ACCLAIM)2Cleared 510(K)
- K031258CYNOSURE PHOTOLIGHT PL2Cleared 510(K)
- K024204FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM2Cleared 510(K)
- K031680SPECTRAPULSE2Cleared 510(K)
- K024259PULSED LIGHT THERAPY SYSTEM, MODEL# UV-3002Cleared 510(K)
- K024189NLITE SYSTEM, MODEL#: A00-1025/A00-10332Cleared 510(K)
- K030897SKINSTATION2Cleared 510(K)
- K024093MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS2Cleared 510(K)
- K031233ANDIODYNAMICS, INC. ELVS PROCEDURE KIT2Cleared 510(K)
- K030883OMNILUX BLUE2Cleared 510(K)
- K030654VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT2Cleared 510(K)
- K023881PROFILE 1064 LASER SYSTEM2Cleared 510(K)
- K031488CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASER2Cleared 510(K)
- K030700CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT2Cleared 510(K)
- K031317SMART 2940 D ER: YAG LASER2Cleared 510(K)
- K031184COOL TOUCH 32Cleared 510(K)
- K030805MYTHOS 5002Cleared 510(K)
- K030527LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS2Cleared 510(K)
- K030508DEPILASE TRIO LASE LASER SYSTEM2Cleared 510(K)
- K030510DEPILASE TWIN YAG LASER SYSTEM2Cleared 510(K)
- K030480L600 HAIR REMOVAL2Cleared 510(K)
- K030453COOLTOUCH ND: YAG LASER SYSTEM2Cleared 510(K)
- K031224SMARTXIDE2Cleared 510(K)
- K030506DEPILASE YAG LASE PLUS LASER SYSTEM2Cleared 510(K)
- K030423POWERLITE 600 EP SYSTEM2Cleared 510(K)
- K023734ARAMIS II DERMATOLOGICAL LASER2Cleared 510(K)
- K030959BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-1002Cleared 510(K)
- K030235F1 DIODE LASER SYSTEM2Cleared 510(K)
- K030181INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM2Cleared 510(K)
- K030147LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS2Cleared 510(K)
- K023547DIOLASE 980 D LASER SYSTEM2Cleared 510(K)
- K030186POLRIS LV2Cleared 510(K)
- K024371CANDELA GENTLE LASE FAMILY OF LASER SYSTEM2Cleared 510(K)
- K023257ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX2Cleared 510(K)
- K024260CANDELA GENTLELASE FAMILY OF LASER SYSTEMS2Cleared 510(K)
- K023954ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES2Cleared 510(K)
- K022923CANDELA GENTLE YAG LASER SYSTEM2Cleared 510(K)
- K024335CANDELA GENTLELASE FAMILY OF LASER SYSTEMS2Cleared 510(K)
- K024061PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.002Cleared 510(K)
- K023899DUAL YELLOW LASER, MODEL D10B2Cleared 510(K)
- K022709MEDLITE Q-SWITHCED LASER2Cleared 510(K)
- K030338ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM00022Cleared 510(K)
- K024064POLARIS DS2Cleared 510(K)
- K022807MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA2Cleared 510(K)
- K023967PALOMAR Q-YAG ND:YAG LASER SYSTEM2Cleared 510(K)
- K023624SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-69212Cleared 510(K)
- K022951CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG2Cleared 510(K)
- K022341TERABYTE 2000 HAIR REMOVER2Cleared 510(K)
- K022884CANDELA SMOOTHBEAM LASER SYSTEM2Cleared 510(K)
- K023464VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR2Cleared 510(K)
- K021222LAD, MODEL LAD-012Cleared 510(K)
- K024088CERALAS D 980 LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT, MODEL: D15 AND D252Cleared 510(K)
- K022466PROFILE 1320 LASER SYSTEM2Cleared 510(K)
- K023962NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-1602Cleared 510(K)
- K023193CANDELA GENTLE YAG LASER SYSTEM2Cleared 510(K)
- K022607SPECTRAPULSE
- K023081PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION)2Cleared 510(K)
- K023041W.O.M. LASER U1002Cleared 510(K)
- K021548FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM2Cleared 510(K)
- K023543EVLT KIT AND D15PLUS AND D30PLUS DIODE2Cleared 510(K)
- K022837FOTONA TANDEM LASER SYSTEM2Cleared 510(K)
- K022839FOTONA DUALIS PLUS ND:YAG LASER SYSTEM2Cleared 510(K)
- K022838FOTONA DUALIS ER:YAG/KTP LASER SYSTEM2Cleared 510(K)
- K022817COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II2Cleared 510(K)
- K022464EQUILASE SYSTEM2Cleared 510(K)
- K021444CYNOSURE PHOTOGENICA SV2Cleared 510(K)
- K022760MILLENNIUM MICROSURGICAL SYSTEM2Cleared 510(K)
- K022655TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH2Cleared 510(K)
- K022610CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 11602Cleared 510(K)
- K022583FLASH 12Cleared 510(K)
- K022060LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE ACCESSORIES2Cleared 510(K)
- K020339DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEM2Cleared 510(K)
- K023182INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS2Cleared 510(K)
- K022381PROFILE 1320 LASER SYSTEM2Cleared 510(K)
- K022378PLASMALITE PULSED LIGHT SYSTEM2Cleared 510(K)
- K022351DIODENT DENTAL LASER SYSTEM2Cleared 510(K)
- K022327NOVUS SPECTRA2Cleared 510(K)
- K022338OPTICAL INTEGRITY GENERAL SHAPED FIBER2Cleared 510(K)
- K020839QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, VX, DL2Cleared 510(K)
- K022226ALTUS MEDICAL FAMILY OF COOLGLIDE LASERS, MODELS COOLGLIDE I, COOLGLIDE II, AND FUTURE MODELS2Cleared 510(K)
- K022228FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES2Cleared 510(K)
- K014128CANDELA SMOOTHBEAM LASER SYSTEM2Cleared 510(K)
- K022266AURORA SR2Cleared 510(K)
- K022181NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES2Cleared 510(K)
- K013974RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A2Cleared 510(K)
- K021975LASERSYSTEM BEAUTYSTAR 5322Cleared 510(K)
- K021946CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEM2Cleared 510(K)
- K021848CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, 11602Cleared 510(K)
- K022569PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONS2Cleared 510(K)
- K022568PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIR2Cleared 510(K)
- K022544DORNIER MEDILAS H LASER FIBER CABLES2Cleared 510(K)
- K02169620G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF252Cleared 510(K)
- K021686LASER FIBER GF5002Cleared 510(K)
- K021724DORNIER DIODE LASER FAMILY, INCLUDING MEDILAS D FIBERTOM, MEDILAS D SKINPULSE & MEDILAS D SKINPULSE S LASER SYSTEMS2Cleared 510(K)
- K021650ATHOSCAN FOR THE ATHOS LASER CONSTANS COOLING HAND PIECE FOR THE ATHOS LASER2Cleared 510(K)
- K013623CLEARLIGHT PHOTOTHERAPHY SYSTEM, MODEL CL 4202Cleared 510(K)
- K013691CERALAS D DIODE LASER SYSTEM, MODEL # D502Cleared 510(K)
- K021550LUMENIS SELECTA DUET2Cleared 510(K)
- K021508OPUSDUO EC DENTAL LASER SYSTEM2Cleared 510(K)
- K021304PROLITE PULSED LIGHT SYSTEM2Cleared 510(K)
- K021616DELIGHT DENTAL ER: YAG LASER SYSTEM2Cleared 510(K)
- K021149AURORA DS2Cleared 510(K)
- K021180CANDELA VBEAM PULSED DYE LASER SYSTEM2Cleared 510(K)
- K020021LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION)2Cleared 510(K)
- K021227SOFTLASE G2-SURGICAL DIODE LASER SYSTEM2Cleared 510(K)
- K020958CANDELA CBEAM PULSED DYE LASER SYSTEM2Cleared 510(K)
- K020941PALOMAR LUXG HANDPIECE2Cleared 510(K)
- K020856SPATOUCH PHOTOEPILATION SYSTEM2Cleared 510(K)
- K020835CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-602Cleared 510(K)
- K020729NLITE SYSTEM,MODEL A00-10512Cleared 510(K)
- K014040FAMILY OF ALTUS MEDICAL MODIFIED COOLGLIDE AESTHETIC LASERS, MODELS COOLGLIDE I, II AND FUTURE MODELS2Cleared 510(K)
- K020673WAVE FORM MANUFACTURING PROLASE GENERAL SHAPED FIBER2Cleared 510(K)
- K013021LIGHTLANCE LASER SKIN PERFORATOR2Cleared 510(K)
- K020849APEX 800 LASER SYSTEM, MODEL APEX 8002Cleared 510(K)
- K020847XTRAC EXCIMER LASER SYSTEM, MODEL AL70002Cleared 510(K)
- K020513EPY-502Cleared 510(K)
- K020453PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER2Cleared 510(K)
- K013300MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM2Cleared 510(K)
- K020697DEPILASE TWIN YAG LASER SYSTEM2Cleared 510(K)
- K020099MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE2Cleared 510(K)
- K020072ATHOS LASER2Cleared 510(K)
- K020071VIRIDIS DERMA LASER2Cleared 510(K)
- K020973EX-308 EXCIMER LASER FOR PHOTOTHERAPY TREATMENT OF VITILIGO2Cleared 510(K)
- K014272PERIOLASE ND:YAG DENTAL LASER SYSTEM2Cleared 510(K)
- K014253DERMACHILLER 42Cleared 510(K)
- K014236CLINICON WAVEGUIDE PLATFORM WITH INTERCONNECT FOR LUXAR ACCESSORIES2Cleared 510(K)
- K013201CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR2Cleared 510(K)
- K014057DERMASTAR ER:YAG LASER SYSTEM2Cleared 510(K)
- K014035COOLTOUCH AND COOLTOUCH-II ND:YAG LASER SYSTEMS2Cleared 510(K)
- K020463DEPILASE YAG LASE PLUS LASER SYSTEM2Cleared 510(K)
- K013941PULSION FS LASER KERATOME2Cleared 510(K)
- K013216DIODENT DENTAL LASER SYSTEM2Cleared 510(K)
- K013940LASER SYSTEM YELLOWSTAR2Cleared 510(K)
- K020412DEPILASE TWIN LASE LASER SYSTEM2Cleared 510(K)
- K013825CANDELA SMOOTHBEAM LASER SYSTEM2Cleared 510(K)
- K014048CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS2Cleared 510(K)
- K013748CANDELA SCLERO LONG PULSE LASER (AKA VBEAM)2Cleared 510(K)
- K013864MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-602Cleared 510(K)
- K020107SMARTEPIL2Cleared 510(K)
- K012398DIOMED 15 DIODE LASER2Cleared 510(K)
- K014234MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER2Cleared 510(K)
- K013461NLITE SYSTEM,MODEL A00-10252Cleared 510(K)
- K014130NLITE SYSTEM2Cleared 510(K)
- K014100OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND2Cleared 510(K)
- K013366PROLITE PULSED LIGHT SYSTEM FOR THE REMOVAL OF UNWANTED HAIR2Cleared 510(K)
- K013365PROLITE PULSED LIGHT SYSTEM FOR THE TREATMENT OF PIGMENTED LESIONS AND THE REMOVAL OF TATTOOS2Cleared 510(K)
- K011939FOTONA DUALIS, FOTONA DUALIS PLUS2Cleared 510(K)
- K013193MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE2Cleared 510(K)
- K011960LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S4)2Cleared 510(K)
- K013901MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM)2Cleared 510(K)
- K013493INDIGO OPTIMA LASER SYSTEM2Cleared 510(K)
- K013028PALOMAR SLP 10002Cleared 510(K)
- K013047FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM2Cleared 510(K)
- K012071ENT LASERVISION2Cleared 510(K)
- K010771PERIOLASE ND:YAG DENTAL LASER SYSTEM2Cleared 510(K)
- K012806CYNOSURE PHOTOGENICA VL2Cleared 510(K)
- K011322DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE2Cleared 510(K)
- K013499DIOMED 15 PLUS AND DIOMED 30PLUS LASERS2Cleared 510(K)
- K012790CYNOSURE PHOTOGENICA ER2Cleared 510(K)
- K013402VISULAS 532S2Cleared 510(K)
- K012682REPROCESSED LASER PROBE2Cleared 510(K)
- K011174PARADIGM-FONTONA PEROVSKITE ND: YAP LASER SYSTEM AND ACCESSORIES2Cleared 510(K)
- K011070DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR2Cleared 510(K)
- K012552SCITON IMAGE HAIR REMOVAL LASER2Cleared 510(K)
- K012545ARAMIS DERMATLOGIC LASER2Cleared 510(K)
- K011175W.O.M. LASER U1002Cleared 510(K)
- K013043CANDELA CLEARBEAM PULSED DYE LASER2Cleared 510(K)
- K011021LASER 202Cleared 510(K)
- K012127PULSEMASTER ERBIUM DENTAL LASER SYSTEM2Cleared 510(K)
- K010804MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS2Cleared 510(K)
- K010715AL-402Cleared 510(K)
- K012982COOLTOUCH VARIZOOM2Cleared 510(K)
- K010618PALOMAR DERMALUX PULSED LIGHT SYSTEM2Cleared 510(K)
- K011828CYNOSURE ACCLAIM DERMATOLOGY LASER2Cleared 510(K)
- K011769OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND2Cleared 510(K)
- K011747PALOMAR LC 100 DIODE LASER2Cleared 510(K)
- K011703LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES2Cleared 510(K)
- K002890INTRALASE 600C LASER KERATOME2Cleared 510(K)
- K011423INPULSE DENTAL LASER2Cleared 510(K)
- K011382XTRAC EXCIMER LASER SYSTEM, MODEL AL 70002Cleared 510(K)
- K011207LASER PERIPHERALS REUSABLE HOLMIUM FIBER2Cleared 510(K)
- K011092CANDELA SPTL-1E PULSED DYE LASER2Cleared 510(K)
- K011041WATERLASE, MILLENNIUM2Cleared 510(K)
- K011677MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER2Cleared 510(K)
- K010927MODIFICATION TO PROLITE PULSED LIGHT SYSTEM2Cleared 510(K)
- K010928PROLITE VL PULSED LIGHT SYSTEM2Cleared 510(K)
- K011409SLT LASERPRO CTH HOLMIUM LASER SYSTEM2Cleared 510(K)
- K010885UNI-LASER 4702Cleared 510(K)
- K010580PALOMAR SLP 10002Cleared 510(K)
- K003318PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X2Cleared 510(K)
- K010834LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES2Cleared 510(K)
- K010689MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM2Cleared 510(K)
- K010316COOLTOUCH VARIA ND:YAG LASER SYSTEM; COOLTOUCH VARIA-II ND:YAG LASER SYSTEM2Cleared 510(K)
- K010284LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)2Cleared 510(K)
- K003440SOFTLASE - SURGICAL DIODE LASER SYSTEM2Cleared 510(K)
- K010113LASER MECHANISMS LASER SCANNING SYSTEM2Cleared 510(K)
- K010104CANDELA LONG PULSE ND:YAG2Cleared 510(K)
- K010046NUVOLASE 532 MEDICAL LASER SYSTEM2Cleared 510(K)
- K010005CYNOSURE PHOTOGENICA DL2Cleared 510(K)
- K004039CYNOSURE PHOTOGENICA NEO-V2Cleared 510(K)
- K004021F1 DIODE LASER SYSTEM2Cleared 510(K)
- K003993DORNIER MEDILAS D SKINPULSE LASER SYSTEM (SKINPULSE)2Cleared 510(K)
- K004006SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER2Cleared 510(K)
- K004014MD 30 COMPACT2Cleared 510(K)
- K003953INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF0012Cleared 510(K)
- K003952INDIGO LASEROPTIC TREATMENT SYSTEM2Cleared 510(K)
- K003955LASEREX INTEGRE, MODEL LP25322Cleared 510(K)
- K003614LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM2Cleared 510(K)
- K010041SLT DIFFUSER FIBER2Cleared 510(K)
- K003765LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)2Cleared 510(K)
- K010285CONTOUR PROFILE LASER2Cleared 510(K)
- K003886PALOMAR SPALIGHT PULSED LIGHT SYSTEM2Cleared 510(K)
- K003715COOLTOUCH ND:YAG LASER SYSTEM, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH II2Cleared 510(K)
- K003705XTRAC EXCIMER LASER SYSTEM, MODEL AL70002Cleared 510(K)
- K003885VISULAS YAG II2Cleared 510(K)
- K003541DENLASER, MODEL 8002Cleared 510(K)
- K003460PALOMAR CLEAR LIGHT ND: YAG LASER SYSTEM2Cleared 510(K)
- K003385TWILITE, TWILITE WHITE2Cleared 510(K)
- K003202FAMILY OF ALTUS MEDICAL COOLGLIDE AESTHETIC LASERS, MODELS I & II2Cleared 510(K)
- K003151MICROPOBE SERIES OF LASERS AND ACCESSORIES2Cleared 510(K)
- K003781COOLTOUCH VARIA-II ND:YAG LASER SYSTEM2Cleared 510(K)
- K002308OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A2Cleared 510(K)
- K003147LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION)2Cleared 510(K)
- K002899OPUS 20, MODEL 1ST2Cleared 510(K)
- K002884PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES2Cleared 510(K)
- K002853SCITON IMAGE HAIR REMOVAL LASER2Cleared 510(K)
- K001211MODIFICATION TO INTRALASE 600C LASER KERATOME2Cleared 510(K)
- K003046IMAGE VASCULAR LASER2Cleared 510(K)
- K002649ARAMIS DERMATOLOGICAL LASER2Cleared 510(K)
- K000023FRIENDLY LIGHT ER:YAG PULSED LASER2Cleared 510(K)
- K002421CANDELA MID IR DIODE LASER SYSTEM2Cleared 510(K)
- K001676OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A2Cleared 510(K)
- K000317SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM2Cleared 510(K)
- K001990DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES2Cleared 510(K)
- K000929PROLITE PULSED LIGHT SYSTEM2Cleared 510(K)
- K002228PHOTON MODULAR WORKSTATION SYSTEM, MODELS Z-12834-X & Z-13175-X2Cleared 510(K)
- K002296CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G152Cleared 510(K)
- K001093CANDELA SPTL-1B PULSED DYE LASER2Cleared 510(K)
- K000727BUFFLIGHT CLT SURGICAL LASER SYSTEM2Cleared 510(K)
- K002072PROLITE VL PULSED LIGHT SYSTEM2Cleared 510(K)
- K002032C02 LASER MULTIPULSE2Cleared 510(K)
- K001784VIRIDIS LASER2Cleared 510(K)
- K001704ATHOS2Cleared 510(K)
- K000811NLITE SYSTEM, SLS MODEL NUMBER A00-10252Cleared 510(K)
- K000158VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B92Cleared 510(K)
- K001589CANDELA DYNAMIC COOLING DEVICE2Cleared 510(K)
- K002347COOLTOUCH II2Cleared 510(K)
- K001975CERALAS D10 810NM LASER, MODEL CERALAS D10-602Cleared 510(K)
- K001527FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES2Cleared 510(K)
- K990119EPI-STAR SURGICAL LASER SYSTER2Cleared 510(K)
- K001746LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM (FAMILY OF PRODUCTS)2Cleared 510(K)
- K001511O-LAS OPHTHALMIC PHOTODISRUPTOR2Cleared 510(K)
- K993328SURGILIGHT, INC EXCIMER LASER2Cleared 510(K)
- K001322PERFORMER 30 HPS2Cleared 510(K)
- K001031URANUS, COMFORTOUCH LASER SYSTEM2Cleared 510(K)
- K993154LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM2Cleared 510(K)
- K992757CYNOSURE APOGEE-TKS DERMATOLOGICAL LASER2Cleared 510(K)
- K000990OPUS 10 DENTAL DIODE LASER2Cleared 510(K)
- K000072DORNIER MEDILAS D SKINPULSE2Cleared 510(K)
- K994116LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM)2Cleared 510(K)
- K994260CANDELA GENTLELASE GL DERMATOLOGICAL LASER2Cleared 510(K)
- K001243DORNIER MEDILAS H2Cleared 510(K)
- K994225PALOMAR SLP 20002Cleared 510(K)
- K000693UMECO OPTIMA MULTILINE LASER SYSTEM2Cleared 510(K)
- K000503MEDART 520 COOLING SYSTEM2Cleared 510(K)
- K993815UNI-LASER 4302Cleared 510(K)
- K001263SHARPLAN LASERS, INC. PULSED CTH:YAG HOLMIUM SURGICAL LASER, MODEL 20402Cleared 510(K)
- K000805KAVO K.E.Y. LASER 12422Cleared 510(K)
- K000982A100 AESTHETIC DIODE LASER2Cleared 510(K)
- K992597LORAD LT-100 LASER TREATMENT SYSTEM2Cleared 510(K)
- K000222UM-L252Cleared 510(K)
- K000106DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES2Cleared 510(K)
- K000192E3 MICROPROB SERIES OF LASERS AND ACCESSORIES2Cleared 510(K)
- K000490CYNOSURE PHOTOGENICA VLS-STAR2Cleared 510(K)
- K000498COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER2Cleared 510(K)
- K990718ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)2Cleared 510(K)
- K991798ACME MEDICAL AESTHETIC ND:YAG LASER2Cleared 510(K)
- K994014ESC INTENSE PULSED LIGHT SYSTEMS: EPILIGHT AND MULTILIGHT2Cleared 510(K)
- K993834SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C2Cleared 510(K)
- K993911CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D502Cleared 510(K)
- K993828CERALAS D10 810NM DIODE LASER2Cleared 510(K)
- K992914EXCIMER LASER PHOTOTHERAPY SYSTEM, AL70002Cleared 510(K)
- K991935EPILIGHT HAIR REMOVAL SYSTEM, PHOTODERM HR SYSTEM2Cleared 510(K)
- K993671CANDELA SCLERO LONG PULSE DYE LASER2Cleared 510(K)
- K994273MODEL 1000 HOLMIUM LASER SYSTEM2Cleared 510(K)
- K994437CYNOSURE PHOTOGENICA SPIR2Cleared 510(K)
- K994427CYNOSURE M2 DERMATOLOGY LASER FOR HAIR REMOVAL2Cleared 510(K)
- K993942LITESABER 20002Cleared 510(K)
- K992482DELIGHT II HAIR REMOVAL SYSTEM (THE DELIGHT SYSTEM)2Cleared 510(K)
- K993209SOFTLIGHT Q-SWITCHED ND: YAG LASER WITH OPTIONAL BEAM-SHRINKING HANDPIECE ACCESSORY2Cleared 510(K)
- K994010INNOVAQUARTZ GENERAL SHAPE LASER FIBER2Cleared 510(K)
- K993153INTRALASE 600C LASER KERATOME2Cleared 510(K)
- K992298IRIDERM, MODEL APEX 8002Cleared 510(K)
- K993285AURORA SL2Cleared 510(K)
- K992866OPTILITE IX LASER SURGERY ACCESSORIES2Cleared 510(K)
- K992824LASEREX ND:YAG OPHTHALMIC LASER (LQ2106), ALCON ND:YAG OPHTHALMIC LASER (3000LE), LASEREX ND:YAG OPHTHALMIC LASER, MODEL2Cleared 510(K)
- K991993PHACOLASE ER: YAG LASER2Cleared 510(K)
- K993146DORNIER SCANNER HANDPIECE2Cleared 510(K)
- K992574OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A2Cleared 510(K)
- K992707MCL 29 DERMABLATE ER:YAG LASER SYSTEM2Cleared 510(K)
- K993002CERALAS D 980NM DIODE LASER SYSTEM, MODEL D152Cleared 510(K)
- K992536TECHNOSANAT KRYO TSK 20052Cleared 510(K)
- K992374AURORA HL2Cleared 510(K)
- K992814CYNOSURE ACCOLADE LASER2Cleared 510(K)
- K992630THERMALIGHT 20002Cleared 510(K)
- K991994TWILIGHT2Cleared 510(K)
- K992765CYNOSURE DIODERM2Cleared 510(K)
- K992472SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEM2Cleared 510(K)
- K992013DEL2940 DENTAL ERBIUM LASER, DELITE DENTAL ERBIUM LASER2Cleared 510(K)
- K992773CERALAS D10 810NM DIODE LASER2Cleared 510(K)
- K990903LYRA SERIES SURGICAL SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)2Cleared 510(K)
- K992620BLULAZE2Cleared 510(K)
- K992508TSX PROBE, OCULAR CONTACT PROBE;TSX PROBE,OCULAR CONTACT PROBE,SMA2Cleared 510(K)
- K982860UM-L20/ UM-L302Cleared 510(K)
- K991634FOTONA NOVALIS R RUBY LASER SYSTEM2Cleared 510(K)
- K991632FOTONA NOVALIS ER: YAG LASER SYSTEM2Cleared 510(K)
- K991628MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA2Cleared 510(K)
- K992061PULSTAR2Cleared 510(K)
- K990914POLARIS DIODE LASER SYSTEM AND ACCESSORIES2Cleared 510(K)
- K990680DENTEC LD 15 DIODE LASER2Cleared 510(K)
- K991659UNI-LASER 425P DIODE LASER SYSTEM & ACCESSORIES2Cleared 510(K)
- K991464DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-502Cleared 510(K)
- K992230OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP2Cleared 510(K)
- K992084CYNOSURE SURESCAN WITH THE CO3 ER: YAG LASER2Cleared 510(K)
- K992083SCATTERFREE LATERAL EMITTING FIBER2Cleared 510(K)
- K991297UNI-LASER 450P CO2 LASER SYSTEM & ACCESSORIES2Cleared 510(K)
- K991285LASER SYSTEM RUBYSTAR WITH Q-SWITCH AND NORMAL MODE2Cleared 510(K)
- K991234THE ACME MEDICAL AESTHETIC ND:YAG LASER2Cleared 510(K)
- K991891CERALAS DIODE LASER SYSTEM, MODEL CERALAS D152Cleared 510(K)
- K991183DORNIER LASERTRODE FIBER2Cleared 510(K)
- K990243FOTONA FIDELIS ER:YAG LASER SYSTEM & ACCESSORIES2Cleared 510(K)
- K983984COOLTOUCH V ND:YAG2Cleared 510(K)
- K990902MODIFICATION OF MLT R694 RUBY LASER SYSTEM2Cleared 510(K)
- K990568SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO LASER PROBE BENT TIP, MODEL 59.012Cleared 510(K)
- K991258NOVUS VERDI DELIVERY SYSTEMS2Cleared 510(K)
- K984486PULSEMASTER DENTAL LASER SYSTEM2Cleared 510(K)
- K990748EDGE SYSTEMS STERILE TUBING2Cleared 510(K)
- K990452ORLIGHT 2000 SURGICAL LASER SYSTEM2Cleared 510(K)
- K990947MODIFIED VERSAPULSE SELECT SINGLE WAVELENGTH, HO: YAG AND DUAL WAVELENGTH, HO: YAG/ND: YAG SURGICAL LASERS AND DELIVERY2Cleared 510(K)
- K990417DERMACOOL2Cleared 510(K)
- K982940LIGHTSHEER PULSED DIODE ARRAY LASER SYSTEM2Cleared 510(K)
- K990174ATLAS-ELITE,MODEL E-80,CORIUM 200,CORIUM 400, MODEL E-90, ELITE, MODEL E-80-II, ELITE ULTRA, MODEL E-80-IV2Cleared 510(K)
- K983524LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS PEIOLASE FOR LASERENAP)2Cleared 510(K)
- K990851INDIGO LASEROPTIC TREATMENT SYSTEM2Cleared 510(K)
- K984591DORNIER MEDILAS H/22Cleared 510(K)
- K990780NUVOLASE 532 CUTANEOUS LASER SYSTEM2Cleared 510(K)
- K990725NUVOLASE 532 LASER SYSTEM2Cleared 510(K)
- K980840LOKKI DT2Cleared 510(K)
- K984424AURA DYE LASER SYSTEM (ADLS)2Cleared 510(K)
- K982980LIGHTSHEER LONG PULSE RUBY LASER2Cleared 510(K)
- K990014DIOSCAN2Cleared 510(K)
- K984339MEDART 455 SCANNER SYSTEM2Cleared 510(K)
- K990043SMOOTHLASE ALEXANDRITE LASER SYSTEM2Cleared 510(K)
- K983054MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND: YAG LASER2Cleared 510(K)
- K984601CANDELA GENTLELASE II DERMATOLOGICAL LASER2Cleared 510(K)
- K984349DORNIER MEDILAS R2Cleared 510(K)
- K982119DIODE LASER2Cleared 510(K)
- K983950CERALAS DIODE LASER SYSTEM (MODEL H)2Cleared 510(K)
- K983868OPMI TWINER SURGICAL MICROSCOPE2Cleared 510(K)
- K983100KAVO KEY LASER 12422Cleared 510(K)
- K984517CYNOSURE ERASURE LASER2Cleared 510(K)
- K983673LASETTE2Cleared 510(K)
- K983654CYBER-LASE 2000 CURING AND WHITENING LASER2Cleared 510(K)
- K983977LIGHT AGE EPICARE ALEXANDRITE LASER2Cleared 510(K)
- K983965CO2 LASER COUPLER2Cleared 510(K)
- K984110LASERSCOPE COOLSPOT2Cleared 510(K)
- K983543ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM2Cleared 510(K)
- K982316LASEAWAY ALEXANDRITE LASER SYSTEM2Cleared 510(K)
- K980475UNIPULSE CO2 SURGICAL LASER SYSTEM2Cleared 510(K)
- K983463SURECAUT DIAMOND LASER KNIFE2Cleared 510(K)
- K981746CELL ROBOTICS' LASETTE2Cleared 510(K)
- K983215MULTIPULSE CO2 LASER2Cleared 510(K)
- K983963DORNIER MEDILA H2Cleared 510(K)
- K983020COMPACT KTP LASER2Cleared 510(K)
- K981379AURORA2Cleared 510(K)
- K983058CERALAS D LASER SYSTEM, MODEL # CERALAS D152Cleared 510(K)
- K982548MLT 30 LASER2Cleared 510(K)
- K983211CENTAURI2Cleared 510(K)
- K982113UMECO OPTIMA 694 RUBY LASER SYSTEM2Cleared 510(K)
- K982230LASETTE LASER SKIN PERFORATOR2Cleared 510(K)
- K980398KAPLAN PENDULASER 115 SURGICAL LASER WITH OPTOSCAN II2Cleared 510(K)
- K982827DERMA K ER:YAG/CO2 LASER2Cleared 510(K)
- K982629DORNIER MEDILAS D2Cleared 510(K)
- K981143DILKES LASER/SUCTION CANNULAE2Cleared 510(K)
- K983034CYNOSURE CO3 ER:YAG LASER2Cleared 510(K)
- K982031OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE2Cleared 510(K)
- K981952COMBINATION ND:YAG AND FREQUENCY DOUBLED SOLID STATE GREEN LASER2Cleared 510(K)
- K980559PEGASUS ND:YAG LASER SYSTEM2Cleared 510(K)
- K982295NIDEK LIGHTSCAN2Cleared 510(K)
- K981627PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE)2Cleared 510(K)
- K980389MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES2Cleared 510(K)
- K980517EPILASER NORMAL MODE RUBY LASER2Cleared 510(K)
- K981438DORNIER MEDILAS E2Cleared 510(K)
- K981718DORNIER MEDILAS H2Cleared 510(K)
- K972575800 SERIES SURGICAL LASER SYSTEM ORION SERIES SURGICAL LASER SYSTEM ANGLED DELIVERY DEVICES2Cleared 510(K)
- K970069DUAL HOOK FIBEROPTIC DELIVERY SYSTEM2Cleared 510(K)
- K974586AURORA DIODE LASER SYSTEM2Cleared 510(K)
- K981351CANDELA GENTLELASE GL DERMATOLOGICAL LASER2Cleared 510(K)
- K981350ALEXIS ALEXANDRITE LASER SYSTEM AND ACCESSORIES2Cleared 510(K)
- K980538LASER LANCET LB1002Cleared 510(K)
- K980501SKINTONER SYSTEM2Cleared 510(K)
- K981149LASETTE LASER SKIN PERFORATOR2Cleared 510(K)
- K980753CHROMOSCAN SCANNING SYSTEM2Cleared 510(K)
- K981126CERALAS G FREQUENCY DOUBLED ND: YAG LASER SYSTEMS, CERALAS G32Cleared 510(K)
- K974641FUTURELASE 3000/3002 ERBIUM LASER SYSTEM2Cleared 510(K)
- K981447DIO-LIGHT 60 LASER SYSTEM2Cleared 510(K)
- K980838REUSABLE MEGABEAM FIBER OPTIC DELIVERY SYSTEM2Cleared 510(K)
- K980710SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 DP ALEXANDRITE LASER SYSTEM2Cleared 510(K)
- K980685MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS2Cleared 510(K)
- K974536PHOTODERM HR SYSTEM2Cleared 510(K)
- K980547NIDEK PRIMA MODEL GYC-1500/20002Cleared 510(K)
- K971207SOFTLIGHT Q-SWITCHED (ND:YAG) LASER2Cleared 510(K)
- K980420LIGHTSHEER2Cleared 510(K)
- K980784SURETOUCH2Cleared 510(K)
- K974674CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM2Cleared 510(K)
- K981090LASERLITE DIODE SURGICAL LASER2Cleared 510(K)
- K980361DERMABLATE ER: YAG LASER SYSTEM2Cleared 510(K)
- K974057DENTEK LD 15 LASERSYSTEM2Cleared 510(K)
- K972548SLT CL MD CONTACT LASER SYSTEM2Cleared 510(K)
- K980537ND: YAG ACCESSORY FOR PHOTODERM SYSTEM2Cleared 510(K)
- K980187MLT R694 RUBY LASER SYSTEM2Cleared 510(K)
- K980142FEATHERLITE DIODE LASER2Cleared 510(K)
- K980560FOTONA SKINPLUS LASER SYSTEM2Cleared 510(K)
- K974896LASERSCOPE EL LASER SYSTEM AND ACCESSORIES2Cleared 510(K)
- K974878E3 MICROPROBE2Cleared 510(K)
- K980561DERMIUM2Cleared 510(K)
- K980313SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE2Cleared 510(K)
- K980001JENASCAN2Cleared 510(K)
- K974732NIDEK MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-70002Cleared 510(K)
- K980201DIO-LIGHT LASER SYSTEM2Cleared 510(K)
- K980160EPILASER I UPGRADE KIT2Cleared 510(K)
- K974789COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L2Cleared 510(K)
- K980156SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS2Cleared 510(K)
- K974900CYNOSURE PHOTOGENICA 532 LASER2Cleared 510(K)
- K980131ALEX TA2 ERASER2Cleared 510(K)
- K974381CANDELA GENTLELASE GL DERMATOLOGICAL LASER2Cleared 510(K)
- K974229LS-905 FIBERCHOICE ADAPTER SYSTEM2Cleared 510(K)
- K973867SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 LASER SYSTEM2Cleared 510(K)
- K973172RESPOSABLE BARE FIBERS2Cleared 510(K)
- K974142HM-RUBY2Cleared 510(K)
- K974633SCANTECH LASER SCANNER2Cleared 510(K)
- K974460LITE TOUCH ERBIUM LASER TREATMENT SYSTEM2Cleared 510(K)
- K974346STARLIGHT PULSED DIODE ARRAY LASER SYSTEM2Cleared 510(K)
- K974039SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE2Cleared 510(K)
- K973828PRIMA KTP LASER SYSTEM2Cleared 510(K)
- K973764TEMPERATURE DIAGNOSTIC ACCESSORY2Cleared 510(K)
- K973719MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASER2Cleared 510(K)
- K963969INDIGO PORTABLE LASER SYSTEM WITH TEMPERATURE FEEDBACK -MODEL IDL 830 (POWER OPTIONS : 25, 20, 15 & 10 WATTS) INDIGO FIB2Cleared 510(K)
- K973603SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 1064/532 LASER SYSTEM2Cleared 510(K)
- K972915ERBIUM 2000 LASER FAMILY2Cleared 510(K)
- K971118ARAGO2Cleared 510(K)
- K973470COHERENT POPEYE OPHTHALMIC LASER SYSTEM, COHERENT POPEYE OPHTHALMIC LASER SYSTEM IN COMBINATION WITH THE COHERENT ARGONS2Cleared 510(K)
- K973576EPULSE MODEL 2940 ER:ASER ER:YAG LASER SYSTEM2Cleared 510(K)
- K973354SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)2Cleared 510(K)
- K972767CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER2Cleared 510(K)
- K973324STARLIGHT PULSED DIODE ARRAY LASER SYSTEM2Cleared 510(K)
- K973498CYNOSURE PHOTOGENICA ER LASER2Cleared 510(K)
- K971912PROTEGE ER:YAG LASER SYSTEM AND ACCESSORIES2Cleared 510(K)
- K970143C42Cleared 510(K)
- K973431LASETTE2Cleared 510(K)
- K972872DERMA K LASER SYSTEM2Cleared 510(K)
- K972028DERMASCAN SURGICAL LASER SCANNER2Cleared 510(K)
- K972765NUVOLASE 720 SYSTEM FOR OPHTHALMOLOGY LASER2Cleared 510(K)
- K972561NUVOLASE 660 LASER SYSTEM FOR OPHTHALMOLOGY2Cleared 510(K)
- K970475MM-RUBY2Cleared 510(K)
- K971821UNICA 315 M CO2 SURGICAL LASER SYSTEM2Cleared 510(K)
- K972368FOTONA SKINLIGHT PLUS ND: YAG SYSTEM2Cleared 510(K)
- K972347MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER2Cleared 510(K)
- K972325PULSEMASTER 1000 ST DENTAL LASER SYSTEM2Cleared 510(K)
- K970808MEDLITE IV Q-SWITCHED, FREQUENCY DOUBLED, ND:YAG LASER2Cleared 510(K)
- K972099SHARPLAN EPITOUCH RUBY LASER SYSTEM2Cleared 510(K)
- K972002CYNOSURE DERMATOLOGY LASER COOLING TIP2Cleared 510(K)
- K971903SCANNING DEVICE ACCESSORY FOR USE WITH THE CB DIODE/532 ND:YAG LASER2Cleared 510(K)
- K971874SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000)2Cleared 510(K)
- K971879SCANNING DEVICE ACCESSORY FOR USE WITH THE CB ERBIUM/2.94 ER:YAG LASER2Cleared 510(K)
- K971830ACCU-PULSE CARBON DIOXIDE LASER SYSTEM2Cleared 510(K)
- K965124LASETTE2Cleared 510(K)
- K971737CYNOSURE PHOTOGENICA LPIR DERMATOLOGICAL LASER2Cleared 510(K)
- K964831SURESCAN2Cleared 510(K)
- K971814IMPROVEMENTS TO THE MEHL RUBY LASER2Cleared 510(K)
- K972272LASER PERIPHERALS HOLMIUM BARE FIBERS2Cleared 510(K)
- K971843LASERSCOPE VELA ERBIUM:YAG LASER SYSTEM AND ACCESSORIES2Cleared 510(K)
- K971648SHARPLAN ERBIUM: YAG LASER (4020)2Cleared 510(K)
- K971743SHARPLAN CO2 SURGICAL LASER SYSTEM2Cleared 510(K)
- K971459DERMALASE2Cleared 510(K)
- K965128CYNOSURE PHOTOGENICA VLV CUTANEOUS VASCULAR LESION LASER2Cleared 510(K)
- K970461CELL ROBOTICS ER: YAG SURGICAL LASER2Cleared 510(K)
- K971404SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE 2940 ERBIUM LASER2Cleared 510(K)
- K963249EPILIGHT HAIR REMOVAL SYSTEM2Cleared 510(K)
- K971250LASERSCOPE MICROBEAM IV MICROMANIPULATOR2Cleared 510(K)
- K971193LASEAWAY LONG PULSE AND Q-SWITCHED RUBY LASER SYSTEM2Cleared 510(K)
- K971065DENTICA PULSED ND: YAG LASER SYSTEMS AND ACCESSORIES2Cleared 510(K)
- K971024SOFTSCAN2Cleared 510(K)
- K964818ORION SERIES SURGICAL LASER SYSTEM (Q-SWITCHED ND:YAG CONFIGURATION)2Cleared 510(K)
- K970934CB ERBIUM/2.94(TM) ER:YAG LASER2Cleared 510(K)
- K965180STRAIGHTFIRE REUSABLE OPTICAL FIBERS (400,600,800,1000)2Cleared 510(K)
- K971539NOVATIP FAMILY OF LASER HANDPIECE TIPS2Cleared 510(K)
- K970804TRU-PULSE CO2 SURGICAL LASER2Cleared 510(K)
- K970243CYNOSURE DLS-10-810 DIODE LASER GENERAL PHOTOCOAGULATOR2Cleared 510(K)
- K970948800 SERIES SURGICAL LASER SYSTEM AND ACCCESSORIES2Cleared 510(K)
- K970667NUVO-LASE 660 LASER SYSTEM2Cleared 510(K)
- K963340MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECE2Cleared 510(K)
- K970757FOTONA SKINSCAN2Cleared 510(K)
- K933841CENTAURI2Cleared 510(K)
- K932683CENTAURI2Cleared 510(K)
- K963991FSI LAPAROSCOPIC PROBE FOR ALL FSI ULE-OVERCLAD FF201 FIBERS2Cleared 510(K)
- K963996(FSI) LAPAROSCOPIC PROBE FOR ALL FSI ULE FF101 FIBERS. MODEL FSI FF101-LP-XXX, WHERE XXX = FIBER DIAMETERS 100, 200, 4002Cleared 510(K)
- K970422RIGHT ANGLE LASER FIBERS;OPTILASE ND:YAG LASER;OPTILASE PL100 ND LASER SYSTEMS2Cleared 510(K)
- K964585RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE)2Cleared 510(K)
- K964253DERMA 20 LASER SYSTEM2Cleared 510(K)
- K955653VENISECT LASER LANCET2Cleared 510(K)
- K970157LASERSCOPE AUTOMATIC EYE PROTECTION FILTER2Cleared 510(K)
- K970637ACCUCURE 10002Cleared 510(K)
- K964074DIOLITE 5322Cleared 510(K)
- K970361LASER EYE GOGGLES2Cleared 510(K)
- K970017NIDEK CYBERSCAN2Cleared 510(K)
- K964128MCL 29 DERMABLATE ERBIUM LASER SYSTEM2Cleared 510(K)
- K961380CPC PROBE2Cleared 510(K)
- K965015TOPAZ 30 SURGICAL LASER SYSTEM2Cleared 510(K)
- K962791NEW STAR MODEL 130 6-WATT ND: YAG LASER SYSTEM2Cleared 510(K)
- K962109SLS CHROMOS 694 QD RUBY LASER TO BE RENAMED MEHL QD RUBY LASER SYSTEM FOR HAIR REMOVAL2Cleared 510(K)
- K961269PULSEMASTER2Cleared 510(K)
- K962446SHARPLAN RUBY LASER SYSTEM2Cleared 510(K)
- K963947EPILASER NORMAL MODE RUBY LASER2Cleared 510(K)
- K964353CYBERLASE CO2 LASER SYSTEM2Cleared 510(K)
- K963081INDIGO MEDICAL MODEL IDL 830 & MODEL IDL 830E LASER SYSTEMS FOR GENERAL GYNECOLOGICAL APPLICATIONS2Cleared 510(K)
- K964760DORNIER MEDILAS FIBER TOME LASER2Cleared 510(K)
- K964486ACCUCURE 30002Cleared 510(K)
- K964684SOFTOUCH2Cleared 510(K)
- K963683TRU-PULSE LASER (MODIFIED)2Cleared 510(K)
- K964520PARASCAN SCANNING DEVICE2Cleared 510(K)
- K964497CERALAS DIODE LASER SYSTEM (CERALAS D15)2Cleared 510(K)
- K961560ECLIPSE 20002Cleared 510(K)
- K963339COHERENT ULTRAPULSE CO2 SURGICAL LASERS2Cleared 510(K)
- K962632OMNIPULSE/OMNIPULSE-MAX2Cleared 510(K)
- K962902FOTONA SKINLIGHT LASER SYSTEM2Cleared 510(K)
- K962965LIGHTSTIC MODEL 3602Cleared 510(K)
- K964076LASERSCOPE ERBIUM; YAG LASER SYSTEM AND ACCESSORIES2Cleared 510(K)
- K964031DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM2Cleared 510(K)
- K963094CYNOSURE PHOTOGENICA LP DERMATOLOGICAL VASCULAR LESION LASER2Cleared 510(K)
- K964211DAVOL PLUME FILTER (5541420)2Cleared 510(K)
- K963389FLEX-LASE 600 SERIES ION LASER SYSTEM2Cleared 510(K)
- K963193ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG392Cleared 510(K)
- K963124PC LASER WITH SMART PLUG (PC EDO & DENTAL 200)2Cleared 510(K)
- K962068LIGHTSTIC MODEL 1802Cleared 510(K)
- K963229SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS2Cleared 510(K)
- K961935SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNER2Cleared 510(K)
- K961705AOC MEDICAL SYSTEM MODEL PHASE II 50 SURGICAL DIODE LASER SYSTEM2Cleared 510(K)
- K961710AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SYSTEM2Cleared 510(K)
- K962993CYNOSURE PHOTOAPPEAL CO2 SURGICAL LASERS2Cleared 510(K)
- K962948CERALAS G ND;YAG LASER SYSTEM (CERALAS G)2Cleared 510(K)
- K962592OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS2Cleared 510(K)
- K962354DIOMED 15, 30, 60 SURGICAL DIODE LASER2Cleared 510(K)
- K961006MEDLITE/755 ALEXANDRITE LASER SYSTEM2Cleared 510(K)
- K960772PHOTODERM PL.2Cleared 510(K)
- K962242SURESCAN2Cleared 510(K)
- K962974SHARPLAN LASERS, INC. AF ACUSPOT MICROMANIPULATOR (713)2Cleared 510(K)
- K960636LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER2Cleared 510(K)
- K961682ARGON CURING LASER2Cleared 510(K)
- K961748MEDLITE/ERBIUM LASER SYSTEM2Cleared 510(K)
- K955612RD-1200H NORMAL MODE RUBY LASER SYSTEM2Cleared 510(K)
- K961516LASER PERIPHERALS INC. BARE FIBER2Cleared 510(K)
- K961279SHARPLAN LASERS, INC. RUBY LASER SYSTEM2Cleared 510(K)
- K955662CANDELA Q-SWITCHED ALEXANDRITE LASERS2Cleared 510(K)
- K961136PULSEMASTER2Cleared 510(K)
- K960905SDL DIODE LASER SYSTEM2Cleared 510(K)
- K960086DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM2Cleared 510(K)
- K961079LASER PERIPHERALS INC. SCATTERFREE FIBER2Cleared 510(K)
- K960821SLT FUMICH PROBE GUIDE2Cleared 510(K)
- K960867FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(VIRIDIS) FREQUENCY DOUBLED ND:YAG PHOTOCOAGULATOR(EVERGREEN 532)2Cleared 510(K)
- K960768LASER FIBER DELIVERY/CLEANING CATHETER2Cleared 510(K)
- K960820SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNER2Cleared 510(K)
- K960521SHARPLAN LASERS, INC. SILKTOUCH FLASH SCANNER2Cleared 510(K)
- K960475MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM2Cleared 510(K)
- K960579CYNOSURE PHOTOGENICA VL CUTANEOUS VASCULAR LESION LASER2Cleared 510(K)
- K960413COHERENT SLIMLINE SINGLE LUMEN ASPIRATION NEEDLE KIT2Cleared 510(K)
- K960032COHERENT VERSAPULSE AESTHETIC SURGICAL LASERS2Cleared 510(K)
- K954905CB DIODE/532 LASER SYSTEM2Cleared 510(K)
- K951935PRODIGY SUPERPULSE ND:YAG SURGICAL LASER SYSTEMS & ACCESSORIES2Cleared 510(K)
- K951876PROTEGE ER:YAG SURGICAL LASER SYSTEM AND ACCESSORIES2Cleared 510(K)
- K954597RIGHT ANGLE LASER FIBERS2Cleared 510(K)
- K955862FULL SPECTRUM ULE-OVERCLAD FIBER: MODEL 2012Cleared 510(K)
- K955621SHARPLAN LASERS, INC SILKTOUCH 2 FLASH SCANNER2Cleared 510(K)
- K955131MEDLITE LASER SYSTEM2Cleared 510(K)
- K955758INDIGO MEDICAL MODEL IDL 830E2Cleared 510(K)
- K953851CERALAS F ND:YAG LASER SYSTEM2Cleared 510(K)
- K955734LASERSONICS PARASCAN DOSIMETER DEVICE2Cleared 510(K)
- K954727SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM (MODIFICATION)2Cleared 510(K)
- K953585SCHWARTZ ELECTRO-OPTICES, INC. TRILASE 2100/20 HOLMIUM LASER2Cleared 510(K)
- K954934CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE2Cleared 510(K)
- K954013TRILASE 2940 ERBIUM LASER2Cleared 510(K)
- K955861MICROQUARTZ MEDICAL TYPE B SIDE-FIRING LASER FIBER2Cleared 510(K)
- K955007APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTEM2Cleared 510(K)
- K955014APPLIED OPTRONICS MODEL AOC 25 SURGICAL DIODE2Cleared 510(K)
- K953670ACCUSCAN MODEL C CO2 LASER SCANNER2Cleared 510(K)
- K954195INDIGO PORTABLE LASER SYSTEM, INDDIGO FIBEROPTICS2Cleared 510(K)
- K954911OMEGA ULTRASCAN2Cleared 510(K)
- K954904MICROQUARTZ MEDICAL GENERAL SHAPE LASER FIBER2Cleared 510(K)
- K9524896 WATT HOLMIUM LASER SYSTEM2Cleared 510(K)
- K955006ECLIPSE 21002Cleared 510(K)
- K954834CERALAS G FREQUENCY DOUBLED ND;YAG LASER SYSTEM2Cleared 510(K)
- K951910ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIES2Cleared 510(K)
- K954931NEO-MED DLS-11002Cleared 510(K)
- K954460ILT SURGICAL LASER2Cleared 510(K)
- K954316AURORA SURGICAL DIODE LASER SYSTEM W/ACCESSORIES2Cleared 510(K)
- K953800MLT 202Cleared 510(K)
- K951760OPTILITE VIII LASER SURGERY ACCESSORIES2Cleared 510(K)
- K950826AM RUBY2Cleared 510(K)
- K952277SHARPLAN MODEL 2040 PULSED CTH:YAG SURGICAL LASER SYSTEM2Cleared 510(K)
- K953794SHARPLAN LASERS, INC. SURGICAL DIODE LASER2Cleared 510(K)
- K952682LOKKI DT2Cleared 510(K)
- K954544LASER GAS MIXTURE2Cleared 510(K)
- K953917LASESONICS LOW POWER CO2 LASER SYSTEM2Cleared 510(K)
- K953412CANDELA MODEL PLTL-1 LASER SYSTEM2Cleared 510(K)
- K951117LIHTAN 532 LASER2Cleared 510(K)
- K952661SLT THERMALITE DIODE LASER SERIES, DIODE 980, 810, 9402Cleared 510(K)
- K952046LMT 20 AA LASER SURGICAL SYSTEM2Cleared 510(K)
- K952047LMT 40 AA LASER SURGICAL SYSTEM2Cleared 510(K)
- K952045LMT 20 HH LASER SURGIVAL SYSTEM2Cleared 510(K)
- K950996DORNIER THERMAFOCUS 360 FIBER2Cleared 510(K)
- K953065ULTRABRIGHT (MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER)2Cleared 510(K)
- K952796ADVANCED LASER MULTILINE SYSTEM, ALY2Cleared 510(K)
- K953494TAPERTIP MULTISUE HOLMIUM ARTHROSCOPIC HANDPIECE, VARIOUS ENDFIRING MODELS, WITH/OUT A STERILIZABLE INSTRUMENT TRAY2Cleared 510(K)
- K952755POWERSCULPTOR PROBES2Cleared 510(K)
- K953933MED-TECH LASER GAS MIXTURE2Cleared 510(K)
- K953174MICROQUATZ MEDICAL LINEAR MODULATOR ACCESSORY2Cleared 510(K)
- K953074MODIFIED LUXAR LX-20 FAMILY CO2 LASER SYSTEM2Cleared 510(K)
- K952974QUADRALASE (MICROQUARTZ MEDICAL ADJUSTABLE SIDE-FIRING LASER FIBER)2Cleared 510(K)
- K952554SCHWARTZ ELECTRO-OPTICS, INC. TRILASE LASER SYSTEM2Cleared 510(K)
- K950825AM-YAG2Cleared 510(K)
- K953658CORSSFIRE PLUS2Cleared 510(K)
- K952216SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM & WCE DIFFUSER FLAT PROBE DF 22Cleared 510(K)
- K950684CYNOSURE PHOTOGENICA T10 TATTOO REMOVAL LASER2Cleared 510(K)
- K953424ECLIPSE 32002Cleared 510(K)
- K950120SMART PLUG2Cleared 510(K)
- K952118ELMER2Cleared 510(K)
- K950493PHOTODERM VL.2Cleared 510(K)
- K952733SIDEFIRE - TIPPED REUSABLE OPTICAL FIBERS2Cleared 510(K)
- K952754SACS, INDEPENDENT FIBER COOLANT SYSTEM2Cleared 510(K)
- K952636MEDLITE LASER SYSTEM2Cleared 510(K)
- K952049TRU-PULSE PULSED CO2 SURGICAL LASER SYSTEM2Cleared 510(K)
- K951562OMNIPULSE-MAX HOLMIUM LASER2Cleared 510(K)
- K952813SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM2Cleared 510(K)
- K952772MEGABEAM ENDO-ENT PROBE2Cleared 510(K)
- K952299SURGISCAN SCANNER2Cleared 510(K)
- K951775CERALAS DIODE LASER SYSTEM (MODEL CERALAS D50)2Cleared 510(K)
- K951714CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER2Cleared 510(K)
- K951812MODIFIED COHERENT ULTRAPULSE CO2 SURGICAL LASERS2Cleared 510(K)
- K952598GX-PAN PANORAMIC DENTAL X-RAY SYSTEM2Cleared 510(K)
- K950215ACUTOME(R) 150 MULTI-WAVELENGTH COLOR-CORRECTED(TM) LASER HANDPIECE2Cleared 510(K)
- K952340MEGABEAM ASPIRATING ENDOCULAR PROBE2Cleared 510(K)
- K951165SHARPLAN MODEL 3100 ND:YAG SURGICAL LASER SYSTEM2Cleared 510(K)
- K952301LASER GAS MIXTURE2Cleared 510(K)
- K952162MEDICAL MIXTURE-LASER GAS MIXTURES2Cleared 510(K)
- K952113TBN-TIPPED OPTICAL FIBER2Cleared 510(K)
- K951204SHARPLAN MODEL 712 ACUSPOT MICROMANIPULATOR2Cleared 510(K)
- K945564MODEL 550-DC CROSSFIRE(TM)2Cleared 510(K)
- K952006ACCU-BEAM FIBER OPTIC HANDPIECE2Cleared 510(K)
- K951933UROTEK RE-USABLE FIBEROPTIC CABLE2Cleared 510(K)
- K950831ALEXLAZR2Cleared 510(K)
- K945614ADD POWER FAMILY , MICRO ADDSTAT2Cleared 510(K)
- K931490SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM FAMILY2Cleared 510(K)
- K944558ELLMAN VAPOR-VAC II2Cleared 510(K)
- K943411ACCUCURE 30002Cleared 510(K)
- K951215LASERSONICS ULTRALINE III STERILE DISPOSABLE FIBER2Cleared 510(K)
- K950819SLT SIDEFIRING REFRACTIVE FIBER (HIGH POWER DENSITY FIBER)2Cleared 510(K)
- K951034AURA LASER SYSTEM2Cleared 510(K)
- K950725SHARPLAN MODEL 1015 CO2 LASER2Cleared 510(K)
- K950019THERMOLASE LT-100 ND:YAG LASER HAIR REMOVAL SYSTEM; THERMOLASE LT-100;LT-1002Cleared 510(K)
- K951045LASER GAS MIXTURE2Cleared 510(K)
- K950351CL-5500 (UNMODIFIED DEVICE) PRECISION CURING UNIT (PCU) (MODIFIED OPTION)2Cleared 510(K)
- K950313KAPLAN PENDULASER 115 - A 15W CO2 SURGICAL LASER2Cleared 510(K)
- K946386CANDELA RUBY LAZE Q-SWITCHED RUBY LASER2Cleared 510(K)
- K942622LASEAWAY Q-SWITCHED ND:YAG LASER SYSTEM2Cleared 510(K)
- K945228125MM HANDPIECE2Cleared 510(K)
- K946304COHERENT FAMILY OF CO2 SURGICAL LASER SCANNER HANDPIECES2Cleared 510(K)
- K944437DISPOSABLE LASER SWEEP TIP2Cleared 510(K)
- K943716LASERSONICS SURGICAL LASER SYSTEMS AND ACCESSORIES2Cleared 510(K)
- K950710MICROQUARTZ MEDICAL SIDE-FIRING LASER FIBER2Cleared 510(K)
- K950661CANDELA 10MM CIRCULAR SPOT LASER HANDPIECE2Cleared 510(K)
- K950662DERMASTAT, MICRONSPOT, MACROSPOT, FOCALSTAT2Cleared 510(K)
- K945156SLASE 210 PLUS HOLMIUM LASER SYSTEM2Cleared 510(K)
- K943292CANDELA SPTL VARIABLE PULSE/TUNABLE PULSED DYE LASERS2Cleared 510(K)
- K943638USDL MODEL SELECT 1000 FREQUENCY DOUBLED ND:YAG LASER SYSTEM2Cleared 510(K)
- K943201CLEAN AIR2Cleared 510(K)
- K95050550MM HANDPIECE2Cleared 510(K)
- K950248LASERSPRAY(TM)2Cleared 510(K)
- K945648ACCU-BEAM C02 LASER HANDPIECE2Cleared 510(K)
- K945178TOUCH FOCUS 200MM DEFOCUSING HANDPIECE2Cleared 510(K)
- K946336MEGABEAM FIBER OPTIC DELIVERY SYSTEM2Cleared 510(K)
- K931286SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM2Cleared 510(K)
- K945888MODIFIED LUXAR LX-20 FAMILY C02 LASER SYSTEM2Cleared 510(K)
- K944928PY30, PY60, PY802Cleared 510(K)
- K945181GENERA 100 SURGICAL SYSTEM2Cleared 510(K)
- K945560UROTEK LASER CATHETER2Cleared 510(K)
- K945126ECLIPSE 32002Cleared 510(K)
- K944965OPTILITE VI FIBEROPTIC ACCESSORIES2Cleared 510(K)
- K944704OPTILITE (TM) VII FIBEROPTIC ACCESSORIES ROTALASE (TM) ANGLE DELIVERY SYSTEMSN AND ACCESSORIES2Cleared 510(K)
- K946002ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRA2Cleared 510(K)
- K944758SUNRISE TECHNOLOGIES MODEL 5020 PLDD KIT2Cleared 510(K)
- K944749OPTICA 100 SUPERPULSED LASER SYSTEM2Cleared 510(K)
- K942935ACUTOME 100 COLOR-CORRECTED CO2 LASER HANDPIECE2Cleared 510(K)
- K945563CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM))2Cleared 510(K)
- K944474OPTILITE V FIBEROPTIC ACCESSORIES2Cleared 510(K)
- K941838MULTIPLE CO2 LAERS2Cleared 510(K)
- K943045UNIMAX MODEL 2500 MULTIWAVELENGTH COLOR CORRECTED2Cleared 510(K)
- K942729LIHTAN 4100 KRYPTON2Cleared 510(K)
- K945587CANDELA ELLIPTICAL SPOT HANDPIECE2Cleared 510(K)
- K940173CANDELA Q-SWITCHED ALEXANDRITE LASER2Cleared 510(K)
- K943527MEGABEAM LATERAL FIRE2Cleared 510(K)
- K943543MEDICAL OPTICS CO2 SURGICAL LASER SYSTEMS2Cleared 510(K)
- K931445KTP/532, KTP/YAG AND KTP/YAG XP2Cleared 510(K)
- K945054ENDOCARE PROLASE I ADVANCED LASER DELIVERY SYSTEM2Cleared 510(K)
- K944204LATERALASE, MODIFIED2Cleared 510(K)
- K942868ACUTOME 2000 COLOR-CORRECTED LAPAROSCOPIC C02 LASER COUPLER AND SLEEVES2Cleared 510(K)
- K944630MODEL 230-SAS LASER DELIVERY PROBE2Cleared 510(K)
- K944153ECLIPSE 32002Cleared 510(K)
- K944977COAXIAL ENDOSTAT2Cleared 510(K)
- K944346LASERSONICS RADIANCE DIODE LASER SYSTEMS AND ACCESSORIES2Cleared 510(K)
- K921995CANDELA H:ERB LASER2Cleared 510(K)
- K944625MODEL 210-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER2Cleared 510(K)
- K944628MODEL 220-SS LASER DELIVERY PROBE2Cleared 510(K)
- K944629MODEL 230-SAC LASER DELIVERY PROBE2Cleared 510(K)
- K944626MODEL 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER2Cleared 510(K)
- K944627MODEL 220-SC CURVED ENDOPHOTOCOAGULATOR LASER2Cleared 510(K)
- K944471STRAIGHT ENDOPHOTOCOAGULATOR LASER PROBE2Cleared 510(K)
- K944470CURVED ENDOPHOTOCOAGULATOR LASER PROBE2Cleared 510(K)
- K941559PARADERM -585M DERMATOLOGICAL LASER2Cleared 510(K)
- K945143DENTAL LASER FIBER SYSTEM2Cleared 510(K)
- K944631MODEL 120-SC LASER DELIVERY PROBE2Cleared 510(K)
- K944621MODEL 110-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER2Cleared 510(K)
- K944622MODEL 110-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER2Cleared 510(K)
- K944624MODEL 130-SAC ASPIRATING ENDOPHOTOCOAGULATOR LASER2Cleared 510(K)
- K944623MODEL 130-SAS ASPIRATING ENDOPHOTOCOAGULATOR LASER2Cleared 510(K)
- K944632MODEL 120-SS LASER DELIVERY PROBE2Cleared 510(K)
- K944472CURVD ENDOPHOTOCOGULATOR LASER PROBE2Cleared 510(K)
- K944282LASER DELIVERY PROBE2Cleared 510(K)
- K944151OPTICAL FIBER FOR ENT APPLICATIONS2Cleared 510(K)
- K933057MULTILITE ERBIUM:YAG SURGICAL LASER SYSTEM2Cleared 510(K)
- K944317GENESIS 20002Cleared 510(K)
- K944206GENESIS 20002Cleared 510(K)
- K944091THE HOOK-CURVED CLOSED END/ELECT FIBER LASER DELIV SYS2Cleared 510(K)
- K944090CANDELA ALEX LAZR Q-SWITCHED ALEXANDRITE LASER2Cleared 510(K)
- K943479GENEMED YAG 1000 MEDICAL LASER2Cleared 510(K)
- K942934CONBIO CUB-D10 COOPER LASER SYSTEM2Cleared 510(K)
- K943171CROSSFIRE(TM) (705-10650)2Cleared 510(K)
- K942786KARL STORZ LASER ACCESSORIES2Cleared 510(K)
- K920596FULL SPECTRUM ULE FIBER, MODEL FF1012Cleared 510(K)
- K942542SLASE 210 PLUS HOLMIUM LASER SYSTEM2Cleared 510(K)
- K934811PLTL-1 & PLDL-1 510NM PULSED DYE LASERS2Cleared 510(K)
- K942759OPTICON(TM) CONNECTOR ADAPTER II2Cleared 510(K)
- K934501LASER PHOTONICS ML755 DERMABLASER2Cleared 510(K)
- K943526MEGABEAM LATERAL FIRE FIBER OPTIC DELIVERY SYSTEM2Cleared 510(K)
- K943445MEGABEAM FIBER OPTIC DELIVERY SYSTEM2Cleared 510(K)
- K943444MEGABEAM LATERAL FIRE2Cleared 510(K)
- K942204ARGON CURING LASER2Cleared 510(K)
- K934208SLT PRISM/REFRACTING PROBE2Cleared 510(K)
- K933918SHARPLAN MODEL 1080S CO2 SURGICAL LASER2Cleared 510(K)
- K943409SIDE-FIRING UROLOGIC REFRACTIVE FIBER2Cleared 510(K)
- K942865LASER GAS MIXTURE2Cleared 510(K)
- K935631CONBIO MEDALEX LASER SYSTEM2Cleared 510(K)
- K943693PULSEMASTER S SERIES2Cleared 510(K)
- K941841SMARTSCAN2Cleared 510(K)
- K943491RIGHT ANGLE UROLOGIC LASER FIBER2Cleared 510(K)
- K942217PULSEJET DENTAL LASER SYSTEM2Cleared 510(K)
- K915236IRIS G-PROBE2Cleared 510(K)
- K942152CANDELA Q-SWITCHED, FREQUENCY DOUBLED ND;YAG LASER SY2Cleared 510(K)
- K943311ECLIPSE 32002Cleared 510(K)
- K942343LASEAWAY Q-SWITCHED RUBY LASER SYSTEM2Cleared 510(K)
- K933318COHERENT VERSAPULSE 2.1U /1.06U COMPACT SURGICAL LASER, MODELS A & B2Cleared 510(K)
- K942182MEGABEAM DENTAL FIBER2Cleared 510(K)
- K942439ZEISS OPMILAS 144 SURGICAL LASERS2Cleared 510(K)
- K941312SHARPLAN SWIFTLASE 765/766/767 FLASHSCAN2Cleared 510(K)
- K941419DISPOSABLE SPINAL INTRODUCER SHEATH2Cleared 510(K)
- K932883OPTILASE MODEL 1000-100 ND: YAG LASER SYSTEM2Cleared 510(K)
- K940461ALEXANTRIPTOR2Cleared 510(K)
- K940636CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM2Cleared 510(K)
- K940607CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM2Cleared 510(K)
- K941909MEGA BEAM LATERAL FIRE2Cleared 510(K)
- K936109SHARPLAN MODEL 1120 CO2 SURGICAL LASER2Cleared 510(K)
- K935563SHARPLAN SURGICAL CO2 LASERS AND ACCESSORIES2Cleared 510(K)
- K934211CYTOCARE DIODE LASER SYSTEM2Cleared 510(K)
- K941694ISL QC 2000 LASER2Cleared 510(K)
- K934865OMNIPULSE MODEL 1210-VHP HO:YAG LASER SYSTEM2Cleared 510(K)
- K932981COHERENT VERSAPULSE 2.1 HOLMIUM SURGICAL LASERS2Cleared 510(K)
- K934706CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATULAZR2Cleared 510(K)
- K933245ULTRALINE II STERILE DISPOSABLE FIBER2Cleared 510(K)
- K933211D'AMICO\PEYMAN FLUTED ENDOPROBE2Cleared 510(K)
- K935495PF404/409/410/411/416/418 W/PF319:0/319:1/319:22Cleared 510(K)
- K934209SLT REFLECTING PROBE2Cleared 510(K)
- K933362SHARPLAN CO2 SURGICAL LASER2Cleared 510(K)
- K934486COOL LASER OPTICS (CLO) UNIT2Cleared 510(K)
- K935305CYNOSURE PHOTOTOME SURGICAL DIODE LASER2Cleared 510(K)
- K932062OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR2Cleared 510(K)
- K931762CANDELA SPTL PULSED DYE LASERS2Cleared 510(K)
- K925178PEGASUS2Cleared 510(K)
- K926543SHARPLAN ND:YAG SURGICAL LASER, MODEL 3060 SHARPLASER 602Cleared 510(K)
- K924258MEGABEAM RADIAL EMIT SHAPE FIBER OPTIC DELIV SYST2Cleared 510(K)
- K933140RQM-1005 INTEGULASER RUBY MEDICAL LASER SYSTEM2Cleared 510(K)
- K935775LASERSONICS CLEARPULSE MODELS 50, 70 & 100 CO2 SURGICAL LASER SYSTEMS2Cleared 510(K)
- K933525DIOMED 25 25W SURGICAL DIODE LASER2Cleared 510(K)
- K932730EXCEL'S EST-30 HO:YAG LASER SYSTEM2Cleared 510(K)
- K931264INFINITECH OTOPROBE2Cleared 510(K)
- K925414LATERALASE CATHETER2Cleared 510(K)
- K925124TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASE SYST2Cleared 510(K)
- K922496TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST2Cleared 510(K)
- K922497OPTILASE ND:YAG MODELS 1000/4000 SURG LASER SYSTEM2Cleared 510(K)
- K933880SL SERIES SURGICAL LASER SYSTEMS2Cleared 510(K)
- K923605MODIFIED SHARPLAN 10412Cleared 510(K)
- K933016CANDELA PLTL-1 LASER SYSTEM2Cleared 510(K)
- K934389UROTEK LASER CATHETER2Cleared 510(K)
- K934089BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S2Cleared 510(K)
- K932723CONBIO CUB-D10 COPPER LASER SYSTEM2Cleared 510(K)
- K935258HYBRID SURGICAL DEVICE MODIFICATION2Cleared 510(K)
- K933007SLASE 210 & SLASE 210 PLUS HOLMIUM LASER SYSTEMS2Cleared 510(K)
- K931305ECLIPSE 3200 FOR USE IN UROLOGY APPLICATIONS2Cleared 510(K)
- K934008MEGABEAM LATERAL FIRE FIBER OPTIC DELIVERY SYST2Cleared 510(K)
- K935310MEDICAL LASER MIXTURE2Cleared 510(K)
- K935034LASER GAS MIXTURE2Cleared 510(K)
- K932376ZEISS OPMILAS 144 SURGICAL LASERS2Cleared 510(K)
- K930611TRUE FLOW(TM) VALVE2Cleared 510(K)
- K934935ECLIPSE LAZERBLADE(TM) FIBEROPTIC DELIVERY SYSTEM2Cleared 510(K)
- K933715BOSTON SCIENTIFIC CORPORATION SIDE FIRING LASER GUIDE2Cleared 510(K)
- K926452ZEISS VISULAS YAG II LASER2Cleared 510(K)
- K925726ALLOY SCALPEL HANDPIECES, MODIFICATION2Cleared 510(K)
- K911288ORION2Cleared 510(K)
- K910826ORION YAG LASER SYSTEM OPHTHALMOLOGY2Cleared 510(K)
- K930582SHARPLAN SHARPLASE LATERAL ND:YAG FIBER2Cleared 510(K)
- K931776DIOMED 25 25W SURGICAL DIODE LASER2Cleared 510(K)
- K933322ZEISS OPMILAS 144 SURGICAL LASERS2Cleared 510(K)
- K932421SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASE2Cleared 510(K)
- K932156MULTILINE; DLY-12Cleared 510(K)
- K932272CLOSED END/ELECTROCAUTERY FIBEROPT LASER DELIV SYS2Cleared 510(K)
- K924720VISIDISC KITS, SPINESCOPE2Cleared 510(K)
- K931070CLOSED END FIBEROPTIC LASER DELIVERY SYSTEM2Cleared 510(K)
- K923575COHERENT VERSAPLUSE 2.1 HOLMIUM SURG. LASERS2Cleared 510(K)
- K933333HGM SCANMAN PLUS2Cleared 510(K)
- K931978SHARPLASE SHORT FIBER ND:YAG DELIVERY SYSTEM2Cleared 510(K)
- K931212DIOMED 25 25W SURGICAL DIODE LASER2Cleared 510(K)
- K932468NOVUS MULTIWAVELENGTH2Cleared 510(K)
- K914519DIOMED 25 SURGICAL DIODE LASER, GYNECOLOGY APPLIC2Cleared 510(K)
- K925642ZEISS DIODE-PUMPED SOLID STATE LASER2Cleared 510(K)
- K931101ECLIPSE 2100(TM) MODEL 32, MODIFICATION2Cleared 510(K)
- K931499Q-11 OPHTHALMIC LASER2Cleared 510(K)
- K930975DERMA-LASE DLA-1 LASER2Cleared 510(K)
- K930793MULTILINE; DLY-12Cleared 510(K)
- K920865SHARPLAN 2100,3000,SHARPLASER 65, 402Cleared 510(K)
- K930981ACCULITE(TM) OTOPROBE2Cleared 510(K)
- K930098SPECULUM SMOKE EVACUATOR TUBING2Cleared 510(K)
- K930099LASER HANDPIECE SHROUD2Cleared 510(K)
- K926210ECLIPSE 32002Cleared 510(K)
- K933017MODEL 5030 SUCTION HANDPIECE SYSTEM2Cleared 510(K)
- K931306ECLIPSE 3200 FOR USE IN ORTHO SURG/ARTH APPL JOINT2Cleared 510(K)
- K932065DLASE 300 UPGRADE2Cleared 510(K)
- K931774UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASER2Cleared 510(K)
- K926224DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS2Cleared 510(K)
- K924213ECLIPSE 2100(TM), MODIFICATION2Cleared 510(K)
- K924588ZEISS LASER INDIRECT OPHTHALMOSCOPE2Cleared 510(K)
- K925908AP01 AND AP022Cleared 510(K)
- K931051MODEL 110 ND:YAG LASER2Cleared 510(K)
- K925840ECLIPSE 32002Cleared 510(K)
- K930543E-25 KRYPTON ION LASER (SURGICA K5)2Cleared 510(K)
- K924647DLR-1 DERMA-LASE RUBY LASER/DLR-1/DERMA-LASE SYST2Cleared 510(K)
- K9308792.5 WATT PULSED DENTAL LASER SYSTEM2Cleared 510(K)
- K9307898-WATT PULSED DENTAL LASER SYSTEM2Cleared 510(K)
- K924943ECLIPSE 3200(TM) HO:YAG LASER FOR PERCU DISKETOMY2Cleared 510(K)
- K923599OPTILITE FIBEROPTIC DELIVERY SYSTEMS2Cleared 510(K)
- K924457MICROMANIPULATOR2Cleared 510(K)
- K930361ASI CYSTOLASE LASER CYSTOSCOPE2Cleared 510(K)
- K930210ACL-55002Cleared 510(K)
- K924424UNIMEDIX HOLMIUM FIBER2Cleared 510(K)
- K924160HYBRID SURGICAL DEVICE2Cleared 510(K)
- K913566ARTHROSCOPIC LUMBAR MECHANICAL AND LASER DISCECTOM2Cleared 510(K)
- K924664SURGILASE FIBERLASE CO2 LASER WAVEGUIDE2Cleared 510(K)
- K930159OPTICON(TM) CONNECTOR ADAPTER2Cleared 510(K)
- K924537LPI ML210 HOLMIUM SURGICAL LASER2Cleared 510(K)
- K922935CONBIO-MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM2Cleared 510(K)
- K922577CONBIO-MEDLITE(TM) Q-SWITCHED ND:YAG LASER SYSTEM2Cleared 510(K)
- K923274ZEISS VISULAS DIODE LASER2Cleared 510(K)
- K930490SLT MULTIDIMENSIONAL CONTACT LASER SYST A4060C2Cleared 510(K)
- K923991ZOE LASER, CONTACT ND:YAG LASER SYSTEM2Cleared 510(K)
- K923191SWITCHABLE TIP SYSTEM2Cleared 510(K)
- K920334LASERPHOTONICS ML300 STONELASER ALEXANDRITE LITH.2Cleared 510(K)
- K922213LASER-ASSISTED DISK DECOMPRESSION ACCESSORY PACK2Cleared 510(K)
- K924120MOLDED FIBER CAP DELIVERY SYSTEM2Cleared 510(K)
- K925549SLASE 210 PLUS HOLMIUM LASER SYSTEM2Cleared 510(K)
- K910825ORION YAG LASER SYSTEM EAR, NOSE, & THROAT APPLIC.2Cleared 510(K)
- K924644ENDOSTATS, MICROSTATS, ACCUSTATS2Cleared 510(K)
- K921549DORNIER FIBERTOME 100 WATT SURGICAL LASER2Cleared 510(K)
- K924166OPTILINK(TM) LPM (LASER POWER MODULATOR)2Cleared 510(K)
- K914520DIOMED 25 SURGICAL DIODE LASER, UROLOGY APPLICAT2Cleared 510(K)
- K924729EXCEL TRIPULSE MODEL30002Cleared 510(K)
- K924158CANDELA LASSER SYSTEMS MODIFIED2Cleared 510(K)
- K914521DIOMED 25 SURGICAL DIODE LASER, GEN SURG APPLICAT2Cleared 510(K)
- K923855SHARPULSE2Cleared 510(K)
- K922807FIBERLIFE2Cleared 510(K)
- K923896HERCULES MODEL 5060 AND 5100 ND:YAG LASER SYSTEMS2Cleared 510(K)
- K922901INCISOR I PULSED ND:YAG LASER SYSTEM2Cleared 510(K)
- K923953MEGABEAM2Cleared 510(K)
- K924214ECLIPSE 2100(TM) MODEL 322Cleared 510(K)
- K922881CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC2Cleared 510(K)
- K914334ALCON(R) FX2(TM) PHOTOCOAGULATOR2Cleared 510(K)
- K920708MULTILASE 2500 A2Cleared 510(K)
- K913917MULTILASE 2100 C, 2100 D2Cleared 510(K)
- K923539AMERICAN DENTAL LASER SINGLE USE CONTACT 320 HANDP2Cleared 510(K)
- K923341ZEISS VISULAS ARGON LASER2Cleared 510(K)
- K921990ASI UROPLASTY LASER CYSTOSCOPE2Cleared 510(K)
- K923683CYNOSURE PHOTOGENICA T TATTOO REMOVAL LASER2Cleared 510(K)
- K921300MODEL PC ARGON ION LASER2Cleared 510(K)
- K921708CYTOCARE LASER CATHETER FOR UROLOGY2Cleared 510(K)
- K922917ENDOPROBES2Cleared 510(K)
- K914678ODYSSEY HO:YAG SURGICAL LASER SYSTEM2Cleared 510(K)
- K913990KTP/532 & KTP/YAG2Cleared 510(K)
- K921843CYNOSURE PHOTODENT, INTRAORAL SURGICAL LASER2Cleared 510(K)
- K920673PERCUDISC PLDD DELIVERY SYSTEM/PROCEDURE KIT2Cleared 510(K)
- K922663IRIS OCULIGHT SL2Cleared 510(K)
- K921841CYNOSURE PHOTOGENICA P PIGMENTED LESION LASER2Cleared 510(K)
- K923050ND:YAG LASER-122Cleared 510(K)
- K921096LASER-62Cleared 510(K)
- K913244KTP/532 & KTP/YAG SURGICAL LASERS2Cleared 510(K)
- K914918LASERSCOPE'S MICROSPOT DERMASTAT2Cleared 510(K)
- K914136COHERENT VERSAPULSE(TM) 2.1XE/2.1L HOLMI SURG LASE2Cleared 510(K)
- K921840CYNOSURE PHOTOTRIPTER LASER2Cleared 510(K)
- K922634SLT LASER DELIVERY SYSTEM2Cleared 510(K)
- K922375EXCEL DUOPULSE MODEL 3000 COMBINATION HO/ER:YAG2Cleared 510(K)
- K921842CYNOSURE PHOTGENICA V CUTANEOUS VAS. LESION LASER2Cleared 510(K)
- K920967ZEISS MULTI YAG LASER2Cleared 510(K)
- K921320ELIOS DIODE OPHTHALMIC LASER2Cleared 510(K)
- K921298MODEL MM-2405 AND MM-2410 COPPER VAPOR LASER2Cleared 510(K)
- K921380LASERSCOPE'S DISPOSABLE LAPAROSTAT W/ FIBER DIVER2Cleared 510(K)
- K915679EXCEL DUOPAULSE MODEL 20002Cleared 510(K)
- K921807ULTRALINE STERILE DISPOSABLE FIBER2Cleared 510(K)
- K921671SURGILASE FIBERLASE VCO2 LASER WAVEGUIDE2Cleared 510(K)
- K912067POLARIS, GYNECOLOGY INDICATIONS2Cleared 510(K)
- K915651OMNIMED HOLMIUM LASER AND DELIVERY SYSTEM2Cleared 510(K)
- K915631LPI ML 100/532 AND ML 532 SURGICAL LASER2Cleared 510(K)
- K915578ND;YAG SURGICAL LASER SYSTEMS2Cleared 510(K)
- K921146SHARPLAN CO2 SURG. LASER, MO. 1039 SURGICENTER 402Cleared 510(K)
- K920659DAVOL ENDO-FLO LASER PROBE AND ACCESSORIES2Cleared 510(K)
- K920062CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LAS.2Cleared 510(K)
- K921038ECLIPSE 21002Cleared 510(K)
- K920597HANDI-LASE CO2 SURGICAL LASER INSTRUMENT2Cleared 510(K)
- K920821UNIMAX MODEL 2000 COLOR-CORRECTED MICROSPOT CO22Cleared 510(K)
- K920004PBI MULTILASE D COPPER VAPOR LASER2Cleared 510(K)
- K921596SHARPLAN C02 ULTRASWIFT VAPORIZATION ENDPIECE2Cleared 510(K)
- K914991VERSAPULSE(TM) TWOPOINTONE/XE HOLMIUM SURG LASERS2Cleared 510(K)
- K920934HALOCATH LASER CATHETERS2Cleared 510(K)
- K920589ANGLED DELIVERY DEVICE2Cleared 510(K)
- K910422MODEL RD-1200 RUBY LASER SYSTEM2Cleared 510(K)
- K910152ORION2Cleared 510(K)
- K920584SCULPTURED ENDOSTAT2Cleared 510(K)
- K920120ND:YAG SURGICAL LASER2Cleared 510(K)
- K915656CARBON DIOXIDE CO2 LASER2Cleared 510(K)
- K914197ALLOY SCALPEL HANDPIECES2Cleared 510(K)
- K914679PRODIGY ND:YAG SURGICAL LASER SYSTEM2Cleared 510(K)
- K920625LATERALASE2Cleared 510(K)
- K920632SIDE FIRING FIBERS2Cleared 510(K)
- K920529ZEISS MULTIYAG LASER2Cleared 510(K)
- K915169EXCEL MODEL XLT-TWO HOLMIUM:YAG LASER SYSTEM2Cleared 510(K)
- K915117MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM2Cleared 510(K)
- K914518KTP/YAG AND KTP/YAG PLUS2Cleared 510(K)
- K915583CO2 LASER AND WAVEGUIDE DELIVERY SYSTEMS FOR THOR.2Cleared 510(K)
- K914827LPI ML210 HOLMIUM SURGICAL LASER, MODIFICATION2Cleared 510(K)
- K920553MYRIADLASE SIDEFIRE-TIPPED OPTICAL FIBER2Cleared 510(K)
- K915840ZEISS MULTIYAG LASER2Cleared 510(K)
- K920106ADL 400 ND;YAG LASER SYSTEM FOR INTRORAL SOFT TIS.2Cleared 510(K)
- K920107ADL 800 ND:YAG LASER SYSTEM FOR INTRAORAL TIS. SUR2Cleared 510(K)
- K913839OPTICA 25 ND:YAG DENTAL LASER SYSTEM2Cleared 510(K)
- K915561ZEISS MULTIYAG LASER2Cleared 510(K)
- K914455SHARPLAN MODELS 100 SERIES C02 LASERS/ACCESSORIES2Cleared 510(K)
- K915497CONBIO MEDLITE Q-SWITCHED ND:YAG LASER SYSTEM2Cleared 510(K)
- K915085DL100 C02 SURGICAL LASER SYSTEM2Cleared 510(K)
- K912618LASER SYSTEMS FOR PERCUTANEOUS LUMBAR DISCECTOMY2Cleared 510(K)
- K914849EXCEL MODEL XLT-ONE ND:YAG LASER SYSTEM2Cleared 510(K)
- K915354LATERALASE2Cleared 510(K)
- K913290MULTILASE 2100 A2Cleared 510(K)
- K912879MODEL SLASE 210 HOLMIUM (THC:YAG) LASER SYSTEM2Cleared 510(K)
- K915768SURGI LIGHT ND:YAG LASER SYSTEM MODEL 9040302Cleared 510(K)
- K915370COPPER VAPOR LASER SYSTEM2Cleared 510(K)
- K915000ACU-GUARD2Cleared 510(K)
- K915223METAL ENCLOSED SIDE FIRING FIBERS2Cleared 510(K)
- K913256DERMA-LASE RUBY LASER - MODEL DLR-12Cleared 510(K)
- K912813SIRIUS2Cleared 510(K)
- K910823PERCUDISC(TM) SYSTEM2Cleared 510(K)
- K914396SURGI LIGHT NON-CONTACT FIBERS2Cleared 510(K)
- K914952MODEL 1210 OMNIPULSE HOLMIUM LASER SYSTEM2Cleared 510(K)
- K913606CHRYS XX CO2 SURGICAL LASER SYSTEM2Cleared 510(K)
- K915352LASER FIBEROPTIC DELIVERY SYSTEM2Cleared 510(K)
- K914726ILT CO2 SURGICAL LASER FOR ORAL SOFT TISSUE PROCED2Cleared 510(K)
- K914175MICROSURGE LASER FIBER WITH SMA CONNECTOR2Cleared 510(K)
- K913887C02 LASER WAVEGUIDE2Cleared 510(K)
- K914089SHARPLAN SHARPLASE FAMILY OF HANDSWITCHED ND:YAG2Cleared 510(K)
- K914423OPTIFIBER2Cleared 510(K)
- K913758KTP/532 AND KTP/YAG2Cleared 510(K)
- K913430IRIS OCULIGHT(R) SLX2Cleared 510(K)
- K914677MODEL DLASE 500 ND:YAG LASE SYS:INTRA SFT TIS SURG2Cleared 510(K)
- K914568MODEL DLASER 1000 ND;YAG LASER SYSTEM2Cleared 510(K)
- K911926POLARIS, OPHTHALMOLOGY2Cleared 510(K)
- K910530CARBON DIOXIDE LASER SYSTEMS W/WAVEGUIDE DELIVERY2Cleared 510(K)
- K912987CRYSTAL FOCUS EMER LASER PHOTO VIS RED OPER MODE2Cleared 510(K)
- K913465NIDEK MODELS AC-2100 & 22002Cleared 510(K)
- K913569COMPAC A, ELITE A, ELITE A PLUS, SURGICA A2Cleared 510(K)
- K913191DORNIER LASER LITHOTRIPTER IMPACT2Cleared 510(K)
- K912063POLARIS, ORAL INDICATION2Cleared 510(K)
- K912703OPTICA 60 ND;YAG SURGICAL LASER SYSTEM2Cleared 510(K)
- K911925POLARIS, GASTROENTEROLOGY/UROLOGY/PULMONARY, GI/GU2Cleared 510(K)
- K910341POLARIS2Cleared 510(K)
- K913127COHERENT NOVUS 3000 ARGON PHOTOCOAGULATOR2Cleared 510(K)
- K913109LATERALASE(TM) CATHETER WITH THERMAL FEEDBACK2Cleared 510(K)
- K914104ENDOSTAT2Cleared 510(K)
- K913918HERAEUS LASERSONICS TACTILASE STERILE DISPOS FIBER2Cleared 510(K)
- K910037COHERENT HOLMIUM:YAG SURGICAL LASER2Cleared 510(K)
- K910027CRYSTAL FOCUS EMERALD LASER SLT MCX 1.5 CONVEX PRO2Cleared 510(K)
- K912793SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM (CLS)2Cleared 510(K)
- K913564HERCULES 5000 AND HERCULES 5040 ND:YAG LASER SYSTE2Cleared 510(K)
- K912628AIR ARGON ION LASERS VARIOUS MODELS2Cleared 510(K)
- K913513LATERALASE STERILE DISPOSABLE FIBER2Cleared 510(K)
- K913488STI CONTACT 200 FIBEROPTIC DELIVERY SYSTEM2Cleared 510(K)
- K913037SHARPLAN SHARPLASE FAMILY ND:YAG SCULPTED FIBERS2Cleared 510(K)
- K912538KTP/YAG PLUS2Cleared 510(K)
- K911457TRIMEDYNE MODEL 1210 OMNIPULSE HOLMIUM LASER SYST2Cleared 510(K)
- K912792SHARPLAN ND:YAG SURG.LASER,MODEL 3040 SHARPLASER2Cleared 510(K)
- K912918IRIS OCULIGHT DIODE LASER ADDING SLIT LAMP ADAPTER2Cleared 510(K)
- K912332MICROSURGE LASER FIBER HOLDER2Cleared 510(K)
- K912284BIOVISION ENDOCULAR PROBE ACCESS DELIV SYST, MODIF2Cleared 510(K)
- K91006202-10,0012Cleared 510(K)
- K911830LASERSCOPE(R) KTP/532 AND KTP/YAG SURGICAL LASER2Cleared 510(K)
- K912029ULTRAPULSE(TM) CARBON DIOXIDE SURGICAL LASER2Cleared 510(K)
- K911987LUXUS 132 ND: YAG SURGICAL LASER SYSTEM2Cleared 510(K)
- K910272HGM COMBINATION ND:YAG & SOLID STATE GREEN2Cleared 510(K)
- K905802CENTAURI/PEGASUS2Cleared 510(K)
- K912438MODELS 5,8,20,20S ARGON ION LASERS2Cleared 510(K)
- K904632CENTAURI YAG LASER SYST, GYNECOLOGY2Cleared 510(K)
- K911150SOREX SAFE-AIR2Cleared 510(K)
- K910602HGM ARGON ION & SOLID LIGHT LASER FOR DENTISTRY2Cleared 510(K)
- K903418LATERALASE TM2Cleared 510(K)
- K895363BIOVISION EMERALD LASER PHOTOCOAGULATOR2Cleared 510(K)
- K904631CENTAURI YAG LASER SYST, NEUROSURGERY2Cleared 510(K)
- K905737CENTAURI/PEGASUS2Cleared 510(K)
- K911852COMPULSE CO2 SURGICAL LASER SYS.2Cleared 510(K)
- K911408CROSSFIRE LASER ASSISTED ASPIRATION CANNULA2Cleared 510(K)
- K910898SURGICA(TM) H2Cleared 510(K)
- K910200LASER-352Cleared 510(K)
- K910496CARBON DIOXIDE LASER SYSTEMS W/ARTHOGUIDE CO2 DEL.2Cleared 510(K)
- K911523MODIFICATION TO MODEL 90-1460 LASER ADAPTER2Cleared 510(K)
- K910894HERAEUS LASERSONIC, INC STERILE DISPOSABLE FIBERS2Cleared 510(K)
- K905676MD CO2 SURGICAL LASER SYSTEM/GEN. SURGERY AND ORTH2Cleared 510(K)
- K904841LPI YAG MODEL 1003 SURGICAL LASER SYST/MODIFIED2Cleared 510(K)
- K904068LUXAR MODEL LX-20 CO2 LASER2Cleared 510(K)
- K910233LASER PHOTONICS ML-210 HOLMIUM:YAG MEDI LASE SYST2Cleared 510(K)
- K910114OPTILITE (TM) FIBEROPTIC DELIVERY SYSTEMS AND ACCE2Cleared 510(K)
- K910137PLP LAPAROSCOPIC CHOLECYSTECTOMY SET2Cleared 510(K)
- K910051SHARPLAN ND:YAG SURG LASER, 3065, SHARPLASER 652Cleared 510(K)
- K904420DISPOSABLE FIBER OPTIC DELIVERY SYSTEM2Cleared 510(K)
- K910726LIGHT-TOUCH AND SURGI LIGHT FIBERS2Cleared 510(K)
- K905708TRIMEDYNE MODEL 1210 OMNIPULSE LASER SYSTEM2Cleared 510(K)
- K904930SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CH2Cleared 510(K)
- K905511CODMAN NEUROLASE LASER SYSTEM/MODIFICATION2Cleared 510(K)
- K903838OPTILASE (TM) MODEL 900 ARGON2Cleared 510(K)
- K905424KTP DISC KIT2Cleared 510(K)
- K905006SURGILASE SL 150 SURGICAL LASER SYSTEM2Cleared 510(K)
- K904700ENDOCOAGULATOR KRS568(TM) LASER2Cleared 510(K)
- K904266AUTODERM SCANNER CONTROL CONSOLE2Cleared 510(K)
- K903131LASERMATIC SUPERCOMBO(TM) SURGICAL LASER SYSTEM2Cleared 510(K)
- K905072ALTAIR2Cleared 510(K)
- K903639NIDEK DC-3000 DIODE LASER PHOTOCOAGULATOR2Cleared 510(K)
- K905082PEGASUS WITH ACCESSORIES2Cleared 510(K)
- K904911DISPOSABLE FIBER OPTIC DELIVERY SYSTEM2Cleared 510(K)
- K905637ILLUMINA MODEL 780 CO2 LASER SYSTEM2Cleared 510(K)
- K905232MOOR LASER BLOOD FLOW MONITOR MBF32Cleared 510(K)
- K905233MOOR LASER BLOOD FLOW MONITOR MBF3D2Cleared 510(K)
- K904628CENTAURI YAG LASER SYST, GASTROENTEROLOGY2Cleared 510(K)
- K904629CENTAURI YAG LASER SYST, UROLOGY2Cleared 510(K)
- K904627CENTAURI YAG LASER SYST, EAR, NOSE , THROAT2Cleared 510(K)
- K904610HERCULES MODEL 5000 AND 5040 ND:YAG LASER SYSTEMS2Cleared 510(K)
- K904354LPI MULILASE YAG/532 SURGICAL LASER SYSTEM2Cleared 510(K)
- K904342SERIES 1990 ARGON SURGICAL LASERS, E1,E6,E14&E20A2Cleared 510(K)
- K904407DISPOSABLE FIBER OPTIC DELIVERY SYST/ND: YAG SURG2Cleared 510(K)
- K904630CENTAURI YAG LASER SYST, OPHTHAMOLOGY2Cleared 510(K)
- K904331L.P.I. LASER DELIVERY SYSTEM2Cleared 510(K)
- K904444MODELS 4000,4900,6000,8000,8900, LUXUS 6&100/17002Cleared 510(K)
- K904423CO2 LASERS AND INFRAGUIDE DELIVERY SYSTEM2Cleared 510(K)
- K904229MULTILASE 602Cleared 510(K)
- K904227MULTILASE 452Cleared 510(K)
- K904402NIDEK INC. MODEL AC-2000 DERM2Cleared 510(K)
- K904203SURGILASE SL 50/60 GOLD SURGICAL LASER SYSTEM2Cleared 510(K)
- K904149FLEXISYS2Cleared 510(K)
- K903154CONTACT FIBERS,SURGICAL PROBES & NON-CONTACT FIBER2Cleared 510(K)
- K904155MEDILAS 4060N FIBERTOM(R) SURGICAL LASER2Cleared 510(K)
- K903943MODEL MC 1100 SURGICAL YAG LASER2Cleared 510(K)
- K904067LASERSAT CO22Cleared 510(K)
- K904126VISIRASER2Cleared 510(K)
- K903936SLT CONTACT LASER SYSTEM ND:YAG MEDICAL LASER SYST2Cleared 510(K)
- K904162CARBON DIOXIDE FLOWTHROUGH LASER MIXTURES2Cleared 510(K)
- K903444MDLS 4000/4900/6000/8000/8900/LUXUS 60/100 ND:YAG2Cleared 510(K)
- K903230SHARPLAN CO2 LASERS, MODEL NUMBERS 1050 AND 10752Cleared 510(K)
- K903079ENDOGUIDE (R), MICROGUIDE (TM), FLEXIGUIDE (TM)2Cleared 510(K)
- K902939OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM2Cleared 510(K)
- K902940CARDIOLASE YAG MODEL 4000 SURGICAL LASER SYSTEM2Cleared 510(K)
- K900858CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES2Cleared 510(K)
- K903027PEGASUS WITH ACCESSORIES2Cleared 510(K)
- K902990COHERENT HOLMIUM:YAG SURGICAL LASER2Cleared 510(K)
- K902946PEGASUS W/ACCESSORIES FOR GENERAL SURGERY2Cleared 510(K)
- K902947PEGASUS W/ACCESSORIES FOR ARTHROSCOPIC APPLICATION2Cleared 510(K)
- K902133MODEL IS102S ND:YAG SURGICAL LASER SYSTEM2Cleared 510(K)
- K902534CENTAURI ERBIUM YITTRIUM ALUMINUM GARNET LASER2Cleared 510(K)
- K902871OPTILITE FIBEROPTIC DELIVERY SYSTEMS2Cleared 510(K)
- K903288IRIS OCULIGHT SL DIODE LASER PHOTOCOAG/MODIFIED2Cleared 510(K)
- K903689COHERENT DIODE PHOTOCOAGULATOR2Cleared 510(K)
- K901710OPTICA 120 ND:YAG SURGICAL LASER SYSTEM2Cleared 510(K)
- K903883VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LES2Cleared 510(K)
- K901127LASERCOMP MODEL STAR 10 FOR KNEE ARTHROSCOPY2Cleared 510(K)
- K900925NIDEK, INC. MODEL ADC-8000 DERM2Cleared 510(K)
- K900890NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA2Cleared 510(K)
- K903849MODEL RD-1200 RUBY LASER SYSTEM2Cleared 510(K)
- K901016LASER-SHIELD II(TM)2Cleared 510(K)
- K901365LASER FORCEPS HANDPIECE2Cleared 510(K)
- K901205MODELS IR103,IR107,IR104,IR205 (ADD'L APPLICATION)2Cleared 510(K)
- K902470COHERENT XA30/SP AND XA50 SURGICAL LASERS2Cleared 510(K)
- K902241SLT CONTACT LASER SYSTEMS (UROLOGY)2Cleared 510(K)
- K900837LPI YAG MODEL 1003 SURGICAL LASER SYSTEM2Cleared 510(K)
- K902148MODELS 4000,4900,6000,8000,8900,LUXUS 60,100,17002Cleared 510(K)
- K902061MODELS 4000,4900,6000,8000,8900,LUXUS 60,100&17002Cleared 510(K)
- K902211SURGILASE YAG 100 SURGICAL LASER SYSTEM2Cleared 510(K)
- K902058ADD'L USE OF THE KTP/YAG SURGICAL LASER2Cleared 510(K)
- K902063NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM2Cleared 510(K)
- K901786LASEGUIDE CAT # CLF-600D & CLF-1000D2Cleared 510(K)
- K901638MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 332Cleared 510(K)
- K901340MODEL MC 2100 ND:YAG SURGICAL LASER SYSTEM2Cleared 510(K)
- K901636DIAMOND ND:YAG OPHTHALMIC LASER2Cleared 510(K)
- K902562REVISED LABELING FOR MODEL CL-0PE ND:YAG LASER2Cleared 510(K)
- K901481MODEL YC-1200/PHOTOCOAGULATOR OPHTHALMIC LASER2Cleared 510(K)
- K894241MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT2Cleared 510(K)
- K901204EXPANDED MARKETING OF MODELS IR104 & IR205 LASERS2Cleared 510(K)
- K901128LASERCOMP MODEL STAR 10 FOR ORAL,GYNECOLOGY SURG.2Cleared 510(K)
- K901943KTP/532 (TM) SURGICAL LASER2Cleared 510(K)
- K896314ENDOSCOPIC USES OF THE ARGON LASER IN GENERAL SURG2Cleared 510(K)
- K900630MODELS 4000/4900/6000/8000/8900, LUXAS&1700 ND:YAG2Cleared 510(K)
- K901008HEXASCAN HANDPIECE2Cleared 510(K)
- K900751HERAEUS LASERSONICS CO2 WAVEGUIDE DELIVERY SYSTEM2Cleared 510(K)
- K900539MODEL DLASE 300 ND:YAG LASER SYSTEM: INTRAORAL2Cleared 510(K)
- K900570SURGILASE YAG 100 IN ORTHOPEDIC SURGERY2Cleared 510(K)
- K900511I.C. MEDICAL ADJUSTABLE DIRECT COUPLER2Cleared 510(K)
- K901211SURGILASE SL50 SURGICAL LASER SYSTEM2Cleared 510(K)
- K901227SURGILASE CO2 SURGICAL LASER SYSTEMS MODEL SL1202Cleared 510(K)
- K900128CL-OPE CONTACT LASER SYSTEM2Cleared 510(K)
- K901541LASER LAPAROSCOPIC CHOLECYSTECTOMY2Cleared 510(K)
- K901021F300 SERIES CONTACT FIBER HANDPIECES2Cleared 510(K)
- K900345SHARPLAN ND:YAG LASERS FOR ENT AND NECK SURGERY2Cleared 510(K)
- K895945KTP/532 SURGICAL LASER SYSTEM W/KTP/YAG MODULE2Cleared 510(K)
- K900253MODEL 20-CH CARBON DIOXIDE LASER W/ADD'L USES2Cleared 510(K)
- K900346SHARPLAN ND:YAG LASER LAPAROSCOPIC CHOLECYSTECTOMY2Cleared 510(K)
- K895347MICRORUPTOR III SYSTEM, CW ND: YAG LASER COMPONENT2Cleared 510(K)
- K900592SHARPLAN MODEL 1055 SEALED CO2 SURGICAL LASER2Cleared 510(K)
- K900166NIDEK, INC. MODELS YC-1100 OPHTHALMIC LASERS2Cleared 510(K)
- K900463LASER DELIVERY SYSTEMS, FIBEROPTICS & CONTACT TIPS2Cleared 510(K)
- K900165NIDEK, INC. BIO-DC LASER DELIVERY SYSTEM2Cleared 510(K)
- K900076SHARPLAN FLEXIBLE CO2 SURGICAL LASER APPLICATOR2Cleared 510(K)
- K900153SHARPLAN ND:YAG DISPOSABLE FIBER DELIVERY SYSTEM2Cleared 510(K)
- K900066FLEXIGUIDE(TM) CO2 LASER HOLLOW FLEXIBLE FIBER2Cleared 510(K)
- K896939DISPOSABLE FIBER OPTIC DELIVERY SYSTEM FOR ND:YAG2Cleared 510(K)
- K900077SHARPLAN 1041 SEALED-OFF CO2 SURGICAL LASER SYSTEM2Cleared 510(K)
- K892912MODEL JM-1 CO2 LASER2Cleared 510(K)
- K897157OPTILASE YAG MODEL 1000 ACV SURGICAL LASER SYSTEM2Cleared 510(K)
- K895656ACCU-BEAM WAVEGUIDE2Cleared 510(K)
- K897099MODEL 2800 ND:YAG OPHTHALMIC LASER2Cleared 510(K)
- K896762SHARPLAN ND:YAG LASER FOR ARTHROSCOPY/MENISCECTOMY2Cleared 510(K)
- K897040LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE (NEURO.)2Cleared 510(K)
- K896838BISTAT ELECTROSURGICAL UNIT 60-5400-0012Cleared 510(K)
- K900144QUARTZ FIBER CATHETERS AND SURGICAL TIPS2Cleared 510(K)
- K896517ILLUMINA MODELS 30, 40 & 55 CO2, MILLIWATT POWER2Cleared 510(K)
- K896478LUXAR MODEL LX-20 MINILASE CO2 LASER2Cleared 510(K)
- K896183KTP/532 SURGICAL LASER FOR PERCUTANEOUS DISKECTOMY2Cleared 510(K)
- K896412GAS MIXTURES AS DEVICE COMPONENTS2Cleared 510(K)
- K896847SHARPLAN 1030 SEALED CO2 SURGICAL LASER SYSTEM2Cleared 510(K)
- K896988NIIC LASER SYSTEM2Cleared 510(K)
- K89604935 WATT SURGICAL CARBON DIOXIDE LASER SYSTEM2Cleared 510(K)
- K896711LISTING PODIATRY AS INTENDED USE FOR ENDOGUIDE2Cleared 510(K)
- K896619LIST DERMATOLOGY/PLASTIC SURGERY AS USE ENDOGUIDE2Cleared 510(K)
- K896617LISTING ENT AS INTENDED USE FOR ENDOGUIDE2Cleared 510(K)
- K896618LIST GENERAL SURGERY AS INTENDED USE FOR ENDOGUIDE2Cleared 510(K)
- K896595LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE2Cleared 510(K)
- K895874OPTILASE YAG MODEL 10002Cleared 510(K)
- K895774GYN-PROBE2Cleared 510(K)
- K895918STERILE DISPOSABLE INFRATIP2Cleared 510(K)
- K895837MEDILASE SYSTEM 2010L LASER LITHOTRIPTOR2Cleared 510(K)
- K895581MODEL: IR205 ARTICULATED SURGICAL LASER2Cleared 510(K)
- K895663SITE 810E PHOTOCOAGULATOR AND ACCESSORIES2Cleared 510(K)
- K895518COHERENT HOLMIUM:YAG SURGICAL LASER2Cleared 510(K)
- K895430HERAEUS LASERSONICS ND:YAG LASER, MODEL LUXUS 1002Cleared 510(K)
- K895247MODEL IR103 SURGICAL LASER SYSTEM2Cleared 510(K)
- K895239MODEL IR107 50-WATT CARBON-DIOXIDE SURGICAL LASER2Cleared 510(K)
- K892359MODEL NUMBER: IR204 CO2 SURGICAL LASER SYSTEM2Cleared 510(K)
- K894471SURGIPROBES AND SURGISCALPES IN HEAD/NECK SURGERY2Cleared 510(K)
- K895279LASERMATIC COMBOLASER MODEL 50502Cleared 510(K)
- K895786ENDOGUIDE PRODUCT LINE: EX0120, EX0300 AND EX04002Cleared 510(K)
- K895299LASERMEDIC 1200 RUBY LASER SYSTEM2Cleared 510(K)
- K895559MODIFIED ENDOGUIDE2Cleared 510(K)
- K895348MICRORUPTOR III SYSTEM, CW ARGON LASER COMPONENT2Cleared 510(K)
- K895263ILLUMINA MODEL 25, 40 AND 55 CO2 LASER SYSTEMS2Cleared 510(K)
- K895029SLT CONTACT LASER SYSTEMS FOR PHOTOCOAGULATION2Cleared 510(K)
- K895073POW-IR TIP2Cleared 510(K)
- K894977OPTILASE YAG MODEL 1000 SURGICAL LASER SYSTEM2Cleared 510(K)
- K894591GYNEGUIDE2Cleared 510(K)
- K895746SHARPLAN MODEL 710 MICROSPOT2Cleared 510(K)
- K894841IRIS OCULIGHT(TM) SL2Cleared 510(K)
- K894709NIDEK MODEL ADC-80002Cleared 510(K)
- K894962CO2 LASER BRONCHOSCOPE COUPLER2Cleared 510(K)
- K895042SHARPLAN CO2 LASERS FOR ARTHROSCOPIC SURGERY2Cleared 510(K)
- K895143COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS2Cleared 510(K)
- K895093SLT CONTACT LASER SYSTEMS2Cleared 510(K)
- K894186SURGIFLEX LASER CONTACT TIPS2Cleared 510(K)
- K894164MODELS 4000,4900,6000,8000,8900 ND YAG 1700ND2Cleared 510(K)
- K894074CO2 SURGICAL LASER SYSTEM2Cleared 510(K)
- K894210SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS2Cleared 510(K)
- K894211SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS2Cleared 510(K)
- K894066SHARPLAN CO2 LAPAROSCOPIC PROBE MODEL 792 TO 792BX2Cleared 510(K)
- K893956EAGLE LASER, SURGICAL, NEODYMIUM DOPED YTTRIUM2Cleared 510(K)
- K893832CO2 LASER SYSTEMS & ARTHROGUIDE CO2 LASER FIBER2Cleared 510(K)
- K894396SURGILASE 25, 40, 45, 55, 60, 80, 100 LASER2Cleared 510(K)
- K894393OPMILAS CO2-L2Cleared 510(K)
- K893642MODIFIED ENDOGUIDE2Cleared 510(K)
- K892933INFRALASE-LASERGUIDE DELIVERY SYSTEM2Cleared 510(K)
- K893701SLT CONTACT LASER SYSTEM2Cleared 510(K)
- K893206SHARPLAN 1075 CO2 LASER2Cleared 510(K)
- K892516CANDELA PLDL-1 PULSED DYE LASER2Cleared 510(K)
- K893529COMBOLASER MODEL 50502Cleared 510(K)
- K885257EAGLE - NEODYUMIUM DOPED YTTRIUM ALUMINUM GARNET2Cleared 510(K)
- K885170LASERCOMP MODEL: 10 STAR 102Cleared 510(K)
- K885060PEGASUS2Cleared 510(K)
- K891909LIGHT-TOUCH/GS 905250 ND:YAG LASER MICRO PRO ENDOS2Cleared 510(K)
- K893013LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE2Cleared 510(K)
- K891130LIGHT-TOUCH LAPAROSCOPIC MODEL 905200 FIBEROPTIC2Cleared 510(K)
- K892211HERAEUS LASERSONIC INC. STERILE DISPOSABLE FIBERS2Cleared 510(K)
- K890922ACCU-BEAM YAG FIBER2Cleared 510(K)
- K892346SLT CONTACT LASER SYSTEMS (GYNECOLOGY)2Cleared 510(K)
- K892345SLT CONTACT LASER SYSTEMS (NEUROSURGERY)2Cleared 510(K)
- K890775INFRALASE - LASERGUIDE DELIVERY SYSTEM2Cleared 510(K)
- K890287SHARPLAN MODEL 1050 SEALED-OFF CO2 SURGICAL LASER2Cleared 510(K)
- K891461SURGILASE YAG 100 SURGICAL ND:YAG LASER/GEN SURG2Cleared 510(K)
- K890322SLT CONTACT LASER SYSTEM (ENT, HEAD & NECK SURG.)2Cleared 510(K)
- K890321SLT CONTACT LASER SYSTEM (ORTHOPEDICS)2Cleared 510(K)
- K890286SHARPLAN MODEL 750 REMOTE CONTROL UNIT (RCU)2Cleared 510(K)
- K890865HEXASCAN SCANNER HANDPIECE2Cleared 510(K)
- K891126MICROLASE CO2 LASER MICROMANIPULATOR2Cleared 510(K)
- K891088MODIFIED LABELING PACKAGING SHARPLAN 2100 STERILE2Cleared 510(K)
- K891016SHARPLAN MODEL 21062Cleared 510(K)
- K890040MODIFIED LABELING & PACKAGING OF SHARPLAN 21002Cleared 510(K)
- K890279MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER2Cleared 510(K)
- K890059SHARPLAN COMBINED CO2/ND:YAG LASER MICRO. #7492Cleared 510(K)
- K885291MODEL 20-CH CARBON DIOXIDE LASER W/ACCESSORIES2Cleared 510(K)
- K890174SLT CLMD CONTACT LASER SYSTEM (ADDIT. INDICATION)2Cleared 510(K)
- K884182SURGILASE YAG 100 SURGIPROBES & SURGISCALPEL2Cleared 510(K)
- K883379MODELS 4000/4900/6000/8000/8900 ND:YAG & 1700 CO22Cleared 510(K)
- K885181(HLI) CARBON DIOXIDE SYSTEMS W/INFRAGUIDE CO22Cleared 510(K)
- K884682LIVING TECHNOLOGY LASER CONTACT TIPS2Cleared 510(K)
- K884459LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE2Cleared 510(K)
- K883488CO2 LASER SYSTEM & ARTHOGUIDE CO2 LASER FIBER DEL.2Cleared 510(K)
- K884994SHARPLAN-MEDILAS 4060N YAG LASER & SERIES 2900 TIP2Cleared 510(K)
- K884456STERILE DISPOSABLE ENDOCULAR PROBE2Cleared 510(K)
- K884431HEXASCAN HANDPIECE FOR ARGON/DYE LASER2Cleared 510(K)
- K884029KTP/532 SURGICAL LASER2Cleared 510(K)
- K883738CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH.2Cleared 510(K)
- K884060MEDITEC QL-15 ND:YAG LASER2Cleared 510(K)
- K883541METALASER VASCULASE2Cleared 510(K)
- K884204COHERENT EXCELITE CO2 AIR FIBER2Cleared 510(K)
- K882952CO2 SURGICAL LASER SYSTEM MODEL #IR1062Cleared 510(K)
- K882951CO2 SURGICAL LASER SYSTEM MODEL #IR1052Cleared 510(K)
- K884311MODEL SL60 SURGILASE CO2 SURGICAL LASER SYSTEMS2Cleared 510(K)
- K884313MODEL SL45 SURGILASE CO2 SURGICAL LASER SYSTEMS2Cleared 510(K)
- K883642CODMAN NEUROLASE LASER SYSTEM2Cleared 510(K)
- K884092SURGILASE CO2 SURGICAL LASER SYSTEM MODEL SL802Cleared 510(K)
- K8830894000/4900/6000/8000/8900 ND:YAG/1700 ND:YAG C022Cleared 510(K)
- K883563SHARPLAN 2100 ND:YAG LASER, SERIES 2900 SYN. TIPS2Cleared 510(K)
- K882926MODEL AU-1 ACCESSORY UNIT2Cleared 510(K)
- K882734KTP/YAG(TM) SURGICAL LASER2Cleared 510(K)
- K882365HERAEUS LASERSONICS ND:YAG LASER, MODEL 49002Cleared 510(K)
- K882738L.P.I. LASER DELIVERY SYSTEM2Cleared 510(K)
- K882772LQ1106 OPHTHALMIC YAG LASER2Cleared 510(K)
- K882942LASER MIXTURE2Cleared 510(K)
- K882212SLT CONTACT LASER SYSTEM2Cleared 510(K)
- K882516THREE-COMPONENT MEDICAL LASER GAS MIXTURES2Cleared 510(K)
- K882208MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES2Cleared 510(K)
- K880816MODEL 130YZ CO2-YAG SURGICAL LASER SYSTEM2Cleared 510(K)
- K881940MODEL 20 KY KRYPTON YELLOW LASER2Cleared 510(K)
- K8816194000/4900/6000/8000/8900 YAG, & 1700 YAG/CO2 LASER2Cleared 510(K)
- K871512SL-100 ND:YAG LASER FOR GYNECOLOGY USE2Cleared 510(K)
- K882243SPTL-1 PULSED DYE LASER2Cleared 510(K)
- K881788KTP/532(TM) SURGICAL LASER2Cleared 510(K)
- K882160COHERENT SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR2Cleared 510(K)
- K882037SHARPLAN MEDILAS 4060 N2Cleared 510(K)
- K880061FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM2Cleared 510(K)
- K881952SHARPLAN MODELS 719-O COLPOSLAD CO2 SU MICROMANI.2Cleared 510(K)
- K881953SHARPLAN MODELS 719/719SR/719SL COLPOSLAD COS SU2Cleared 510(K)
- K881586MODEL MD-45 CO2 LASER FOR ENT APPLICATIONS2Cleared 510(K)
- K881588MODEL MD-25 LASER FOR SURGICAL USE2Cleared 510(K)
- K881587MODEL MD-25 CO2 LASER FOR PODIATRY APPLICATIONS2Cleared 510(K)
- K881585MODEL MD-25 CO2 LASER FOR NEUROSURGERY USE2Cleared 510(K)
- K881584MODEL MD-45 CO2 LASER FOR NEUROSURGERY USE2Cleared 510(K)
- K881583MODEL MD-25 CO2 LASER FOR EAR, NOSE & THROAT2Cleared 510(K)
- K881582MODEL MD-45 CO2 LASER FOR DERMATOLOGY/PODIATRY USE2Cleared 510(K)
- K881581MODEL MD-45 CO2 LASER FOR OB-GYN & UROLOGICAL USE2Cleared 510(K)
- K881580MODEL MD-25 CO2 LASER FOR DERMA./PLASTIC SURGERY2Cleared 510(K)
- K882180MODIFIED SHARPLAN MODEL 1020 CO2 LASER2Cleared 510(K)
- K881870SHARPLAN ND:YAG SURGICAL HAND APPLICATORS2Cleared 510(K)
- K881824LASER MICROMANIPULATOR2Cleared 510(K)
- K881887SHARPLAN 719Y MICROSLAD(TM)2Cleared 510(K)
- K881848MODIFIED MODEL 2100 ND:YAG LASER2Cleared 510(K)
- K880908MODEL PC ARGON LASER2Cleared 510(K)
- K880807ILLUMINA MODEL 25 CO2 LASER FOR GENERAL/PLASTIC SU2Cleared 510(K)
- K880808ILLUMINA MODEL 40 CO2 LASER FOR GENERAL/PLASTIC SU2Cleared 510(K)
- K880809ILLUMINA MODEL 55 CO2 LASER FOR GENERAL/PLASTIC SU2Cleared 510(K)
- K875338CHRYS(TM) MODEL MED-MAX2Cleared 510(K)
- K880603COHERENT XA-40 CO2 SURGICAL LASER2Cleared 510(K)
- K880216MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP.2Cleared 510(K)
- K875115INFRAGUIDE(TM)2Cleared 510(K)
- K874948SUN MEDICAL SMOKE EVACUATOR SYSTEM2Cleared 510(K)
- K874811MODEL 5202 MICROMANIPULATOR2Cleared 510(K)
- K874648COHERENT XA-30/SP CO2 SURGICAL LASER2Cleared 510(K)
- K873790MODELS 4000/6000/8000/8900 LASER FOR DERMA/SURGERY2Cleared 510(K)
- K871933MODEL 5050 SURGILASER FOR NEUROSURGERY USE2Cleared 510(K)
- K873443ULTRASPOT MICROMANIPULATOR2Cleared 510(K)
- K873760SUPERPULSE AMBULASE (XAM-SP) CO2 SURGICAL LASER2Cleared 510(K)
- K873246MODEL 5001 MICROMANIPULATOR FOR USE W/TF-25 CO22Cleared 510(K)
- K873664LIGHT-SPOT FIBEROPTIC LASER HANDPIECE2Cleared 510(K)
- K873571LIGHT-TOUCH FIBEROPTIC MICROCONTACT PROBE2Cleared 510(K)
- K873963COHERENT XA-30 CO2 SURGICAL LASER2Cleared 510(K)
- K873773ENDOCOAGULATOR MODELS 8 AND 20 ARGON LASER2Cleared 510(K)
- K872179CODMAN NEUROLASE LASER SYSTEM2Cleared 510(K)
- K872578MDS-90 ARGON DYE LASER FOR DERMATOLOGY2Cleared 510(K)
- K872711MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY2Cleared 510(K)
- K872589ACCESSORY TO LASER EQUIPMENT - SMOKE EVACUATOR2Cleared 510(K)
- K871619LPM-1 (LASER POWER METER)2Cleared 510(K)
- K871206LUMENX MODEL GAT-577 PHOTOCOAGU. PULSED DYE LASER2Cleared 510(K)
- K871334LASE SYSTEM II2Cleared 510(K)
- K870971MODEL 20-C WITH AN SA-20B/U OPTICAL ATTACHMENT2Cleared 510(K)
- K870970MODEL 10-C WITH AN SA-10B/U OPTICAL ATTACHMENT2Cleared 510(K)
- K870838MODEL 10-C W/ SA-10A/U OPTICAL ATTACHMENT/SURG USE2Cleared 510(K)
- K870837MODEL 20-C W/SA-20A/U OPTICAL ATTACHMENT/SURG USE2Cleared 510(K)
- K870161MODEL 5000 MICROMANIPULATOR MICRO CO2 LASER SYSTEM2Cleared 510(K)
- K8705170.1MM, 0.25MM, 0.5MM, ZOOM DERMATOLOGIC HANDPIECE2Cleared 510(K)
- K864887ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU2Cleared 510(K)
- K864563MODEL LS 840, CO2 LASER2Cleared 510(K)
- K864562MODEL LS 860, CO2 LASER2Cleared 510(K)
- K862514OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG SYS/NEURO2Cleared 510(K)
- K863086SAPPHIRE LASER BLADES (LASER BLADES) ND: YAG2Cleared 510(K)
- K861179CANDELA MODEL SPT-1, PULSED DYE LASER2Cleared 510(K)
- K862815LASER SURGICAL ROD2Cleared 510(K)
- K861044MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND2Cleared 510(K)
- K863183ND:YAG LASER, MODEL 6000 FOR NEUROSURGERY2Cleared 510(K)
- K862863MODEL 10-C W/LC-10A/U FOR OPHTHALMIC & ORBITAL USE2Cleared 510(K)
- K862864MODEL 20-C W/FL-20A/U FOR SURGERY & DERMATOLOGY2Cleared 510(K)
- K862408MODEL 8-B CO2 LASER FOR OPTHALMIC & ORBITAL SURG2Cleared 510(K)
- K861688XANAR CO2 SURGICAL LASER SYSTEM MODEL XAP-152Cleared 510(K)
- K862422MODEL 20-B CO2 LASER FOR GENERAL & PLASTIC SURGERY2Cleared 510(K)
- K860831MODEL LS-870 CO2 SURGICAL LASER SYSTEM (MODIFIED)2Cleared 510(K)
- K862862MODEL 10-C W/FL-10A/U FOR SURGERY AND DERMATOLOGY2Cleared 510(K)
- K863433MODEL 8900 ND:YAG LASER2Cleared 510(K)
- K862423MODEL 8-B CO2 LASER FOR GENERAL & PLASTIC SURGERY2Cleared 510(K)
- K862472QUARTZ RODS TITANIUM RODS2Cleared 510(K)
- K853117COOPER LASER SONICS ND: YAG LASER, MODEL 80082Cleared 510(K)
- K860083DERMASCAN LASER SURGICAL HANDPIECE2Cleared 510(K)
- K860974MODEL 545-45 LASER FOR DERMA., POD., SURGICAL2Cleared 510(K)
- K854468PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC2Cleared 510(K)
- K854473PORTALASE 300 CARBON DIOXIDE SURG LASER NEUROLOGIC2Cleared 510(K)
- K853900ENDO-LASE CD40 FOR NEUROSURGERY2Cleared 510(K)
- K855210SURGICAL CARBON DIOXIDE LASER SYS. #20B ULTRALIGHT2Cleared 510(K)
- K854998SURGICAL CO2 LASER SYSTEM #20/OPTICAL FOR ARTHROSC2Cleared 510(K)
- K853878ENDO-LASE CD-100 CO2 LASER FOR NEUROSURGERY2Cleared 510(K)
- K860087SHARPLAN MODEL 1020 CO2 SURGICAL LASER SYSTEM2Cleared 510(K)
- K860273MODEL 525 - 25 WATT CO2 MEDICAL LASER/PODIATRY2Cleared 510(K)
- K852436AMBULASE2Cleared 510(K)
- K860278MODEL 525-25 WATT CO2 LASER FOR DERMA/PLASTIC2Cleared 510(K)
- K854833MDS-83 IN DERMATOLOGICAL/PLASTIC SURGERY APPLICATI2Cleared 510(K)
- K854386MODEL 20 PREVIOUSLY HAND-HELD CO2 LASER SYSTEM2Cleared 510(K)
- K855246AURORA M MEDICAL DYE LASER2Cleared 510(K)
- K853901ENDO-LASE CD 40 FOR DERMATOLOGY2Cleared 510(K)
- K853877ENDO-LASE CD-100 CO2 LASER FOR DERMATOLOGY2Cleared 510(K)
- K854469PORTALASE 200 CARBON DIOXIDE SURG LASER DERMATOLOG2Cleared 510(K)
- K854472PORTALASE 300 CARBON DIOXIDE SURG LASER DERMATOLOG2Cleared 510(K)
- K854387MODEL 8A PREVIOUSLY MINI HALO CO2 LASER SYSTEM2Cleared 510(K)
- K854398MODEL CO2 LASER SYSTEM 8B2Cleared 510(K)
- K854399MODEL 20-B CO2 LASER SYSTEM2Cleared 510(K)
- K854134FIBEROPTIC COLLIMATING HANDPIECE2Cleared 510(K)
- K853626CODMAN LASER BACKSTOP2Cleared 510(K)
- K853627CODMAN LASER RODS2Cleared 510(K)
- K853620MODEL XA-50 - CO2 SURGICAL LASER2Cleared 510(K)
- K852470SURGILASE 40S2Cleared 510(K)
- K853904ENDO-LASE CD40 FOR UROLOGY2Cleared 510(K)
- K853874ENDO-LASE CD-100 CO2 LASER FOR EXTERNAL GENITALIA-2Cleared 510(K)
- K844178MODEL TT25RF2Cleared 510(K)
- K852860MODEL 920 ARGON/DYE LASER-FOR DERMATOLOGICAL/USE2Cleared 510(K)
- K851405TRIMEDYNE MEDICAL ARGON LASER SYSTEM MODEL 7002Cleared 510(K)
- K853319MINI-HALO(HAND-HELD) CO2 LASER SYSTEM2Cleared 510(K)
- K852696FOR USE IN GENERAL & PLASTIC SURGERY & DERMATOLOGY2Cleared 510(K)
- K852190MODEL 451 CO2 SURGICAL LASER2Cleared 510(K)
- K852122MEDILASER MIC MODEL MEL-445C, 15W2Cleared 510(K)
- K852121MEDILASER MIC MODEL MEL 440-C;30W2Cleared 510(K)
- K850818CO 2 SURGICAL LASER SYSTEM NA-1202Cleared 510(K)
- K850804CO 2 SURGICAL LASER SYSTEM NA-302Cleared 510(K)
- K850805CO 2 SURGICAL LASER SYSTEM MODEL NA-402Cleared 510(K)
- K851000COOPER LASERSONICS 880 CO2/ND:YAG MEDICAL LASER SY2Cleared 510(K)
- K850633SHARPLAN MODEL 1060 CO/2 SURGICAL LASER2Cleared 510(K)
- K850628SHARPLAN 1040 CO/2 SURGICAL LASER2Cleared 510(K)
- K852252870 SURGICAL SYS CONTROL PULSE MODIFICATION2Cleared 510(K)
- K850018LASERSCOPE OMNIPLUS PHOTOSURGICAL SYS ND:YAG2Cleared 510(K)
- K851527UTILIZATION OF ND:YAG LASER FOR TREATMENT RECTAL P2Cleared 510(K)
- K844644SURGICAL LASER MICRO-TIPS2Cleared 510(K)
- K844643S.L.T. LASER DELIVERY HANDLES W/SURGICAL RODS2Cleared 510(K)
- K843915MINI-HALO CO2 LASER SYSTEM2Cleared 510(K)
- K850779MODEL 4000 ND:YAG LASER FOR GENITOURINARY APPLICAT2Cleared 510(K)
- K850985FLEXUS 2 CO2 SURGICAL LASER SYSTEM2Cleared 510(K)
- K841781MODEL 305AA PORTABLE LASER2Cleared 510(K)
- K842703ND-YAG LASER 8000 NEUROSURGERY APPLICA2Cleared 510(K)
- K840739MEDILASER-S MEL-444-S2Cleared 510(K)
- K834166BARD CO2 SURGICAL LASER SYS SLS-50/1002Cleared 510(K)
- K840406MICROSURGICAL CO2 LASER SYS - 41002Cleared 510(K)
- K841234HALO CO LASER SYSTEM2Cleared 510(K)
- K832550SHARPLAN #734 LASER SURGICAL UNIT2Cleared 510(K)
- K832983DERMOLAS2Cleared 510(K)
- K820327MODEL 450XL CO2 SURGICAL LASER2Cleared 510(K)
- K820101SHARPLAN 720 CO2 SURGICAL LASER2Cleared 510(K)
- K801624SHARPLAN 723 CO2 LASER SURGICAL SYSTEM2Cleared 510(K)
- K792418SHARPLAN 743, CO2 LASER SURGICAL SYSTEM2Cleared 510(K)
- K791895ACCESSORIES FOR SYS. 400 CO2 SURG. LASER2Cleared 510(K)
- K782030LASER SYSTEM, SHARPLAN 791/HE, CO22Cleared 510(K)
- K781453MODEL 770 ARGON LASER2Cleared 510(K)
- K780585SURGICAL LASER2Cleared 510(K)
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- KCECannulae, Bronchial1Product Code
- KDCInstrument, Surgical, Disposable1Product Code
- KDDKit, Surgical Instrument, Disposable1Product Code
- KDGChisel (Osteotome)1Product Code
- KFKSaw, Pneumatically Powered1Product Code
- KGLCabinet, Phototherapy (Puva)2Product Code
- KGSRetention Device, Suture1Product Code
- KGWRing (Wound Protector), Drape Retention, Internal2Product Code
- KGYBag, Intestine1Product Code
- KGZAccessories, Catheter1Product Code
- KIKHook, Bone1Product Code
- KOXSolvent, Adhesive Tape1Product Code
- KOYDegreaser, Skin, Surgical1Product Code
- KOZBeads, Hydrophilic, For Wound Exudate Absorption1Product Code
- KQMCamera, Surgical And Accessories1Product Code
- LEJBooth, Sun Tan2Product Code
- LMFAgent, Absorbable Hemostatic, Collagen Based3Product Code
- LMGAgent, Absorbable Hemostatic, Non-Collagen Based3Product Code
- LROGeneral Surgery Tray2Product Code
- LRPTray, Surgical1Product Code
- LRWScissors, General, Surgical1Product Code
- LRYPunch, Surgical1Product Code
- LRZScrewdriver, Surgical1Product Code
- LSAVise, Bench, Surgical1Product Code
- LWGSurgical Table Cushion1Product Code
- LWKRazor, Surgical1Product Code
- LXKScrapper, Skin Specimen1Product Code
- LXZGuard, Instrument1Product Code
- LYVLabel Or Tag, Sterile1Product Code
- LZMGuard, Skin Graft1Product Code
- MCHClip, Hemostatic2Product Code
- MCZSuture Removal Kit1Product Code
- MDAElastomer, Silicone, For Scar Management1Product Code
- MDMInstrument, Manual, Surgical, General Use1Product Code
- MGOClosure, Wound, Adhesive1Product Code
- MIJNeedle, Tumor Localization1Product Code
- MJGDevice, Percutaneous, Biopsy1Product Code
- MKYSystem, Skin Closure1Product Code
- MOQBattery, Replacement, Rechargeable1Product Code
- MPNTissue Adhesive For The Topical Approximation Of Skin2Product Code
- MULGenerator, Electrosurgical, Coagulation, Cancer2Product Code
- MUUSystem, Suction, Lipoplasty2Product Code
- MVRDevice, Anastomotic, Microvascular2Product Code
- MWYSystem, Microwave, Hair Removal2Product Code
- MXGLamp, Uvc, (For Treating Skin And Wounds)2Product Code
- MXWSuture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)2Product Code
- NABGauze / Sponge,Nonresorbable For External Use1Product Code
- NACDressing, Wound, Hydrophilic1Product Code
- NADDressing, Wound, Occlusive1Product Code
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic1Product Code
- NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene2Product Code
- NCAClip, Implantable, For Coronary Artery Bypass Graft (Cabg)2Product Code
- NEHAnchor, Fascial2Product Code
- NEUMarker, Radiographic, Implantable2Product Code
- NEWSuture, Surgical, Absorbable, Polydioxanone2Product Code
- NEYSystem, Ablation, Microwave And Accessories2Product Code
- NJCClip, Vas Deferens2Product Code
- NJUSuture, Nonabsorbable, Nitinol2Product Code
- NJZExtractor, Vein1Product Code
- NLKNeedle, Biopsy, Cardiovascular, Reprocessed1Product Code
- NLLStaple, Implantable, Reprocessed2Product Code
- NMJClip, Implantable, Reprocessed2Product Code
- NMTNeedle, Catheter, Reprocessed1Product Code
- NMUNeedle, Gastro-Urology, Reprocessed1Product Code
- NNABiopsy Device, Percutaneous, Reprocessed1Product Code
- NNCNeedle, Aspiration And Needle, Reprocessed1Product Code
- NRBWound Cleaner, Ultrasound2Product Code
- NRJUltrasound, Skin Permeation2Product Code
- NTBSystem, Ablation, Ultrasound And Accessories2Product Code
- NUJElectrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed2Product Code
- NUVMassager, Vacuum, Light Induced Heating2Product Code
- NVHSuture, Knot, Mechanical2Product Code
- NVJApplicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women2Product Code
- NWFDrill, Battery Powered, Subungual Hematoma1Product Code
- NWJSuture, Recombinant Technology2Product Code
- NXFGas, Laser Generating1Product Code
- NYSWound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)2Product Code
- OABLow Energy Direct Current Thermal Ablation System2Product Code
- ODRElectrosurgical Patient Return Electrode2Product Code
- OEIDrainage Catheter With Antibiotic2Product Code
- OELLaser, Benign Prostatic Hyperplasia2Product Code
- OHOFirst Aid Kit Without Drug1Product Code
- OHSLight Based Over The Counter Wrinkle Reduction2Product Code
- OHTLight Based Over-The-Counter Hair Removal2Product Code
- OHVFocused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption2Product Code
- OJJBurn Kit Without Drug1Product Code
- OJRVacuum Powered Body Fluid Collection Kit2Product Code
- OJTAspiration Tray1Product Code
- OJUSkin Prep Tray1Product Code
- OJVSingle Use Instrument Tray1Product Code
- OUHSkin Resurfacing Rf Applicator2Product Code
- OUPPowered Surgical Instrument For Improvement In The Appearance Of Cellulite2Product Code
- OJWShave Prep Kit2Product Code
- OKJLight Based Treatment For Cold Sores Herpes Simplex Virus-12Product Code
- OKONegative Pressure Wound Therapy Non-Powered Suction Apparatus2Product Code
- OLPOver-The-Counter Powered Light Based Laser For Acne2Product Code
- OMDCutaneous Tissue Adhesive With Mesh2Product Code
- OMPNegative Pressure Wound Therapy Powered Suction Pump2Product Code
- ONEPowered Light Based Non-Laser Surgical Instrument2Product Code
- ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect2Product Code
- ONGPowered Laser Surgical Instrument With Microbeam\Fractional Output2Product Code
- ONQElectrosurgical Coagulation For Aesthetic2Product Code
- OOKDermal Cooling Pack/Vacuum/Massager2Product Code
- ORECryogenic, Skin Tag Removal, Otc2Product Code
- ORKLaser Assisted Lipolysis2Product Code
- OTKWound Drain Catheter System2Product Code
- OUBInstrument For Treatment Of Hyperhidrosis2Product Code
- OVNSuture Kit2Product Code
- OXTPercutaneous Surgical Set With Attachments2Product Code
- OYWLaser, Cellulite Appearance2Product Code
- PAYOver-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction2Product Code
- PBXMassager, Vacuum, Radio Frequency Induced Heat2Product Code
- PBYTemporary Tissue Marker2Product Code
- PDGElectrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.2Product Code
- PDWInternal Tissue Marker2Product Code
- PDZLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis2Product Code
- PFPSilicone Hydrogel For Scar Management1Product Code
- PGZNon-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use2Product Code
- PJKTissue Adhesive For Internal Use3Product Code
- PKDLaceration Tray1Product Code
- PKELaparoscopic Cholecystectomy Kit1Product Code
- PKOTransparent Patch For Use In Treatment Of Tattoos2Product Code
- QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature2Product Code
- PMCScalp Cooling System2Product Code
- PMXAbsorbable Collagen Hemostatic Agent With Thrombin3Product Code
- PNLMagnetic Surgical System2Product Code
- PODTemporary, Internal Use Hemostatic2Product Code
- PQIWound Retraction And Protection System2Product Code
- PSNLight Based Imaging2Product Code
- PTXSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile, Exempt2Product Code
- PUIDrape, Surgical, Exempt2Product Code
- PXNBasic Set-Up Tray1Product Code
- PXOBone Marrow Biopsy Tray1Product Code
- PXPBreast Biopsy / Localization Tray1Product Code
- QRLMultiple Use Blood Lancet For Single Patient Use Only2Product Code
- PXQBurn Dressing Tray1Product Code
- PXRCement And Bone Removal Kit1Product Code
- PXSCholecystectomy Kit1Product Code
- PXUFluid Drainage Tray1Product Code
- PXVGeneral Purpose Instrument Tray1Product Code
- PXWHerniorraphy Kit1Product Code
- PXXIncision Tray1Product Code
- PXYIrrigation Kit (Wounds)1Product Code
- PXZLaparascopic Sphincterotomy Kit1Product Code
- PYALiver Biopsy Kit1Product Code
- PYBMinor Surgical Procedures Tray1Product Code
- PYCParacentesis Tray1Product Code
- PYDPelviscopy Kit1Product Code
- PYEStaple Removal Kit1Product Code
- PYFSterile Puncture Tray1Product Code
- PYGSuction Catheter Kit1Product Code
- PYHSurgical Retractor Kit1Product Code
- PYIThoracic Catheter Insertion Tray1Product Code
- PYJUlcer Wound Tray1Product Code
- PYKVenous Ulcer Kit1Product Code
- PYLWound Drainage Kit1Product Code
- PZLExtracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers2Product Code
- PZQGeneral Laparoscopic Power Morcellation Containment System2Product Code
- QAIPowered Microneedle Device2Product Code
- QAUHemostatic Device For Endoscopic Gastrointestinal Use2Product Code
- QCRWound Autofluorescence Imaging Device2Product Code
- QCYLaser Absorbing Particles2Product Code
- QDFParathyroid Autofluorescence Detection Device2Product Code
- QDGParathyroid Autofluorescence Imaging Device2Product Code
- QRMMultiple Use Blood Lancet For Multiple Patient Use3Product Code
- QFCNegative Pressure Wound Therapy Device For Reduction Of Wound Complications2Product Code
- QHFEnergy Based Device For Treatment Of Tattoos2Product Code
- QJFAutofluorescence Imaging Adjunct Tool For Wounds2Product Code
- QKLLipoaspirate Washing System For Aesthetic Body Contouring2Product Code
- QNMMountable Electromechanical Surgical System For Transluminal Approaches2Product Code
- QPBSystem, Suction, Lipoplasty For Removal2Product Code
- QPXNegative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical2Product Code
- QPZContact Cooling For Skin Lesion Pain Relief2Product Code
- RABSunlamp Products (Pre-Standard)2Product Code
- REFSuntan Bed2Product Code
- REGSuntan Lamp2Product Code
- REHTabletop Sunlamp System2Product Code
- QUBSuction Lipoplasty System For Removal And Transfer2Product Code
- QVJLow Power Electrosurgical Devices For Skin Lesion Destruction2Product Code
- QZNMulti-Photon Imaging2Product Code
- SFGCamera, Surgical, Measurement1Product Code
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Pastelle Pro
- Page Type
- Cleared 510(K)
- 510(k) Number
- K241527
- 510(k) Type
- Traditional
- Applicant
- Wontech Co., Ltd.
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/14/2025
- Days to Decision
- 260 days
- Submission Type
- Summary