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
- K253342PICO-K2Cleared 510(K)
- K252877SANDRO Dual2Cleared 510(K)
- K251077JOULE 1064nm System and Accessories2Cleared 510(K)
- K250998CO2 Laser Therapy System (Model: LFS-D9U)2Cleared 510(K)
- K252745Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)2Cleared 510(K)
- K252658Medical Diode Laser Systems (TR-B)2Cleared 510(K)
- K253344BELLUS-Q2Cleared 510(K)
- K253219LeafPure-Echo (LM-LPNdA)2Cleared 510(K)
- K252787Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)2Cleared 510(K)
- K252771Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150)2Cleared 510(K)
- K253123CuRAS hybrid2Cleared 510(K)
- K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)2Cleared 510(K)
- 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)
- K232709Diode laser therapy device2Cleared 510(K)
- K232716Q-Switched Nd:Yag laser2Cleared 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)
- K212734Diode laser therapy device2Cleared 510(K)
- K212733Diode 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)
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- 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)
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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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- K162334U.S. Laser Worx Patriot 1 family of lasers2Cleared 510(K)
- K170936Cutera enlighten III Laser System2Cleared 510(K)
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- K163222Discovery Pico Family2Cleared 510(K)
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- K162191NAVILAS Laser System2Cleared 510(K)
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- K161692Diode Laser Therapy Machine2Cleared 510(K)
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- K162762NeuroBlate System2Cleared 510(K)
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- 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)
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- K161771Medilas H Laser Fibers2Cleared 510(K)
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- 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)
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- K153671Family of CoolGlide Aesthetic Lasers2Cleared 510(K)
- K153527PicoWay Laser System2Cleared 510(K)
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- K151569Tranberg CLS Laser Fiber2Cleared 510(K)
- K152898DIODE LASER THERAPY SYSTEMS2Cleared 510(K)
- K152529NaturaLase CO2 Laser System2Cleared 510(K)
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- K151890Medical Diode Laser Systems2Cleared 510(K)
- K150997RUBY STAR2Cleared 510(K)
- K150664NeoLas2Cleared 510(K)
- K152714Quanta Forte2Cleared 510(K)
- K152636Laser Dock2Cleared 510(K)
- K152153MicroSpot Handpiece2Cleared 510(K)
- K152722neoV980 & neoV1470 Diode Lasers2Cleared 510(K)
- K152012EVO platform2Cleared 510(K)
- K152417Adler MicroMed Laser Surgery Fibers2Cleared 510(K)
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- K152591Medilas H RFID Laser Fibers2Cleared 510(K)
- K151306Solea2Cleared 510(K)
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- K152220MH012Cleared 510(K)
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- K151232VIKINI Diode Laser System2Cleared 510(K)
- K150587Cortex Laser System2Cleared 510(K)
- K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra2Cleared 510(K)
- K151331The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch2Cleared 510(K)
- K150140MCL 31 Dermablate2Cleared 510(K)
- K140386LUMINA 242Cleared 510(K)
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- K142216Tranberg CLS Thermal Therapy System2Cleared 510(K)
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- K150326PicoWay Laser System2Cleared 510(K)
- K150516DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS2Cleared 510(K)
- K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro2Cleared 510(K)
- K150027CYMA2Cleared 510(K)
- K133788COOK HOLMIUM LASER FIBER2Cleared 510(K)
- K143519The MeDioStar NeXT Family2Cleared 510(K)
- K141975WATERLASE IPLUS S2Cleared 510(K)
- K150336Photonica Professional2Cleared 510(K)
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- K143457NeuroBlate System2Cleared 510(K)
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- K141986ELUX 810 LASER2Cleared 510(K)
- K133891MULTIPULSE TM+14702Cleared 510(K)
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- K141555ADVANTAGE2Cleared 510(K)
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- K140470OBERON: LASER SURGERY FIBER, ATRAUMATIC SURGERY FIBER, SIDE FIRE FIBER, RADIAL EMISSION FIBER, DENTAL SURGERY FIBER2Cleared 510(K)
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- K133945CUTERA PICOSECOND LASER SYSTEM2Cleared 510(K)
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- K141403LITHO DK302Cleared 510(K)
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- K140005ALMA DIODE TABLETOP LASER2Cleared 510(K)
- K131757TATTOOSTAR EFFECT COMBO2Cleared 510(K)
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- K133297QUADROSTARPROGREEN, QUADROSTARPROYELLOW2Cleared 510(K)
- K133774ATOVEN2Cleared 510(K)
- K140122CANDELA GENTLEMAX FAMILY OF LASER SYSTEM2Cleared 510(K)
- K131838DIODE LASER FOR HIAR REMOVAL2Cleared 510(K)
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- K133006NEOV DIODE LASER FAMILY2Cleared 510(K)
- K132976ADVATX2Cleared 510(K)
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- K133837VIORA V-TOTAL2Cleared 510(K)
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- K133319ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 10602Cleared 510(K)
- K132975SPHINX JR2Cleared 510(K)
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- K122358NOVEON2Cleared 510(K)
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- K133158ND: YAG LASER SYSTEM2Cleared 510(K)
- K132989SPEED 808 DIODE LASER SYSTEM2Cleared 510(K)
- K132286HYPERION LONG PULSED ND: YAG LASER2Cleared 510(K)
- K131837CO2 FRACTIONAL LASER2Cleared 510(K)
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- K133561VENACURE EVLT NEVERTOUCH PROCEDURE KIT, VENACURE EVLT TRE' SHEATH2Cleared 510(K)
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- K123483DIODE LASER2Cleared 510(K)
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- K102755CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER2Cleared 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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- K100474QUICKLASEDUAL+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 MODEL: 3W,5W,3W,5W2Cleared 510(K)
- K093852EZLASE 3 LASER SYSTEM2Cleared 510(K)
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- K072995TWINWAVE DENTAL LASER, TIDALWAVE 810 DENTAL LASER, TIDALWAVE 980 DENTAL LASER2Cleared 510(K)
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- K072514VISULAS TRION2Cleared 510(K)
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- K071943SERENITY PRO PSF SYSTEM2Cleared 510(K)
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- K061489ATRILAZE MI SURGICAL ABLATION SYSTEM2Cleared 510(K)
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- K063571PALOMAR LUX2940 HANDPIECE2Cleared 510(K)
- K063800CANDELA FLUORESCENT PULSED LIGHT SYSTEM2Cleared 510(K)
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- K070157OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER2Cleared 510(K)
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- K061720COSMELIGHT2Cleared 510(K)
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- K060372INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 32Cleared 510(K)
- K061455DORNIER MEDILAS H 20 LASER2Cleared 510(K)
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- K061366DENLASER 800 PLUS2Cleared 510(K)
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- K061178ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT2Cleared 510(K)
- K060905IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-12Cleared 510(K)
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- K051442PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT2Cleared 510(K)
- K060516ELLIPSE 12PL, MODEL 9ESL72282Cleared 510(K)
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- K060680ATRILAZE SURGICAL ABLATION SYSTEM2Cleared 510(K)
- K060114VECTRA LASER SYSTEM2Cleared 510(K)
- K053628LIGHTSHEER DUET LASER SYSTEM2Cleared 510(K)
- K060326LASERTX - DIODE LASER & DELIVERY SYSTEM2Cleared 510(K)
- K060310FRAXEL II SR LASER SYSTEM AND ACCESSORIES2Cleared 510(K)
- K060301PALOMAR LUX1540 HANDPIECE2Cleared 510(K)
- K060411RADIANCY CLEARTOUCH LITE ACNE CLEARANCE SYSTEM2Cleared 510(K)
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- K060457QUADROSTAR 5322Cleared 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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- K060395CRYO, MODEL V6.02Cleared 510(K)
- K053604WAVELIGHT IDAS2Cleared 510(K)
- K053139FOTONA QX ND:YAG/KTP LASER SYSTEM2Cleared 510(K)
- K053608CYNOSURE PHOTOGENICA V-STAR LASER2Cleared 510(K)
- K042114MDL SERIES DIODE LASERS, MODEL MDL-10/152Cleared 510(K)
- K053421YAG MIR FAMILY LASER2Cleared 510(K)
- K052991RADIANCY FACIAL SKINCARE DEVICE2Cleared 510(K)
- K052442RADIANCY SKINSTATION WITH PSORIASIS LIGHT UNIT ASSEMBLY2Cleared 510(K)
- K060050MEGABEAM SIDEFIBER FIBER OPTIC DELIVERY SYSTEM2Cleared 510(K)
- K052680CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES2Cleared 510(K)
- K053161SIROLASER2Cleared 510(K)
- K053324CHROMOLITE SYSTEM2Cleared 510(K)
- K051113QUANTA SYSTEM ETRNA GIOVINEZZA2Cleared 510(K)
- K052848SPECTRA HAIR REMOVAL LASER2Cleared 510(K)
- K053457VAPORMAX II2Cleared 510(K)
- K052604STARLITE 20062Cleared 510(K)
- K052688ELLIPSE FLEX PPT, MODEL 9ESF72552Cleared 510(K)
- K052874SOPRANO HAIR REMOVAL DIODE LASER2Cleared 510(K)
- K052526NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES2Cleared 510(K)
- K052806BURANE2Cleared 510(K)
- K052495ATRILAZE MALLEABLE ABLATION PROBE2Cleared 510(K)
- K052336SPECTRAQUATTRO PULSED LIGHT SYSTEM2Cleared 510(K)
- K051508MED FLASH II INTENSE PULSED LIGHT SYSTEM.2Cleared 510(K)
- K051259VERSACLEAR SKIN THERAPY SYSTEM, MODEL 1002Cleared 510(K)
- K052324POLARIS LV, LVA APPLICATOR2Cleared 510(K)
- K050382AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM2Cleared 510(K)
- K051876MULTIWAVE XR2Cleared 510(K)
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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)
- K050824100W CERALAS D 980 LASER SYSTEM, MODEL D1002Cleared 510(K)
- K051434COOLTOUCH ND:YAG LASER SYSTEMS, MODELS CT3S AND CTEV2Cleared 510(K)
- K051428VTRAC EXCIMER LAMP SYSTEM2Cleared 510(K)
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- K051287VARI-LASE ENDOVENOUS LASER PROCEDURE KIT2Cleared 510(K)
- K041893INTRALASE FS LASER2Cleared 510(K)
- K043032DEALIGHT IPL2Cleared 510(K)
- K051359CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY2Cleared 510(K)
- K051268RADIANCE ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT2Cleared 510(K)
- K050841FRAXEL SR LASER SYSTEM2Cleared 510(K)
- K051255LUMIPHASE-R2Cleared 510(K)
- K051399WAVELIGHT AURIGA2Cleared 510(K)
- K050779CYNERGY MULTIPLEX LASER2Cleared 510(K)
- K042630REVLIGHT SKIN CARE SYSTEM2Cleared 510(K)
- K050696MEDLITE C1 Q-SWITCHED ND:YAG LASER2Cleared 510(K)
- K050673CANDELA FAMILY OF PULSE DYE LASER SYSTEMS2Cleared 510(K)
- K050738FT FIBER OPTIC DELIVERY SYSTEMS2Cleared 510(K)
- K051167REVOLIX AND REVOLIX JR2Cleared 510(K)
- K043377ZENO2Cleared 510(K)
- K050453ODYSSEY 2.4G, DENLASER ELITE, MODEL 002-000502Cleared 510(K)
- K050900MEDIOSTAR XT2Cleared 510(K)
- K050672ERCHONIA EVRL LASER2Cleared 510(K)
- K050950MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS2Cleared 510(K)
- K050274DIODENT II DENTAL LASER SYSTEM2Cleared 510(K)
- K041554AIP INTENSE PULSED LIGHT SYSTEM2Cleared 510(K)
- K050165MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C1002Cleared 510(K)
- K050254SPECTRA-SP CO2 LASER SYSTEM2Cleared 510(K)
- K050562OCULIGHT GL/GLX2Cleared 510(K)
- K050796AURORA DS, DS APPLICATOR2Cleared 510(K)
- K050679CUTERA SOLERA OPUS AESTHETIC PRODUCT2Cleared 510(K)
- K050047CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY2Cleared 510(K)
- K043521BIOSYAG 50 MED2Cleared 510(K)
- K050293FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS2Cleared 510(K)
- K050021VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT2Cleared 510(K)
- K043329OMNILUX REVIVE AND BLUE2Cleared 510(K)
- K050412VAPORMAX2Cleared 510(K)
- K050108SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS2Cleared 510(K)
- K042319RELIANT LASER II SYSTEM AND ACCESSORIES2Cleared 510(K)
- K050452AURORA SR AND SRA APPLICATOR2Cleared 510(K)
- K043486PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-012Cleared 510(K)
- K050317BURANE XL2Cleared 510(K)
- K043575DERMILLUME, MODEL PRO10002Cleared 510(K)
- K043255ELLIPSE LIGHT SPT2Cleared 510(K)
- K050218WAVELIGHT SINON2Cleared 510(K)
- K043251CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B2Cleared 510(K)
- K043046COOLTOUCH, MODEL CT3S2Cleared 510(K)
- K050069CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT2Cleared 510(K)
- K043173Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES2Cleared 510(K)
- 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)
- K031425GENTLEWAVES LED PHOTOMODULATION DEVICE2Cleared 510(K)
- K042785MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-3002Cleared 510(K)
- K041011ULTRALIGHT II ND:YAG LASER SYSTEM2Cleared 510(K)
- K043164PANALIGHT-BLU, MODEL 41752Cleared 510(K)
- 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)
- K042496ADEPT ULTRALITE 532 LASER2Cleared 510(K)
- K041969AURORA DS2Cleared 510(K)
- K041943XTRAC XL, MODEL AL80002Cleared 510(K)
- K040563LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT)2Cleared 510(K)
- K042439AZURYT MODEL CLT 1401, CO2 SURGICAL LASER SYSTEM2Cleared 510(K)
- K041994MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K041767COOLCUBE COOLPEN2Cleared 510(K)
- K042474ARION2Cleared 510(K)
- K041739EDWARDS E360 SURGICAL ABLATION DEVICE2Cleared 510(K)
- K040921COOLTOUCH, MODEL NS 1602Cleared 510(K)
- K032991LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX2Cleared 510(K)
- K041930VARILITE LASER SYSTEM2Cleared 510(K)
- K042139VISULAS YAG III2Cleared 510(K)
- K041660TRIMEDYNE HOLMIUM LASER SYSTEMS2Cleared 510(K)
- K041829FOCUS MEDICAL NATURALASE LP AND NATURALIGHT FAMILY OF PRODUCTS2Cleared 510(K)
- K041419LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM2Cleared 510(K)
- K041262DURALITE-GL2Cleared 510(K)
- K041721LVI AESTHETIC LASER2Cleared 510(K)
- K041710VERSAWAVE DENTAL ER:YAG LASER SYSTEM2Cleared 510(K)
- K041103ACNELIFT2Cleared 510(K)
- K030290PERIOLASE ND:YAG DENTAL LASER SYSTEM2Cleared 510(K)
- K031140WATERLASE2Cleared 510(K)
- K041569CLEAR100 PHOTOTHERAPY SYSTEM, MODEL FGCM00022Cleared 510(K)
- K040617RELIANT LASER SYSTEM II2Cleared 510(K)
- K040659MCCUE PLC ENERGIST ULTRA VARIABLE PULSED LIGHT SYSTEM2Cleared 510(K)
- K032397DUAL YELLOW LASER, MODEL DUAL YELLOW D10B2Cleared 510(K)
- K041095PHOTOSILK PULSED LIGHT SYSTEM2Cleared 510(K)
- K040433SINON2Cleared 510(K)
- K040384MYDON C2Cleared 510(K)
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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)
- K040156IFL PROFESSIONAL SYSTEM, MODEL C1002Cleared 510(K)
- K032863CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D502Cleared 510(K)
- K032864CERALAS D 810 DIODE LASER SYSTEM, MODEL D152Cleared 510(K)
- K033933POWERLITE 600 EX SYSTEM2Cleared 510(K)
- K033549STARLUX PULSED LIGHT SYSTEM2Cleared 510(K)
- K032459PROFILE 1320 LASER SYSTEM2Cleared 510(K)
- K033251THE FRIENDLYLIGHT ND: YAG LASERS2Cleared 510(K)
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- K033962LAD (EPITURE EASYTOUCH), MODEL LAD-082Cleared 510(K)
- K033354FEMTEC LASER MICROKERATOME2Cleared 510(K)
- K034030APOGEE ELITE2Cleared 510(K)
- K030523WATERLASE2Cleared 510(K)
- K032514AC APPLICATOR, AURORA AC2Cleared 510(K)
- K032667FOCUS MEDICAL 532 HAND PIECE ADAPTER AND DYE PACK ACCESSORIES (RED OR YELLOW)2Cleared 510(K)
- K033176TRISTAR AESTHETIC WORKSTATION LASER2Cleared 510(K)
- K033437SPHINX LASER SYSTEMS2Cleared 510(K)
- K033461CANDELA VBEAM PULSE DYE LASER SYSTEM2Cleared 510(K)
- K033331CANDELA CBEAM PULSE DYE LASER SYSTEM2Cleared 510(K)
- K033423REVOLIX LASER SYSTEMS2Cleared 510(K)
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- K032944YA-MAN LASER 212Cleared 510(K)
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- K032205RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLY2Cleared 510(K)
- K033586MODIFICATION TO AURORA DS2Cleared 510(K)
- K032735SPECTRA QT: Q-SWITCHED ND: YAG LASER SYSTEM2Cleared 510(K)
- K030834CANDELA SMOOTHBEAM LASER SYSTEM2Cleared 510(K)
- K031671POLARIS WR2Cleared 510(K)
- K032383MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM2Cleared 510(K)
- K033237VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER CONSOLE2Cleared 510(K)
- K032260ARAMIS II DERMATOLOGICAL LASER2Cleared 510(K)
- K032539CYNOSURE PHOTOGENICA SV LASER2Cleared 510(K)
- K024206AURA ISURGICAL LASER SYSTEM & ACCESSORIES2Cleared 510(K)
- K032460PROFILE BBL SYSTEM2Cleared 510(K)
- K031795RELIANT LASER SYSTEM2Cleared 510(K)
- K033172CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS2Cleared 510(K)
- K031819DIO-DENT 10 DENTAL DIODE LASER2Cleared 510(K)
- K032599MEDICAL LASER TECHNOLOGIES, LLC MTL ERBIUM:YAG LASER SYSTEM2Cleared 510(K)
- K033181SPR SYSTEM2Cleared 510(K)
- K032704INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-302Cleared 510(K)
- K032703INNOVATECH STRAIGHT LASER PROBE, MODEL 420-102Cleared 510(K)
- K032220ADEPT 1064/532 LASER2Cleared 510(K)
- K032218ADEPT 1064/532/755 LASER2Cleared 510(K)
- K032221ADEPT 1064/755 LASER2Cleared 510(K)
- K032565CYNOSURE PHOTOGENICA VL2Cleared 510(K)
- K030539LASERSMILE2Cleared 510(K)
- K032357NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES2Cleared 510(K)
- K031125CYNOSURE SMART FILE ND:YAG LASERS2Cleared 510(K)
- K032085GREEN LASER PHOTOCOAGULATOR MODEL GYC-10002Cleared 510(K)
- K032805MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT2Cleared 510(K)
- K032023W.O.M. LASER U100PLUS2Cleared 510(K)
- K031440SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER2Cleared 510(K)
- K031389CYNOSURE SMART 2940D ER:YAG LASER2Cleared 510(K)
- K031960INTRALASE FS LASER2Cleared 510(K)
- K030846CANDELA SMOOTHBEAM LASER SYSTEM2Cleared 510(K)
- K031805BLU-U, MODEL 41702Cleared 510(K)
- K031954COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS2Cleared 510(K)
- K032204MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT2Cleared 510(K)
- K032191OMNILIGHT FLUORESCENT PULSED LIGHT SYSTEM2Cleared 510(K)
- K031489PITANGA2Cleared 510(K)
- K031988AURORA DS2Cleared 510(K)
- K031993AURORA SR2Cleared 510(K)
- K031451XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL70002Cleared 510(K)
- K030033LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES2Cleared 510(K)
- K030426OMNILUX RED2Cleared 510(K)
- K030342LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS2Cleared 510(K)
- K031690CYNOSURE YAG FAMILY LASER (PHOTOGENICA YAG AND ACCLAIM)2Cleared 510(K)
- K031258CYNOSURE PHOTOLIGHT PL2Cleared 510(K)
- K024204FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM2Cleared 510(K)
- K031680SPECTRAPULSE2Cleared 510(K)
- K024259PULSED LIGHT THERAPY SYSTEM, MODEL# UV-3002Cleared 510(K)
- K024189NLITE SYSTEM, MODEL#: A00-1025/A00-10332Cleared 510(K)
- K030897SKINSTATION2Cleared 510(K)
- K024093MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS2Cleared 510(K)
- K031233ANDIODYNAMICS, INC. ELVS PROCEDURE KIT2Cleared 510(K)
- K030883OMNILUX BLUE2Cleared 510(K)
- K030654VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT2Cleared 510(K)
- K023881PROFILE 1064 LASER SYSTEM2Cleared 510(K)
- K031488CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASER2Cleared 510(K)
- K030700CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT2Cleared 510(K)
- K031317SMART 2940 D ER: YAG LASER2Cleared 510(K)
- K031184COOL TOUCH 32Cleared 510(K)
- K030805MYTHOS 5002Cleared 510(K)
- K030527LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS2Cleared 510(K)
- K030508DEPILASE TRIO LASE LASER SYSTEM2Cleared 510(K)
- K030510DEPILASE TWIN YAG LASER SYSTEM2Cleared 510(K)
- K030480L600 HAIR REMOVAL2Cleared 510(K)
- K030453COOLTOUCH ND: YAG LASER SYSTEM2Cleared 510(K)
- K031224SMARTXIDE2Cleared 510(K)
- K030506DEPILASE YAG LASE PLUS LASER SYSTEM2Cleared 510(K)
- K030423POWERLITE 600 EP SYSTEM2Cleared 510(K)
- K023734ARAMIS II DERMATOLOGICAL LASER2Cleared 510(K)
- K030959BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-1002Cleared 510(K)
- K030235F1 DIODE LASER SYSTEM2Cleared 510(K)
- K030181INTERNATIONAL BIOPHYSICS CORPORATION (IBC) LASER PEEL SYSTEM2Cleared 510(K)
- K030147LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS2Cleared 510(K)
- K023547DIOLASE 980 D LASER SYSTEM2Cleared 510(K)
- K030186POLRIS LV2Cleared 510(K)
- K024371CANDELA GENTLE LASE FAMILY OF LASER SYSTEM2Cleared 510(K)
- K023257ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX2Cleared 510(K)
- K024260CANDELA GENTLELASE FAMILY OF LASER SYSTEMS2Cleared 510(K)
- K023954ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES2Cleared 510(K)
- K022923CANDELA GENTLE YAG LASER SYSTEM2Cleared 510(K)
- K024335CANDELA GENTLELASE FAMILY OF LASER SYSTEMS2Cleared 510(K)
- K024061PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.002Cleared 510(K)
- K023899DUAL YELLOW LASER, MODEL D10B2Cleared 510(K)
- K022709MEDLITE Q-SWITHCED LASER2Cleared 510(K)
- K030338ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM00022Cleared 510(K)
- K024064POLARIS DS2Cleared 510(K)
- K022807MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA
- K023967PALOMAR Q-YAG ND:YAG LASER SYSTEM2Cleared 510(K)
- K023624SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-69212Cleared 510(K)
- K022951CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG2Cleared 510(K)
- K022341TERABYTE 2000 HAIR REMOVER2Cleared 510(K)
- K022884CANDELA SMOOTHBEAM LASER SYSTEM2Cleared 510(K)
- K023464VIRIDIS TWIN OPHTHALMIC PHOTOCOAGULATOR2Cleared 510(K)
- K021222LAD, MODEL LAD-012Cleared 510(K)
- K024088CERALAS D 980 LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT, MODEL: D15 AND D252Cleared 510(K)
- K022466PROFILE 1320 LASER SYSTEM2Cleared 510(K)
- K023962NEW STAR LASERS, INC. DOVE ND: YAG LASER SYSTEM, MODEL: NS-1602Cleared 510(K)
- K023193CANDELA GENTLE YAG LASER SYSTEM2Cleared 510(K)
- K022607SPECTRAPULSE2Cleared 510(K)
- K023081PROLITE / PLASMALITE MPX PULSED LIGHT SYSTEM (PERMANENT HAIR REDUCTION)2Cleared 510(K)
- K023041W.O.M. LASER U1002Cleared 510(K)
- K021548FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM2Cleared 510(K)
- K023543EVLT KIT AND D15PLUS AND D30PLUS DIODE2Cleared 510(K)
- K022838FOTONA DUALIS ER:YAG/KTP LASER SYSTEM2Cleared 510(K)
- K022839FOTONA DUALIS PLUS ND:YAG LASER SYSTEM2Cleared 510(K)
- K022837FOTONA TANDEM 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)
- K022378PLASMALITE PULSED LIGHT SYSTEM2Cleared 510(K)
- K022381PROFILE 1320 LASER SYSTEM2Cleared 510(K)
- K022351DIODENT DENTAL LASER SYSTEM2Cleared 510(K)
- K022338OPTICAL INTEGRITY GENERAL SHAPED FIBER2Cleared 510(K)
- K022327NOVUS SPECTRA2Cleared 510(K)
- K020839QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, VX, DL2Cleared 510(K)
- 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)
- K003952INDIGO LASEROPTIC TREATMENT SYSTEM2Cleared 510(K)
- K003953INDIGO DIFFUSER-TIP FIBEROPTIC WITH TEMPERATURE SENSING OPTION, MODEL LF0012Cleared 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)
- K991632FOTONA NOVALIS ER: YAG LASER SYSTEM2Cleared 510(K)
- K991634FOTONA NOVALIS R RUBY 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)
- K992083SCATTERFREE LATERAL EMITTING FIBER2Cleared 510(K)
- K992084CYNOSURE SURESCAN WITH THE CO3 ER: YAG LASER2Cleared 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)
- K963996(FSI) LAPAROSCOPIC PROBE FOR ALL FSI ULE FF101 FIBERS. MODEL FSI FF101-LP-XXX, WHERE XXX = FIBER DIAMETERS 100, 200, 4002Cleared 510(K)
- K963991FSI LAPAROSCOPIC PROBE FOR ALL FSI ULE-OVERCLAD FF201 FIBERS2Cleared 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)
- K955014APPLIED OPTRONICS MODEL AOC 25 SURGICAL DIODE2Cleared 510(K)
- K955007APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTEM2Cleared 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)
- K952047LMT 40 AA LASER SURGICAL SYSTEM2Cleared 510(K)
- K952046LMT 20 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)
- K952754SACS, INDEPENDENT FIBER COOLANT SYSTEM2Cleared 510(K)
- K952733SIDEFIRE - TIPPED REUSABLE OPTICAL FIBERS2Cleared 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)
- K944626MODEL 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER2Cleared 510(K)
- K944625MODEL 210-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER2Cleared 510(K)
- K944629MODEL 230-SAC LASER DELIVERY PROBE2Cleared 510(K)
- K944628MODEL 220-SS LASER DELIVERY PROBE2Cleared 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)
- K944624MODEL 130-SAC ASPIRATING ENDOPHOTOCOAGULATOR LASER2Cleared 510(K)
- K944632MODEL 120-SS LASER DELIVERY PROBE2Cleared 510(K)
- K944621MODEL 110-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER2Cleared 510(K)
- K944623MODEL 130-SAS ASPIRATING ENDOPHOTOCOAGULATOR LASER2Cleared 510(K)
- K944622MODEL 110-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER2Cleared 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)
- K943444MEGABEAM LATERAL FIRE2Cleared 510(K)
- K943445MEGABEAM FIBER OPTIC DELIVERY SYSTEM2Cleared 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)
- K920107ADL 800 ND:YAG LASER SYSTEM FOR INTRAORAL TIS. SUR2Cleared 510(K)
- K920106ADL 400 ND;YAG LASER SYSTEM FOR INTRORAL SOFT TIS.2Cleared 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)
- K904627CENTAURI YAG LASER SYST, EAR, NOSE , THROAT2Cleared 510(K)
- K904628CENTAURI YAG LASER SYST, GASTROENTEROLOGY2Cleared 510(K)
- K904629CENTAURI YAG LASER SYST, UROLOGY2Cleared 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)
- K904227MULTILASE 452Cleared 510(K)
- K904229MULTILASE 602Cleared 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)
- K902940CARDIOLASE YAG MODEL 4000 SURGICAL LASER SYSTEM2Cleared 510(K)
- K902939OPTILASE YAG MODEL 1000 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)
- K902947PEGASUS W/ACCESSORIES FOR ARTHROSCOPIC APPLICATION2Cleared 510(K)
- K902946PEGASUS W/ACCESSORIES FOR GENERAL SURGERY2Cleared 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)
- K901227SURGILASE CO2 SURGICAL LASER SYSTEMS MODEL SL1202Cleared 510(K)
- K901211SURGILASE SL50 SURGICAL LASER SYSTEM2Cleared 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)
- K896595LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE2Cleared 510(K)
- K896617LISTING ENT AS INTENDED USE FOR ENDOGUIDE2Cleared 510(K)
- K896618LIST GENERAL SURGERY AS INTENDED USE FOR ENDOGUIDE2Cleared 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)
- K895348MICRORUPTOR III SYSTEM, CW ARGON LASER COMPONENT2Cleared 510(K)
- K895559MODIFIED ENDOGUIDE2Cleared 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)
- K890321SLT CONTACT LASER SYSTEM (ORTHOPEDICS)2Cleared 510(K)
- K890322SLT CONTACT LASER SYSTEM (ENT, HEAD & NECK SURG.)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)
- K884313MODEL SL45 SURGILASE CO2 SURGICAL LASER SYSTEMS2Cleared 510(K)
- K884311MODEL SL60 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)
- K881580MODEL MD-25 CO2 LASER FOR DERMA./PLASTIC SURGERY2Cleared 510(K)
- K881588MODEL MD-25 LASER FOR SURGICAL USE2Cleared 510(K)
- K881587MODEL MD-25 CO2 LASER FOR PODIATRY APPLICATIONS2Cleared 510(K)
- K881586MODEL MD-45 CO2 LASER FOR ENT 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)
- 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)
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- K870970MODEL 10-C WITH AN SA-10B/U OPTICAL ATTACHMENT2Cleared 510(K)
- K870837MODEL 20-C W/SA-20A/U OPTICAL ATTACHMENT/SURG USE2Cleared 510(K)
- K870838MODEL 10-C W/ SA-10A/U OPTICAL ATTACHMENT/SURG USE2Cleared 510(K)
- K870161MODEL 5000 MICROMANIPULATOR MICRO CO2 LASER SYSTEM2Cleared 510(K)
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- K863086SAPPHIRE LASER BLADES (LASER BLADES) ND: YAG2Cleared 510(K)
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- K861044MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL IND2Cleared 510(K)
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- 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)
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- K860831MODEL LS-870 CO2 SURGICAL LASER SYSTEM (MODIFIED)2Cleared 510(K)
- K862862MODEL 10-C W/FL-10A/U FOR SURGERY AND DERMATOLOGY2Cleared 510(K)
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- K860083DERMASCAN LASER SURGICAL HANDPIECE2Cleared 510(K)
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- K854998SURGICAL CO2 LASER SYSTEM #20/OPTICAL FOR ARTHROSC2Cleared 510(K)
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- 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)
- K854399MODEL 20-B CO2 LASER SYSTEM2Cleared 510(K)
- K854387MODEL 8A PREVIOUSLY MINI HALO CO2 LASER SYSTEM2Cleared 510(K)
- K854398MODEL CO2 LASER SYSTEM 8B2Cleared 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)
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- 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)
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- K840739MEDILASER-S MEL-444-S2Cleared 510(K)
- K834166BARD CO2 SURGICAL LASER SYS SLS-50/1002Cleared 510(K)
- K840406MICROSURGICAL CO2 LASER SYS - 41002Cleared 510(K)
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- 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)
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- 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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- HBTApplier, Hemostatic Clip1Product Code
- HCFInstrument, Ligature Passing And Knot Tying1Product Code
- HJELamp, Fluorescein, Ac-Powered2Product Code
- HMPPad, Eye1Product Code
- HRBMicroscope, Operating, Non-Electric, Ophthalmic1Product Code
- HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic1Product Code
- HRQHemostat1Product Code
- HSOSaw1Product Code
- HTCPliers, Surgical1Product Code
- HTDForceps1Product Code
- HTEElevator1Product Code
- HTFCurette1Product Code
- HTRRasp1Product Code
- HTZInstrument, Cutting, Orthopedic1Product Code
- HWMOsteotome1Product Code
- HXDClamp1Product Code
- HXLMallet1Product Code
- HXRSpatula, Orthopedic1Product Code
- HXTTape, Orthopedic1Product Code
- HYAForceps, Wire Holding1Product Code
- JCXApparatus, Suction, Ward Use, Portable, Ac-Powered2Product Code
- JCYCatheter, Infusion1Product Code
- JEATable, Surgical With Orthopedic Accessories, Ac-Powered1Product Code
- JEBTable, Surgical With Orthopedic Accessories, Manual1Product Code
- JOSElectrode, Electrosurgical2Product Code
- JOTElectrode, Gel, Electrosurgical2Product Code
- JYCCannula, Ear1Product Code
- JYDChisel, Mastoid1Product Code
- KAMCannula, Sinus1Product Code
- KANChisel, Nasal1Product Code
- 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
- SGVAgent, Absorbable Hemostatic, Collagen With Polymeric Additives3Product 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
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K250165
- 510(k) Type
- Traditional
- Applicant
- Wontech Co., Ltd.
- Country
- South Korea
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/3/2025
- Days to Decision
- 163 days
- Submission Type
- Summary