Ophthalmic

HQF · Laser, Ophthalmic

Ophthalmic · 21 CFR 886.4390 · Class 2

Overview

Product CodeHQF
Device NameLaser, Ophthalmic
Regulation21 CFR 886.4390
Device ClassClass 2
Review PanelOphthalmic
3rd-Party ReviewableYes

Identification

An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.

Classification Rationale

Class II.

Cleared Devices (180)

RecordDevice NameApplicantDecision DateDecision
K252979Voyager DSLT (430840610)Belkin Vision, Ltd.Apr 7, 2026SESE
K251507INTEGRE LIOQuantel MedicalFeb 6, 2026SESE
K251772Navilas Laser System 577sl (156691)Od-Os GmbHOct 29, 2025SESE
K243014EyeQ nanoECPEyeq, Inc.Jun 18, 2025SESE
K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc.Apr 3, 2025SESE
K242397LYNX PhotocoagulatorNorlase ApsOct 25, 2024SESE
K233911VISULAS combiCarl Zeiss Meditec, AGSep 6, 2024SESE
K232417MR Q; MR Q SUPINE; MR Q SLTMeridian AGJan 25, 2024SESE
K230722Eagle deviceBelkin Vision, Ltd.Dec 8, 2023SESE
K232051VISULAS greenCarl Zeiss MeditecOct 24, 2023SESE
K230350VISULAS yagCarl Zeiss Meditec, Inc.Sep 22, 2023SESE
K231011Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulseMeridian AGSep 12, 2023SESE
K230228Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)Iridex CorporationFeb 23, 2023SESE
K220974R:GENLutronic Vision, Inc.Dec 27, 2022SESE
K223132Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)Iridex CorporationNov 9, 2022SESE
K222395Tango Neo, Tango Reflex Neo, Ultra Q Reflex NeoEllex Medical Pty, Ltd.Nov 2, 2022SESE
K222157ECHO PhotocoagulatorNorlaseOct 11, 2022SESE
K220877Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser SystemsLumenis Be, Inc.Jul 15, 2022SESE
K220430CapsuloQuantel MedicalMay 12, 2022SESE
K213592Iridex 810 LaserIridex CorporationMar 23, 2022SESE
K212630Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, SoloEllex Medical Pty, Ltd.Dec 16, 2021SESE
K203130Ophthalmic Yag Laser System YC-200Nidek Co., Ltd.Dec 7, 2020SESE
K202760Iridex 810 LaserIridex CorporationOct 21, 2020SESE
K201623LION PhotocoagulatorNorlase ApsAug 11, 2020SESE
K201502Vitra 810Quantel MedicalAug 6, 2020SESE
K192045Ophthalmic Yag Laser System YC-200Nidek Co., Ltd.Nov 15, 2019SESE
K190448LightLas Pattern Scanning System - TruScan ProLight-Med(Usa), Inc.May 24, 2019SESE
K190083Leaf PhotocoagulatorNorlase ApsMay 3, 2019SESE
K181682VISULAS greenCarl Zeiss Meditec, AGMar 6, 2019SESE
K180402PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStarTopcon Medical Laser Systems, Inc.May 25, 2018SESE
K171488PSLT for PASCAL StreamlineTopcon Medical Laser Systems, Inc.Nov 27, 2017SESE
K170067EasyretQuantel MedicalJul 25, 2017SESE
K170302YELLOW LASER PHOTOCOAGULATOR YLC-500Nidek Co., Ltd.Jun 23, 2017SESE
K153769R:GEN Laser SystemLutronic CorporationOct 5, 2016SESE
K152688LightLas Multi-Wavelength Medical Laser SystemLightmed CorporationJun 15, 2016SESE
K152603Green Laser Photocoagulator GYC-500Nidek Co., Ltd.May 2, 2016SESE
K142398Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-YellowEllex Medical Pty, Ltd.Jul 14, 2015SESE
K142830Ophthalmed Bending Laser ProbesOphthalmed, LLCJun 25, 2015SESE
K142172LIGHTMED TRUSCAN 577Lightmed Corp.Feb 27, 2015SESE
K133019FIBERION OPHTHALMIC ENDOLASER PROBEEmtron Elektronik VE Mekanik Sanayi VE Ticaret LimFeb 20, 2015SESE
K140362KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBESKatalyst Surgical, LLCSep 15, 2014SESE
K133358NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNITNidek Co., Ltd.Aug 12, 2014SESE
K140336OPTIMUS FUSION: SLT, YAG AND YAG/SLTQuantel MedicalJun 25, 2014SESE
K130195SCANNING LASERLINKLumenis, Inc.Nov 1, 2013SESE
K131207FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASERSurgical Instrument Engineering AGOct 9, 2013SESE
K124043LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEMLightmed Corp.Sep 26, 2013SESE
K130933SOLUTISQuantel MedicalAug 2, 2013SESE
K122202ELLEX 2RTEllex Medical Pty, Ltd.Jul 1, 2013SESE
K123542PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASERTopcon Medical Laser Systems, Inc.May 15, 2013SESE
K123056PASCAL LASER INDIRECT OPHTHALMOSCOPETopcon Medical Laser Systems, Inc. (Tmls)Nov 13, 2012SESE
K121187KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBESKatalyst Surgical, LLCSep 17, 2012SESE
K120825SUPRA SCAN DELIVERY SYSTEMQuantel MedicalSep 14, 2012SESE
K111460OPTO HYALUS GREEN LASEROpto Eletronica S/AAug 20, 2012SESE
K112154FEMTO LDVSie Ag,Surgical Instument EngineeringMar 16, 2012SESE
K111643OPTO MITRA YELLOW LASEROpto Electronica SANov 3, 2011SESE
K103547LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEMLightmed Corp.Nov 3, 2011SESE
K111108PASCAL STREAMLINE 577 (WITH ACCESSORIES)Topcon Medical Laser Systems, Inc.Aug 11, 2011SESE
K103056VISULAS TRION LASER SYSTEM WITH THE VITE OPTIONCarl Zeiss Meditec, AGFeb 1, 2011SESE
K100253VISUMAX LASER KERATOMECarl Zeiss Meditec, AGJul 8, 2010SESE
K100019PASCAL STREAMLINE PHOTOCOAGULATOROptimedica CorporationMay 4, 2010SESE
K091064NAVILAS LASER SYSTEMOd-Os GmbHOct 27, 2009SESE
K091981LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASERLightmed Corp.Sep 28, 2009SESE
K092621PASCAL STREAMLINE PHOTOCOAGULATORTopcon Medical Laser Systems, Inc.Sep 25, 2009SESE
K091534LIGHTLAS MODEL 532Lightmed Corp.Sep 18, 2009SESE
K090774LIGHTLAS SELECTORLightmed Corp.Aug 13, 2009SESE
K091581SUPRA 577.Y LASERQuantel MedicalJun 16, 2009SESE
K081946SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATORQuantel MedicalMar 25, 2009SESE
K081774SOLX 790 TITANIUM SAPPHIRE LASERSolx, Inc.Sep 12, 2008SESE
K081565INTEGRE PRO, MODEL L2RYEllex Medical Pty, Ltd.Jul 2, 2008SESE
K080423INTEGRE, MODEL LP581Ellex Medical Pty, Ltd.Mar 11, 2008SESE
K072823MERILAS 532AMeridian AGDec 14, 2007SESE
K062624NEXT GENERATION LASERAlcon LaboratoriesNov 5, 2007SESE
K063297LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATORLightmed Corp.Sep 20, 2007SESE
K070776SUPRA OPHTHALMIC LASER PHOTOCOAGULATORQuantel MedicalApr 24, 2007SESE
K062074IRIDEX WIRELESS FOOTSWITCHIridex CorpNov 14, 2006SESE
K061024PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60Peregrine Surgical , Ltd.Jun 21, 2006SESE
K051944FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIESLumenis, Inc.Sep 30, 2005SESE
K05080720G SMA LASER FIBER, MODEL LF100Ophthalmed, LLCSep 21, 2005SESE
K050541OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERYOmniguide Communications, Inc.May 9, 2005SESE
K043613Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS IIQuantel MedicalMar 24, 2005SESE
K043236FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRAQuantel MedicalFeb 7, 2005SESE
K041598LASEREX, MODEL LP4532Ellex Medical Pty, Ltd.Oct 6, 2004SESE
K040209IRIS MEDICAL IQ 810 PHOTOCOAGULATORIridex CorpSep 20, 2004SESE
K033941MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACKBausch & Lomb, Inc.Feb 10, 2004SESE
K031665IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMSIridex CorpAug 27, 2003SESE
K031023PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10Peregrine Surgical , Ltd.Jun 27, 2003SESE
K023094IRIDIS OPHTHALMIC PHOTOCOAGULATORQuantel MedicalDec 17, 2002SESE
K021538LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATORLightmed Corp.Aug 8, 2002SESE
K020374OCULIGHT SL/SLXIridex CorpMay 3, 2002SESE
K013760DC-3300 LASER DIODE PHOTOCOAGULATORNidek, Inc.Feb 11, 2002SESE
K010372LIGHTLAS 532 PHOTOCOAGULATORLightmed Corp.Aug 22, 2001SESE
K001772LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AATaracan Pty. , Ltd.Jul 6, 2000SESE
K990665BQ/BM INTEGRATED LASER DELIVERY SYSTEMAmerican Laser Corp.May 17, 1999SESE
K990075LPULSA SYL-9000 OPHTHALMIC YAG LASERLight-Med(Usa), Inc.Mar 30, 1999SESE
K981196MEDITEC LINKAesculap-Meditec North AmericaJun 17, 1998SESE
K973193LUXSCOPELuxtec Corp.Nov 21, 1997SESE
K973220RODENSTOCK LASER SLITLAMPG. Rodenstock Instrumente GmbHNov 4, 1997SESE
K972514LASEREX LP1532 PHOTOCOAGULATOREllex Medical Pty, Ltd.Oct 3, 1997SESE
K971950INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTERInfinitech, Inc.Aug 1, 1997SESE
K964751CERALAS DIODE LASER SYSTEM (CERALAS D2)Ceram Optec, Inc.Feb 21, 1997SESE
K960971OCULIGHT GLIriderm Div.Aug 28, 1996SESE
K960522DIOPEXY PROBEIriderm Div.Jul 19, 1996SESE
K951079NIDEK MODEL GYC-1500 AND GYC-2000Nidek, Inc.Sep 14, 1995SESE
K952894VISULINK 900 ARGONCarl Zeiss, Inc.Aug 14, 1995SESE
K942180KEELER MULTILASE 3000Keeler Instruments, Inc.Nov 22, 1994SESE
K935747MEGABEAM ENDOCULAR PROBECeram Optec, Inc.Apr 1, 1994SESE
K931784HGM ILLUMINATING IMAGING ENDOCULAR PROBEHgm, Inc.Mar 1, 1994SESE
K932836NIDEK MODEL AC-2300Nidek, Inc.Nov 22, 1993SESE
K932296JR -- OPHTHALMIC ARGON LASERCarson LaserworksNov 12, 1993SESE
K925663HGM ASPIRATING ENDOOCULAR(TM) PROBEHgm, Inc.Aug 17, 1993SESE
K926470LASER AND EMPHASIS SCLEROSTOMY TIPSummit Technology, Inc.Jul 22, 1993SESE
K910532URAM OPHTHALMIC LASER ENDOSCOPEMartin S. Knopf Assoc., Inc.May 28, 1991SESE
K910805ND:YAG LASER SYSTEMS (VARIOUS MODELS)Heraeus Lasersonics, Inc.May 24, 1991SESE
K904699COMPAC(TM) DIODE LASERSHgm Medical Laser Systems, Inc.Apr 25, 1991SESE
K905453CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HANDDouglas James Donaldson Compliance ServicesMar 5, 1991SESE
K910612CANDELA DIODE TRABECULOPLASTY LASER DTLCandela Laser Corp.Mar 4, 1991SESE
K905141CENTAURIPfizer Laser SystemsFeb 11, 1991SESE
K903421TOPCON EC-200 ENDO-PHOTOCOAGULATOR LASERTop ConDec 18, 1990SESE
K904366CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATORDouglas James Donaldson Compliance ServicesOct 19, 1990SESE
K900199LASAG MICRORUPTER 2 ND:YAG LASER TRABECULOPLASTYLasag AGMar 27, 1990SESE
K895213MICROLASE BY LASER TRABECULOPLASTYKeeler Instruments, Inc.Oct 31, 1989SESE
K895196MODEL DC-1200 DIODE LASER PHOTOCOAGULATORNidek, Inc.Oct 16, 1989SESE
K894835LASERMED* GOGGLES AND SPECTACLESGlendale Protective Technologies, Inc.Sep 21, 1989SESE
K894273NIDEK MODEL AKC-8000Nidek, Inc.Aug 7, 1989SESE
K893630CANDELA UPC LASER PHOTOCOAGULATORCandela Laser Corp.Aug 2, 1989SESE
K893709COHERENT MARIE ARGON PHOTOCOAGULATORCoherent Medical GroupJun 15, 1989SESE
K890509INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEMBiophysic Medical, Inc.Mar 24, 1989SESE
K890086MICROLASE 8 0 0 (OPHTHALMIC LASER)Keeler Instruments, Inc.Mar 15, 1989SESE
K885164LASAG MICRORUPTOR 2 ND:YAG OPHTH. LASER SYSTEMChiron Vision Corp.Jan 10, 1989SESE
K882908SLT CL60 CONTACT LASER SYSTEM, CUTTING & COAGULA.Surgical Laser Technologies, Inc.Sep 30, 1988SESE
K883213NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS)Nidek, Inc.Sep 15, 1988SESE
K881494FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASERBiophysic Medical, Inc.Aug 30, 1988SN
K882372RESUBMITTED DIODE LASER COAGULATORCooperVision, Inc.Aug 2, 1988SESE
K881134SLT CONTACT LASER SYSTEM OCULOPLASTICSSurgical Laser Technologies, Inc.Jun 6, 1988SESE
K875000PRISMA DISPOSABLE ENDO-OCULAR PROBEAdvanced Surgical Products, Inc.Apr 13, 1988SESE
K874609ZEISS VISULAS ARGON LASERCarl Zeiss, Inc.Jan 6, 1988SESE
K873460OPHTHALAS DYE OPHTHALMIC LASERBiophysic Medical, Inc.Oct 29, 1987SESE
K872846NIDEK ADC-8000 LASER SYSTEMNidek, Inc.Oct 15, 1987SESE
K870839MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMICDirected Energy, Inc.May 22, 1987SESE
K864063ORION 3001, LASER PHOTOCOAGULATORG. Rodenstock Instrumente GmbHNov 13, 1986SESE
K863246MIRALITEMira, Inc.Oct 31, 1986SESE
K863591ENDOPHOTOCOAGULATION PROBEMira, Inc.Oct 10, 1986SESE
K862568LDS - LASER DELIVERY SYSTEMCoherent Medical GroupOct 7, 1986SESE
K862987MODEL 1000 OPHTHALMIC LASER SYSTEMCooperVision, Inc.Sep 24, 1986SESE
K860358FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE (STERILE)Hgm, Inc.Mar 21, 1986SESE
K854949MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYSCooperVision, Inc.Feb 4, 1986SESE
K854288OPHALMIC LASER PHOTOCOAGULATORMira, Inc.Nov 12, 1985SESE
K853890OPHTHALMIC LASER PHOTOCOAGULATORMira, Inc.Nov 12, 1985SESE
K852529HESSBURG GLIDE UNTRAOCULAR LENS GUIDESVisitec Co.Sep 24, 1985SESE
K852234MDS 83 OPHTHALMIC DYE LASER SYSTEMMeditec, Inc.Aug 1, 1985SESE
K852464HCG, INC. MEDICAL LASER ENDOCOAGULATOR MODEL P.C.Hcg, Inc.Jul 25, 1985SESE
K844357SYSTEM 920 ARGON/DYE PHOTOCOAGULATORCoherent Medical GroupJun 5, 1985SESE
K850572HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-KHgm, Inc.Apr 23, 1985SESE
K844668MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LECooper Lasersonics, Inc.Jan 3, 1985SESE
K844358SYSTEM 920 PHOTOCOAGULATOR TO INCLUDE SCHIRMERSCOPCoherent Medical GroupJan 3, 1985SESE
K843965ARGON LASER PHOTOCOAGULATOR SYSAmerican Medical OpticsNov 6, 1984SESE
K842251AMERI. MEDICAL OPTICS ARGON LASER PHOTOAmerican Medical OpticsAug 15, 1984SESE
K842250AMER. MEDICAL OPTICS ARGON/KRYPTON LASEAmerican Medical OpticsAug 15, 1984SESE
K842412MODEL 4000 MD-YAG LASER FOR MALIGNANTCooper Lasersonics, Inc.Jun 26, 1984SESE
K841855AMER. MED. OPTICS ARGON LASER PHOTOAmerican Medical OpticsJun 19, 1984SESE
K841856AMER. MED. OPTICS ARGON/KRYPTON LASERAmerican Medical OpticsJun 7, 1984SESE
K840590FLEISCHMAN-SWARTZ ENDO-OCULAR PROBEHgm, Inc.May 9, 1984SESE
K840145MONITOR CO2 LASER SURGICAL SYSTEMCooper Lasersonics, Inc.Apr 25, 1984SESE
K834610LASER LENS-VARIOUS MODELSMeditec of AmericaApr 5, 1984SESE
K840854MEDICAL LASER ENDOCOAGULATOR 5KHgm, Inc.Apr 2, 1984SESE
K834305ARGON/KRYPTON ION LASER PHOTOCOAGULANidek, Inc.Mar 16, 1984SESE
K834060RELIANCE OPHTHALMIC SLIT LAMP R-083F. & F. KoenigkramerFeb 4, 1984SESE
K833532OCULASE 514 OPHTHALMIC ARGON LASERLasermed Corp.Feb 4, 1984SESE
K833533LASER PHOTOCOAGULATOR 1520-A & KBritt Corp., Inc.Jan 30, 1984SESE
K832316OPHTHALMIC ARGON LASER #700ALaser Industries , Ltd.Jan 30, 1984SESE
K832089MODEL 150K LASER COAGULATORLasertek OYJan 30, 1984SESE
K833232LASER PROTECTIVE EYESHIELDStefanovsky & Assoc.Dec 30, 1983SESE
K833274DERMATOLOGY HANDPIECE-OPHTH LASERSynemed, Inc.Dec 3, 1983SESE
K813492BRITT KRYPTON LASERS 150K & 152KBritt Corp., Inc.Jan 22, 1982SESE
K812219MODEL 900S INTRAOCULAR PROBELumenis, Inc.Nov 16, 1981SESE
K801336MODEL 900K PHOTOCOAGULATORCoherent Medical DivisionJul 28, 1980SESE
K791659MEDITEC (RODENSTOCK) LASER PHOTOCOAGULCoburn Optical Ind., Inc.Oct 11, 1979SESE
K782106COAGULATOR, MODEL 40 AARGONLasertek OYFeb 8, 1979SESE
K781965LASER COAGULATOR, MODEL 41AKLasertek OYFeb 8, 1979SESE
K782065LASER, PHOTOCOAGULATIONCavitron Corp.Dec 28, 1978SESE

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