Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Laser, Ophthalmic

FDA product code HQF · 173 cleared devices

Class 2 Ophthalmic

Regulation: 21 CFR 886.4390
Review panel: OP
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1978-12-28 – 2026-04-07

HQF 2026-04-07

Voyager DSLT (430840610)

Applicant Belkin Vision, Ltd.

K number K252979

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HQF 2026-02-06

INTEGRE LIO

Applicant Quantel Medical

K number K251507

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HQF 2025-10-29

Navilas Laser System 577sl (156691)

Applicant Od-Os GmbH

K number K251772

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HQF 2025-06-18

EyeQ nanoECP

Applicant Eyeq, Inc.

K number K243014

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HQF 2025-04-03

Leos Laser and Endoscopy System

Applicant Beaver-Visitec International, Inc.

K number K240615

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HQF 2024-10-25

LYNX Photocoagulator

Applicant Norlase Aps

K number K242397

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HQF 2024-09-06

VISULAS combi

Applicant Carl Zeiss Meditec, AG

K number K233911

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HQF 2024-01-25

MR Q; MR Q SUPINE; MR Q SLT

Applicant Meridian AG

K number K232417

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HQF 2023-12-08

Eagle device

Applicant Belkin Vision, Ltd.

K number K230722

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HQF 2023-10-24

VISULAS green

Applicant Carl Zeiss Meditec

K number K232051

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HQF 2023-09-22

VISULAS yag

Applicant Carl Zeiss Meditec, Inc.

K number K230350

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HQF 2023-09-12

Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse

Applicant Meridian AG

K number K231011

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HQF 2023-02-23

Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)

Applicant Iridex Corporation

K number K230228

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HQF 2022-12-27

R:GEN

Applicant Lutronic Vision, Inc.

K number K220974

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HQF 2022-11-09

Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)

Applicant Iridex Corporation

K number K223132

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HQF 2022-11-02

Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo

Applicant Ellex Medical Pty, Ltd.

K number K222395

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HQF 2022-10-11

ECHO Photocoagulator

Applicant Norlase

K number K222157

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HQF 2022-07-15

Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems

Applicant Lumenis Be, Inc.

K number K220877

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HQF 2022-05-12

Capsulo

Applicant Quantel Medical

K number K220430

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HQF 2022-03-23

Iridex 810 Laser

Applicant Iridex Corporation

K number K213592

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HQF 2021-12-16

Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo

Applicant Ellex Medical Pty, Ltd.

K number K212630

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HQF 2020-12-07

Ophthalmic Yag Laser System YC-200

Applicant Nidek Co., Ltd.

K number K203130

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HQF 2020-10-21

Iridex 810 Laser

Applicant Iridex Corporation

K number K202760

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HQF 2020-08-11

LION Photocoagulator

Applicant Norlase Aps

K number K201623

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HQF 2020-08-06

Vitra 810

Applicant Quantel Medical

K number K201502

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HQF 2019-11-15

Ophthalmic Yag Laser System YC-200

Applicant Nidek Co., Ltd.

K number K192045

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HQF 2019-05-24

LightLas Pattern Scanning System - TruScan Pro

Applicant Light-Med(Usa), Inc.

K number K190448

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HQF 2019-05-03

Leaf Photocoagulator

Applicant Norlase Aps

K number K190083

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HQF 2019-03-06

VISULAS green

Applicant Carl Zeiss Meditec, AG

K number K181682

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HQF 2018-05-25

PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar

Applicant Topcon Medical Laser Systems, Inc.

K number K180402

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HQF 2017-11-27

PSLT for PASCAL Streamline

Applicant Topcon Medical Laser Systems, Inc.

K number K171488

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HQF 2017-07-25

Easyret

Applicant Quantel Medical

K number K170067

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HQF 2017-06-23

YELLOW LASER PHOTOCOAGULATOR YLC-500

Applicant Nidek Co., Ltd.

K number K170302

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HQF 2016-10-05

R:GEN Laser System

Applicant Lutronic Corporation

K number K153769

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HQF 2016-06-15

LightLas Multi-Wavelength Medical Laser System

Applicant Lightmed Corporation

K number K152688

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HQF 2016-05-02

Green Laser Photocoagulator GYC-500

Applicant Nidek Co., Ltd.

K number K152603

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HQF 2013-11-01

SCANNING LASERLINK

Applicant Lumenis, Inc.

K number K130195

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HQF 2013-10-09

FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER

Applicant Surgical Instrument Engineering AG

K number K131207

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HQF 2013-09-26

LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM

Applicant Lightmed Corp.

K number K124043

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HQF 2013-08-02

SOLUTIS

Applicant Quantel Medical

K number K130933

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HQF 2013-07-01

ELLEX 2RT

Applicant Ellex Medical Pty, Ltd.

K number K122202

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HQF 2013-05-15

PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER

Applicant Topcon Medical Laser Systems, Inc.

K number K123542

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HQF 2012-11-13

PASCAL LASER INDIRECT OPHTHALMOSCOPE

Applicant Topcon Medical Laser Systems, Inc. (Tmls)

K number K123056

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HQF 2012-09-17

KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES

Applicant Katalyst Surgical, LLC

K number K121187

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HQF 2012-09-14

SUPRA SCAN DELIVERY SYSTEM

Applicant Quantel Medical

K number K120825

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HQF 2012-08-20

OPTO HYALUS GREEN LASER

Applicant Opto Eletronica S/A

K number K111460

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HQF 2012-03-16

FEMTO LDV

Applicant Sie Ag,Surgical Instument Engineering

K number K112154

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HQF 2011-11-03

OPTO MITRA YELLOW LASER

Applicant Opto Electronica SA

K number K111643

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HQF 2011-11-03

LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM

Applicant Lightmed Corp.

K number K103547

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HQF 2011-08-11

PASCAL STREAMLINE 577 (WITH ACCESSORIES)

Applicant Topcon Medical Laser Systems, Inc.

K number K111108

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HQF 2011-02-01

VISULAS TRION LASER SYSTEM WITH THE VITE OPTION

Applicant Carl Zeiss Meditec, AG

K number K103056

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HQF 2010-07-08

VISUMAX LASER KERATOME

Applicant Carl Zeiss Meditec, AG

K number K100253

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HQF 2010-05-04

PASCAL STREAMLINE PHOTOCOAGULATOR

Applicant Optimedica Corporation

K number K100019

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HQF 2009-10-27

NAVILAS LASER SYSTEM

Applicant Od-Os GmbH

K number K091064

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HQF 2009-09-28

LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER

Applicant Lightmed Corp.

K number K091981

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HQF 2009-09-25

PASCAL STREAMLINE PHOTOCOAGULATOR

Applicant Topcon Medical Laser Systems, Inc.

K number K092621

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HQF 2009-09-18

LIGHTLAS MODEL 532

Applicant Lightmed Corp.

K number K091534

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HQF 2009-08-13

LIGHTLAS SELECTOR

Applicant Lightmed Corp.

K number K090774

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HQF 2009-06-16

SUPRA 577.Y LASER

Applicant Quantel Medical

K number K091581

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HQF 2009-03-25

SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR

Applicant Quantel Medical

K number K081946

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HQF 2008-09-12

SOLX 790 TITANIUM SAPPHIRE LASER

Applicant Solx, Inc.

K number K081774

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HQF 2008-07-02

INTEGRE PRO, MODEL L2RY

Applicant Ellex Medical Pty, Ltd.

K number K081565

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HQF 2008-03-11

INTEGRE, MODEL LP581

Applicant Ellex Medical Pty, Ltd.

K number K080423

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HQF 2007-12-14

MERILAS 532A

Applicant Meridian AG

K number K072823

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HQF 2007-11-05

NEXT GENERATION LASER

Applicant Alcon Laboratories

K number K062624

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HQF 2007-09-20

LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR

Applicant Lightmed Corp.

K number K063297

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HQF 2007-04-24

SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR

Applicant Quantel Medical

K number K070776

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HQF 2006-11-14

IRIDEX WIRELESS FOOTSWITCH

Applicant Iridex Corp

K number K062074

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HQF 2006-06-21

PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60

Applicant Peregrine Surgical , Ltd.

K number K061024

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HQF 2005-09-30

FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES

Applicant Lumenis, Inc.

K number K051944

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HQF 2005-09-21

20G SMA LASER FIBER, MODEL LF100

Applicant Ophthalmed, LLC

K number K050807

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HQF 2005-05-09

OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY

Applicant Omniguide Communications, Inc.

K number K050541

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HQF 2005-03-24

Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II

Applicant Quantel Medical

K number K043613

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HQF 2005-02-07

FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA

Applicant Quantel Medical

K number K043236

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HQF 2004-10-06

LASEREX, MODEL LP4532

Applicant Ellex Medical Pty, Ltd.

K number K041598

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HQF 2004-09-20

IRIS MEDICAL IQ 810 PHOTOCOAGULATOR

Applicant Iridex Corp

K number K040209

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HQF 2004-02-10

MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK

Applicant Bausch & Lomb, Inc.

K number K033941

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HQF 2003-08-27

IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS

Applicant Iridex Corp

K number K031665

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HQF 2003-06-27

PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10

Applicant Peregrine Surgical , Ltd.

K number K031023

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HQF 2002-12-17

IRIDIS OPHTHALMIC PHOTOCOAGULATOR

Applicant Quantel Medical

K number K023094

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HQF 2002-08-08

LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR

Applicant Lightmed Corp.

K number K021538

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HQF 2002-05-03

OCULIGHT SL/SLX

Applicant Iridex Corp

K number K020374

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HQF 2002-02-11

DC-3300 LASER DIODE PHOTOCOAGULATOR

Applicant Nidek, Inc.

K number K013760

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HQF 2001-08-22

LIGHTLAS 532 PHOTOCOAGULATOR

Applicant Lightmed Corp.

K number K010372

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HQF 2000-07-06

LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA

Applicant Taracan Pty. , Ltd.

K number K001772

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HQF 1999-05-17

BQ/BM INTEGRATED LASER DELIVERY SYSTEM

Applicant American Laser Corp.

K number K990665

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HQF 1999-03-30

LPULSA SYL-9000 OPHTHALMIC YAG LASER

Applicant Light-Med(Usa), Inc.

K number K990075

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HQF 1998-06-17

MEDITEC LINK

Applicant Aesculap-Meditec North America

K number K981196

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HQF 1997-11-21

LUXSCOPE

Applicant Luxtec Corp.

K number K973193

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HQF 1997-11-04

RODENSTOCK LASER SLITLAMP

Applicant G. Rodenstock Instrumente GmbH

K number K973220

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HQF 1997-10-03

LASEREX LP1532 PHOTOCOAGULATOR

Applicant Ellex Medical Pty, Ltd.

K number K972514

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HQF 1997-08-01

INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER

Applicant Infinitech, Inc.

K number K971950

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HQF 1997-02-21

CERALAS DIODE LASER SYSTEM (CERALAS D2)

Applicant Ceram Optec, Inc.

K number K964751

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HQF 1996-08-28

OCULIGHT GL

Applicant Iriderm Div.

K number K960971

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HQF 1996-07-19

DIOPEXY PROBE

Applicant Iriderm Div.

K number K960522

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HQF 1995-09-14

NIDEK MODEL GYC-1500 AND GYC-2000

Applicant Nidek, Inc.

K number K951079

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HQF 1995-08-14

VISULINK 900 ARGON

Applicant Carl Zeiss, Inc.

K number K952894

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HQF 1994-11-22

KEELER MULTILASE 3000

Applicant Keeler Instruments, Inc.

K number K942180

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HQF 1994-04-01

MEGABEAM ENDOCULAR PROBE

Applicant Ceram Optec, Inc.

K number K935747

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HQF 1994-03-01

HGM ILLUMINATING IMAGING ENDOCULAR PROBE

Applicant Hgm, Inc.

K number K931784

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