ClearanceBrief
Panels › Ophthalmic › Product code HQF · Class 2

Laser, Ophthalmic

Regulation 886.4390

2510(k)s in 12 months (180 all time)
1recalls in 12 months (32 all time)
21recalls that name a 510(k)
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Top companies in HQF

Company510(k)sRecalls
Nidek Co., Ltd.134
Ellex Medical Pty, Ltd.88
Quantel Medical130
Lightmed Corp.101
Iridex Corp80
Carl Zeiss Meditec61
Topcon Medical Laser Systems, Inc.52
Hgm, Inc.60
American Medical Optics50
Bausch & Lomb, Inc.14
Decided510(k)Device and applicantCode
Apr 7, 2026K252979Voyager DSLT (430840610)
Belkin Vision, Ltd., IL
HQF
Feb 6, 2026K251507INTEGRE LIO
Quantel Medical, FR
HQF
Oct 29, 2025K251772Navilas Laser System 577sl (156691)
Od-Os GmbH, DE
HQF
Jun 18, 2025K243014EyeQ nanoECP
Eyeq, Inc.
HQF
Apr 3, 2025K240615Leos Laser and Endoscopy System
Beaver-Visitec International, Inc.
HQF
Oct 25, 2024K242397LYNX Photocoagulator
Norlase Aps, DK
HQF
Sep 6, 2024K233911VISULAS combi
Carl Zeiss Meditec, AG, DE
HQF
Jan 25, 2024K232417MR Q; MR Q SUPINE; MR Q SLT
Meridian AG, CH
HQF
Dec 8, 2023K230722Eagle device
Belkin Vision, Ltd., IL
HQF
Oct 24, 2023K232051VISULAS green
Carl Zeiss Meditec
HQF
Sep 22, 2023K230350VISULAS yag
Carl Zeiss Meditec, Inc.
HQF
Sep 12, 2023K231011Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse
Meridian AG, CH
HQF
Feb 23, 2023K230228Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)
Iridex Corporation
HQF
Dec 27, 2022K220974R:GEN
Lutronic Vision, Inc.
HQF
Nov 9, 2022K223132Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)
Iridex Corporation
HQF
Nov 2, 2022K222395Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo
Ellex Medical Pty, Ltd., AU
HQF
Oct 11, 2022K222157ECHO Photocoagulator
Norlase, DK
HQF
Jul 15, 2022K220877Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems
Lumenis Be, Inc.
HQF
May 12, 2022K220430Capsulo
Quantel Medical, FR
HQF
Mar 23, 2022K213592Iridex 810 Laser
Iridex Corporation
HQF
Dec 16, 2021K212630Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo
Ellex Medical Pty, Ltd., AU
HQF
Dec 7, 2020K203130Ophthalmic Yag Laser System YC-200
Nidek Co., Ltd., JP
HQF
Oct 21, 2020K202760Iridex 810 Laser
Iridex Corporation
HQF
Aug 11, 2020K201623LION Photocoagulator
Norlase Aps, DK
HQF
Aug 6, 2020K201502Vitra 810
Quantel Medical, FR
HQF
Nov 15, 2019K192045Ophthalmic Yag Laser System YC-200
Nidek Co., Ltd., JP
HQF
May 24, 2019K190448LightLas Pattern Scanning System - TruScan Pro
Light-Med(Usa), Inc.
HQF
May 3, 2019K190083Leaf Photocoagulator
Norlase Aps, DK
HQF
Mar 6, 2019K181682VISULAS green
Carl Zeiss Meditec, AG, DE
HQF
May 25, 2018K180402PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar
Topcon Medical Laser Systems, Inc.
HQF
Nov 27, 2017K171488PSLT for PASCAL Streamline
Topcon Medical Laser Systems, Inc.
HQF
Jul 25, 2017K170067Easyret
Quantel Medical, FR
HQF
Jun 23, 2017K170302YELLOW LASER PHOTOCOAGULATOR YLC-500
Nidek Co., Ltd., JP
HQF
Oct 5, 2016K153769R:GEN Laser System
Lutronic Corporation, KR
HQF
Jun 15, 2016K152688LightLas Multi-Wavelength Medical Laser System
Lightmed Corporation, TW
HQF
May 2, 2016K152603Green Laser Photocoagulator GYC-500
Nidek Co., Ltd., JP
HQF
Jul 14, 2015K142398Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow
Ellex Medical Pty, Ltd., AU
HQF
Jun 25, 2015K142830Ophthalmed Bending Laser Probes
Ophthalmed, LLC
HQF
Feb 27, 2015K142172LIGHTMED TRUSCAN 577
Lightmed Corp., TW
HQF
Feb 20, 2015K133019FIBERION OPHTHALMIC ENDOLASER PROBE
Emtron Elektronik VE Mekanik Sanayi VE Ticaret Lim, TR
HQF
Sep 15, 2014K140362KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES
Katalyst Surgical, LLC
HQF
Aug 12, 2014K133358NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT
Nidek Co., Ltd., IT
HQF
Jun 25, 2014K140336OPTIMUS FUSION: SLT, YAG AND YAG/SLT
Quantel Medical
HQF
Nov 1, 2013K130195SCANNING LASERLINK
Lumenis, Inc.
HQF
Oct 9, 2013K131207FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER
Surgical Instrument Engineering AG
HQF
Sep 26, 2013K124043LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM
Lightmed Corp., TW
HQF
Aug 2, 2013K130933SOLUTIS
Quantel Medical
HQF
Jul 1, 2013K122202ELLEX 2RT
Ellex Medical Pty, Ltd., AU
HQF
May 15, 2013K123542PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER
Topcon Medical Laser Systems, Inc.
HQF
Nov 13, 2012K123056PASCAL LASER INDIRECT OPHTHALMOSCOPE
Topcon Medical Laser Systems, Inc. (Tmls)
HQF

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