FDA Product Code
FDA Product Code HQF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.4390
510(k) Clearances — 180 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252979 | Voyager DSLT (430840610) | Belkin Vision, Ltd. | 2026-04-07 | Traditional | PDF ↗ |
| K251507 | INTEGRE LIO | Quantel Medical | 2026-02-06 | Traditional | PDF ↗ |
| K251772 | Navilas Laser System 577sl (156691) | Od-Os GmbH | 2025-10-29 | Traditional | PDF ↗ |
| K243014 | EyeQ nanoECP | Eyeq, Inc. | 2025-06-18 | Traditional | PDF ↗ |
| K240615 | Leos Laser and Endoscopy System | Beaver-Visitec International, Inc. | 2025-04-03 | Traditional | PDF ↗ |
| K242397 | LYNX Photocoagulator | Norlase Aps | 2024-10-25 | Traditional | PDF ↗ |
| K233911 | VISULAS combi | Carl Zeiss Meditec, AG | 2024-09-06 | Traditional | PDF ↗ |
| K232417 | MR Q; MR Q SUPINE; MR Q SLT | Meridian AG | 2024-01-25 | Traditional | PDF ↗ |
| K230722 | Eagle device | Belkin Vision, Ltd. | 2023-12-08 | Traditional | PDF ↗ |
| K232051 | VISULAS green | Carl Zeiss Meditec | 2023-10-24 | Traditional | PDF ↗ |
| K230350 | VISULAS yag | Carl Zeiss Meditec, Inc. | 2023-09-22 | Traditional | PDF ↗ |
| K231011 | Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse | Meridian AG | 2023-09-12 | Traditional | PDF ↗ |
| K230228 | Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) | Iridex Corporation | 2023-02-23 | Special | PDF ↗ |
| K220974 | R:GEN | Lutronic Vision, Inc. | 2022-12-27 | Traditional | PDF ↗ |
| K223132 | Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) | Iridex Corporation | 2022-11-09 | Special | PDF ↗ |
| K222395 | Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo | Ellex Medical Pty, Ltd. | 2022-11-02 | Traditional | PDF ↗ |
| K222157 | ECHO Photocoagulator | Norlase | 2022-10-11 | Traditional | PDF ↗ |
| K220877 | Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems | Lumenis Be, Inc. | 2022-07-15 | Traditional | PDF ↗ |
| K220430 | Capsulo | Quantel Medical | 2022-05-12 | Traditional | PDF ↗ |
| K213592 | Iridex 810 Laser | Iridex Corporation | 2022-03-23 | Special | PDF ↗ |
| K212630 | Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo | Ellex Medical Pty, Ltd. | 2021-12-16 | Traditional | PDF ↗ |
| K203130 | Ophthalmic Yag Laser System YC-200 | Nidek Co., Ltd. | 2020-12-07 | Traditional | PDF ↗ |
| K202760 | Iridex 810 Laser | Iridex Corporation | 2020-10-21 | Special | PDF ↗ |
| K201623 | LION Photocoagulator | Norlase Aps | 2020-08-11 | Special | PDF ↗ |
| K201502 | Vitra 810 | Quantel Medical | 2020-08-06 | Traditional | PDF ↗ |
| K192045 | Ophthalmic Yag Laser System YC-200 | Nidek Co., Ltd. | 2019-11-15 | Traditional | PDF ↗ |
| K190448 | LightLas Pattern Scanning System - TruScan Pro | Light-Med(Usa), Inc. | 2019-05-24 | Traditional | PDF ↗ |
| K190083 | Leaf Photocoagulator | Norlase Aps | 2019-05-03 | Traditional | PDF ↗ |
| K181682 | VISULAS green | Carl Zeiss Meditec, AG | 2019-03-06 | Traditional | PDF ↗ |
| K180402 | PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar | Topcon Medical Laser Systems, Inc. | 2018-05-25 | Traditional | PDF ↗ |
| K171488 | PSLT for PASCAL Streamline | Topcon Medical Laser Systems, Inc. | 2017-11-27 | Traditional | PDF ↗ |
| K170067 | Easyret | Quantel Medical | 2017-07-25 | Traditional | PDF ↗ |
| K170302 | YELLOW LASER PHOTOCOAGULATOR YLC-500 | Nidek Co., Ltd. | 2017-06-23 | Traditional | PDF ↗ |
| K153769 | R:GEN Laser System | Lutronic Corporation | 2016-10-05 | Traditional | PDF ↗ |
| K152688 | LightLas Multi-Wavelength Medical Laser System | Lightmed Corporation | 2016-06-15 | Traditional | PDF ↗ |
| K152603 | Green Laser Photocoagulator GYC-500 | Nidek Co., Ltd. | 2016-05-02 | Traditional | PDF ↗ |
| K142398 | Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow | Ellex Medical Pty, Ltd. | 2015-07-14 | Traditional | PDF ↗ |
| K142830 | Ophthalmed Bending Laser Probes | Ophthalmed, LLC | 2015-06-25 | Traditional | PDF ↗ |
| K142172 | LIGHTMED TRUSCAN 577 | Lightmed Corp. | 2015-02-27 | Traditional | PDF ↗ |
| K133019 | FIBERION OPHTHALMIC ENDOLASER PROBE | Emtron Elektronik VE Mekanik Sanayi VE Ticaret Lim | 2015-02-20 | Traditional | PDF ↗ |
| K140362 | KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES | Katalyst Surgical, LLC | 2014-09-15 | Traditional | PDF ↗ |
| K133358 | NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT | Nidek Co., Ltd. | 2014-08-12 | Traditional | PDF ↗ |
| K140336 | OPTIMUS FUSION: SLT, YAG AND YAG/SLT | Quantel Medical | 2014-06-25 | Traditional | PDF ↗ |
| K130195 | SCANNING LASERLINK | Lumenis, Inc. | 2013-11-01 | Abbreviated | PDF ↗ |
| K131207 | FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER | Surgical Instrument Engineering AG | 2013-10-09 | Traditional | PDF ↗ |
| K124043 | LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM | Lightmed Corp. | 2013-09-26 | Traditional | PDF ↗ |
| K130933 | SOLUTIS | Quantel Medical | 2013-08-02 | Traditional | PDF ↗ |
| K122202 | ELLEX 2RT | Ellex Medical Pty, Ltd. | 2013-07-01 | Traditional | PDF ↗ |
| K123542 | PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER | Topcon Medical Laser Systems, Inc. | 2013-05-15 | Traditional | PDF ↗ |
| K123056 | PASCAL LASER INDIRECT OPHTHALMOSCOPE | Topcon Medical Laser Systems, Inc. (Tmls) | 2012-11-13 | Special | PDF ↗ |
| K121187 | KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES | Katalyst Surgical, LLC | 2012-09-17 | Traditional | PDF ↗ |
| K120825 | SUPRA SCAN DELIVERY SYSTEM | Quantel Medical | 2012-09-14 | Traditional | PDF ↗ |
| K111460 | OPTO HYALUS GREEN LASER | Opto Eletronica S/A | 2012-08-20 | Traditional | PDF ↗ |
| K112154 | FEMTO LDV | Sie Ag,Surgical Instument Engineering | 2012-03-16 | Traditional | PDF ↗ |
| K111643 | OPTO MITRA YELLOW LASER | Opto Electronica SA | 2011-11-03 | Traditional | PDF ↗ |
| K103547 | LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM | Lightmed Corp. | 2011-11-03 | Traditional | PDF ↗ |
| K111108 | PASCAL STREAMLINE 577 (WITH ACCESSORIES) | Topcon Medical Laser Systems, Inc. | 2011-08-11 | Traditional | PDF ↗ |
| K103056 | VISULAS TRION LASER SYSTEM WITH THE VITE OPTION | Carl Zeiss Meditec, AG | 2011-02-01 | Traditional | PDF ↗ |
| K100253 | VISUMAX LASER KERATOME | Carl Zeiss Meditec, AG | 2010-07-08 | Traditional | PDF ↗ |
| K100019 | PASCAL STREAMLINE PHOTOCOAGULATOR | Optimedica Corporation | 2010-05-04 | Traditional | PDF ↗ |
| K091064 | NAVILAS LASER SYSTEM | Od-Os GmbH | 2009-10-27 | Traditional | PDF ↗ |
| K091981 | LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER | Lightmed Corp. | 2009-09-28 | Traditional | PDF ↗ |
| K092621 | PASCAL STREAMLINE PHOTOCOAGULATOR | Topcon Medical Laser Systems, Inc. | 2009-09-25 | Special | PDF ↗ |
| K091534 | LIGHTLAS MODEL 532 | Lightmed Corp. | 2009-09-18 | Traditional | PDF ↗ |
| K090774 | LIGHTLAS SELECTOR | Lightmed Corp. | 2009-08-13 | Traditional | PDF ↗ |
| K091581 | SUPRA 577.Y LASER | Quantel Medical | 2009-06-16 | Traditional | PDF ↗ |
| K081946 | SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR | Quantel Medical | 2009-03-25 | Special | PDF ↗ |
| K081774 | SOLX 790 TITANIUM SAPPHIRE LASER | Solx, Inc. | 2008-09-12 | Traditional | PDF ↗ |
| K081565 | INTEGRE PRO, MODEL L2RY | Ellex Medical Pty, Ltd. | 2008-07-02 | Special | PDF ↗ |
| K080423 | INTEGRE, MODEL LP581 | Ellex Medical Pty, Ltd. | 2008-03-11 | Special | PDF ↗ |
| K072823 | MERILAS 532A | Meridian AG | 2007-12-14 | Traditional | PDF ↗ |
| K062624 | NEXT GENERATION LASER | Alcon Laboratories | 2007-11-05 | Traditional | PDF ↗ |
| K063297 | LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR | Lightmed Corp. | 2007-09-20 | Traditional | PDF ↗ |
| K070776 | SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR | Quantel Medical | 2007-04-24 | Special | PDF ↗ |
| K062074 | IRIDEX WIRELESS FOOTSWITCH | Iridex Corp | 2006-11-14 | Traditional | PDF ↗ |
| K061024 | PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60 | Peregrine Surgical , Ltd. | 2006-06-21 | Traditional | PDF ↗ |
| K051944 | FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES | Lumenis, Inc. | 2005-09-30 | Traditional | PDF ↗ |
| K050807 | 20G SMA LASER FIBER, MODEL LF100 | Ophthalmed, LLC | 2005-09-21 | Traditional | PDF ↗ |
| K050541 | OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY | Omniguide Communications, Inc. | 2005-05-09 | Traditional | PDF ↗ |
| K043613 | Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II | Quantel Medical | 2005-03-24 | Traditional | PDF ↗ |
| K043236 | FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA | Quantel Medical | 2005-02-07 | Traditional | PDF ↗ |
| K041598 | LASEREX, MODEL LP4532 | Ellex Medical Pty, Ltd. | 2004-10-06 | Traditional | PDF ↗ |
| K040209 | IRIS MEDICAL IQ 810 PHOTOCOAGULATOR | Iridex Corp | 2004-09-20 | Traditional | PDF ↗ |
| K033941 | MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK | Bausch & Lomb, Inc. | 2004-02-10 | Traditional | PDF ↗ |
| K031665 | IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS | Iridex Corp | 2003-08-27 | Traditional | PDF ↗ |
| K031023 | PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10 | Peregrine Surgical , Ltd. | 2003-06-27 | Traditional | PDF ↗ |
| K023094 | IRIDIS OPHTHALMIC PHOTOCOAGULATOR | Quantel Medical | 2002-12-17 | Traditional | PDF ↗ |
| K021538 | LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR | Lightmed Corp. | 2002-08-08 | Traditional | PDF ↗ |
| K020374 | OCULIGHT SL/SLX | Iridex Corp | 2002-05-03 | Traditional | PDF ↗ |
| K013760 | DC-3300 LASER DIODE PHOTOCOAGULATOR | Nidek, Inc. | 2002-02-11 | Traditional | PDF ↗ |
| K010372 | LIGHTLAS 532 PHOTOCOAGULATOR | Lightmed Corp. | 2001-08-22 | Traditional | PDF ↗ |
| K001772 | LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA | Taracan Pty. , Ltd. | 2000-07-06 | Special | PDF ↗ |
| K990665 | BQ/BM INTEGRATED LASER DELIVERY SYSTEM | American Laser Corp. | 1999-05-17 | Traditional | PDF ↗ |
| K990075 | LPULSA SYL-9000 OPHTHALMIC YAG LASER | Light-Med(Usa), Inc. | 1999-03-30 | Traditional | PDF ↗ |
| K981196 | MEDITEC LINK | Aesculap-Meditec North America | 1998-06-17 | Traditional | PDF ↗ |
| K973193 | LUXSCOPE | Luxtec Corp. | 1997-11-21 | Traditional | PDF ↗ |
| K973220 | RODENSTOCK LASER SLITLAMP | G. Rodenstock Instrumente GmbH | 1997-11-04 | Traditional | PDF ↗ |
| K972514 | LASEREX LP1532 PHOTOCOAGULATOR | Ellex Medical Pty, Ltd. | 1997-10-03 | Traditional | PDF ↗ |
| K971950 | INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER | Infinitech, Inc. | 1997-08-01 | Traditional | PDF ↗ |
| K964751 | CERALAS DIODE LASER SYSTEM (CERALAS D2) | Ceram Optec, Inc. | 1997-02-21 | Traditional | PDF ↗ |
Product code HQF · Class II · Ophthalmic. Data: openFDA.