FDA 510(k) Applications for Medical Device Product Code "HQF"
(Laser, Ophthalmic)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K981196 | AESCULAP-MEDITEC NORTH AMERICA | MEDITEC LINK | 06/17/1998 |
| K062624 | ALCON LABORATORIES | NEXT GENERATION LASER | 11/05/2007 |
| K990665 | AMERICAN LASER CORP. | BQ/BM INTEGRATED LASER DELIVERY SYSTEM | 05/17/1999 |
| K033941 | BAUSCH & LOMB, INC. | MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK | 02/10/2004 |
| K240615 | Beaver-Visitec International, Inc. | Leos Laser and Endoscopy System | 04/03/2025 |
| K230722 | BELKIN Vision Ltd. | Eagle device | 12/08/2023 |
| K232051 | Carl Zeiss Meditec | VISULAS green | 10/24/2023 |
| K233911 | Carl Zeiss Meditec AG | VISULAS combi | 09/06/2024 |
| K181682 | Carl Zeiss Meditec AG | VISULAS green | 03/06/2019 |
| K103056 | CARL ZEISS MEDITEC AG | VISULAS TRION LASER SYSTEM WITH THE VITE OPTION | 02/01/2011 |
| K100253 | CARL ZEISS MEDITEC AG | VISUMAX LASER KERATOME | 07/08/2010 |
| K230350 | Carl Zeiss Meditec Inc | VISULAS yag | 09/22/2023 |
| K964751 | CERAMOPTEC, INC. | CERALAS DIODE LASER SYSTEM (CERALAS D2) | 02/21/1997 |
| K222395 | Ellex Medical Pty Ltd | Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo | 11/02/2022 |
| K212630 | Ellex Medical Pty Ltd | Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo | 12/16/2021 |
| K122202 | Ellex Medical Pty. Ltd. | ELLEX 2RT | 07/01/2013 |
| K142398 | Ellex Medical Pty. Ltd. | Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow | 07/14/2015 |
| K081565 | Ellex Medical Pty. Ltd. | INTEGRE PRO, MODEL L2RY | 07/02/2008 |
| K080423 | Ellex Medical Pty. Ltd. | INTEGRE, MODEL LP581 | 03/11/2008 |
| K972514 | Ellex Medical Pty. Ltd. | LASEREX LP1532 PHOTOCOAGULATOR | 10/03/1997 |
| K041598 | Ellex Medical Pty. Ltd. | LASEREX, MODEL LP4532 | 10/06/2004 |
| K133019 | EMTRON ELEKTRONIK VE MEKANIK SANAYI VE TICARET LIM | FIBERION OPHTHALMIC ENDOLASER PROBE | 02/20/2015 |
| K243014 | EyeQ Inc. | EyeQ nanoECP | 06/18/2025 |
| K973220 | G. RODENSTOCK INSTRUMENTE GMBH | RODENSTOCK LASER SLITLAMP | 11/04/1997 |
| K971950 | INFINITECH, INC. | INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER | 08/01/1997 |
| K960522 | IRIDERM DIV. | DIOPEXY PROBE | 07/19/1996 |
| K960971 | IRIDERM DIV. | OCULIGHT GL | 08/28/1996 |
| K062074 | IRIDEX CORP. | IRIDEX WIRELESS FOOTSWITCH | 11/14/2006 |
| K040209 | IRIDEX CORP. | IRIS MEDICAL IQ 810 PHOTOCOAGULATOR | 09/20/2004 |
| K031665 | IRIDEX CORP. | IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS | 08/27/2003 |
| K020374 | IRIDEX CORP. | OCULIGHT SL/SLX | 05/03/2002 |
| K230228 | Iridex Corporation | Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) | 02/23/2023 |
| K202760 | Iridex Corporation | Iridex 810 Laser | 10/21/2020 |
| K213592 | Iridex Corporation | Iridex 810 Laser | 03/23/2022 |
| K223132 | Iridex Corporation | Iridex PASCAL« 532, Iridex PASCAL« 577, Iridex PASCAL« (532nm and 577 nm models) | 11/09/2022 |
| K121187 | KATALYST SURGICAL, LLC | KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES | 09/17/2012 |
| K140362 | KATALYST SURGICAL, LLC | KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES | 09/15/2014 |
| K990075 | LIGHT-MED (USA), INC. | LPULSA SYL-9000 OPHTHALMIC YAG LASER | 03/30/1999 |
| K190448 | Light-Med(USA), INC. | LightLas Pattern Scanning System - TruScan Pro | 05/24/2019 |
| K010372 | LIGHTMED CORP. | LIGHTLAS 532 PHOTOCOAGULATOR | 08/22/2001 |
| K063297 | LIGHTMED CORP. | LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR | 09/20/2007 |
| K091981 | LIGHTMED CORP. | LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER | 09/28/2009 |
| K021538 | LIGHTMED CORP. | LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR | 08/08/2002 |
| K124043 | LIGHTMED CORP. | LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM | 09/26/2013 |
| K091534 | LIGHTMED CORP. | LIGHTLAS MODEL 532 | 09/18/2009 |
| K103547 | LIGHTMED CORP. | LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM | 11/03/2011 |
| K090774 | LIGHTMED CORP. | LIGHTLAS SELECTOR | 08/13/2009 |
| K142172 | LIGHTMED CORP. | LIGHTMED TRUSCAN 577 | 02/27/2015 |
| K152688 | LIGHTMED CORPORATION | LightLas Multi-Wavelength Medical Laser System | 06/15/2016 |
| K220877 | Lumenis Be, Inc. | Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems | 07/15/2022 |
| K051944 | LUMENIS, INC. | FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES | 09/30/2005 |
| K130195 | LUMENIS, INC. | SCANNING LASERLINK | 11/01/2013 |
| K153769 | Lutronic Corporation | R:GEN Laser System | 10/05/2016 |
| K220974 | Lutronic Vision, Inc. | R:GEN | 12/27/2022 |
| K973193 | LUXTEC CORP. | LUXSCOPE | 11/21/1997 |
| K231011 | Meridian AG | Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse | 09/12/2023 |
| K072823 | MERIDIAN AG | MERILAS 532A | 12/14/2007 |
| K232417 | Meridian AG | MR Q; MR Q SUPINE; MR Q SLT | 01/25/2024 |
| K133358 | NIDEK CO., LTD | NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT | 08/12/2014 |
| K152603 | NIDEK CO., LTD. | Green Laser Photocoagulator GYC-500 | 05/02/2016 |
| K203130 | Nidek Co., Ltd. | Ophthalmic Yag Laser System YC-200 | 12/07/2020 |
| K192045 | Nidek Co., Ltd. | Ophthalmic Yag Laser System YC-200 | 11/15/2019 |
| K170302 | NIDEK CO., LTD. | YELLOW LASER PHOTOCOAGULATOR YLC-500 | 06/23/2017 |
| K013760 | NIDEK, INC. | DC-3300 LASER DIODE PHOTOCOAGULATOR | 02/11/2002 |
| K222157 | Norlase | ECHO Photocoagulator | 10/11/2022 |
| K190083 | Norlase ApS | Leaf Photocoagulator | 05/03/2019 |
| K201623 | Norlase ApS | LION Photocoagulator | 08/11/2020 |
| K242397 | Norlase Aps | LYNX Photocoagulator | 10/25/2024 |
| K091064 | OD -OS GMBH | NAVILAS LASER SYSTEM | 10/27/2009 |
| K050541 | OMNIGUIDE COMMUNICATIONS, INC. | OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY | 05/09/2005 |
| K050807 | OPHTHALMED LLC | 20G SMA LASER FIBER, MODEL LF100 | 09/21/2005 |
| K142830 | OPHTHALMED LLC | Ophthalmed Bending Laser Probes | 06/25/2015 |
| K100019 | OPTIMEDICA CORPORATION | PASCAL STREAMLINE PHOTOCOAGULATOR | 05/04/2010 |
| K111643 | OPTO ELECTRONICA SA | OPTO MITRA YELLOW LASER | 11/03/2011 |
| K111460 | OPTO ELETRONICA S/A | OPTO HYALUS GREEN LASER | 08/20/2012 |
| K031023 | PEREGRINE SURGICAL LTD. | PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10 | 06/27/2003 |
| K061024 | PEREGRINE SURGICAL LTD. | PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60 | 06/21/2006 |
| K220430 | Quantel Medical | Capsulo | 05/12/2022 |
| K170067 | Quantel Medical | Easyret | 07/25/2017 |
| K043236 | QUANTEL MEDICAL | FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA | 02/07/2005 |
| K023094 | QUANTEL MEDICAL | IRIDIS OPHTHALMIC PHOTOCOAGULATOR | 12/17/2002 |
| K140336 | QUANTEL MEDICAL | OPTIMUS FUSION: SLT, YAG AND YAG/SLT | 06/25/2014 |
| K043613 | QUANTEL MEDICAL | Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II | 03/24/2005 |
| K130933 | QUANTEL MEDICAL | SOLUTIS | 08/02/2013 |
| K091581 | QUANTEL MEDICAL | SUPRA 577.Y LASER | 06/16/2009 |
| K070776 | QUANTEL MEDICAL | SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR | 04/24/2007 |
| K120825 | QUANTEL MEDICAL | SUPRA SCAN DELIVERY SYSTEM | 09/14/2012 |
| K081946 | QUANTEL MEDICAL | SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR | 03/25/2009 |
| K201502 | Quantel Medical | Vitra 810 | 08/06/2020 |
| K112154 | SIE AG,SURGICAL INSTUMENT ENGINEERING | FEMTO LDV | 03/16/2012 |
| K081774 | SOLX INC. | SOLX 790 TITANIUM SAPPHIRE LASER | 09/12/2008 |
| K131207 | SURGICAL INSTRUMENT ENGINEERING AG | FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER | 10/09/2013 |
| K001772 | TARACAN PTY. LTD. | LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA | 07/06/2000 |
| K111108 | TOPCON MEDICAL LASER SYSTEMS, INC | PASCAL STREAMLINE 577 (WITH ACCESSORIES) | 08/11/2011 |
| K092621 | TOPCON MEDICAL LASER SYSTEMS, INC | PASCAL STREAMLINE PHOTOCOAGULATOR | 09/25/2009 |
| K123542 | TOPCON MEDICAL LASER SYSTEMS, INC | PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER | 05/15/2013 |
| K171488 | Topcon Medical Laser Systems, Inc. | PSLT for PASCAL Streamline | 11/27/2017 |
| K180402 | Topcon Medical Laser Systems, Inc. | PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar | 05/25/2018 |
| K123056 | TOPCON MEDICAL LASER SYSTEMS, INC. (TMLS) | PASCAL LASER INDIRECT OPHTHALMOSCOPE | 11/13/2012 |
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