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 |
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 |
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 |
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 |
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 |