Atlas FDA

HQF

180 FDA 510(k) clearances · Product code

90 daysmedian time to decision
267 days90th percentile
180clearances measured

FDA profile

Official device name
Laser, Ophthalmic
Device class
Class II (moderate risk)
Regulation
21 CFR 886.4390
Medical specialty
Ophthalmic
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 100 · 2022: 111 · 2023: 92 · 2024: 75 · 2025: 106 · 2026: 39
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Voyager DSLT (430840610) (K252979)Belkin Vision, Ltd.2026-04-07
INTEGRE LIO (K251507)Quantel Medical2026-02-06
Navilas Laser System 577sl (156691) (K251772)Od-Os GmbH2025-10-29
EyeQ nanoECP (K243014)Eyeq, Inc.2025-06-18
Leos Laser and Endoscopy System (K240615)Beaver-Visitec International, Inc.2025-04-03
LYNX Photocoagulator (K242397)Norlase Aps2024-10-25
VISULAS combi (K233911)Carl Zeiss Meditec, AG2024-09-06
MR Q; MR Q SUPINE; MR Q SLT (K232417)Meridian AG2024-01-25
Eagle device (K230722)Belkin Vision, Ltd.2023-12-08
VISULAS green (K232051)Carl Zeiss Meditec2023-10-24
VISULAS yag (K230350)Carl Zeiss Meditec, Inc.2023-09-22
Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse (K231011)Meridian AG2023-09-12
Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) (K230228)Iridex Corporation2023-02-23
R:GEN (K220974)Lutronic Vision, Inc.2022-12-27
Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) (K223132)Iridex Corporation2022-11-09
Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo (K222395)Ellex Medical Pty, Ltd.2022-11-02
ECHO Photocoagulator (K222157)Norlase2022-10-11
Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems (K220877)Lumenis Be, Inc.2022-07-15
Capsulo (K220430)Quantel Medical2022-05-12
Iridex 810 Laser (K213592)Iridex Corporation2022-03-23
Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo (K212630)Ellex Medical Pty, Ltd.2021-12-16
Ophthalmic Yag Laser System YC-200 (K203130)Nidek Co., Ltd.2020-12-07
Iridex 810 Laser (K202760)Iridex Corporation2020-10-21
LION Photocoagulator (K201623)Norlase Aps2020-08-11
Vitra 810 (K201502)Quantel Medical2020-08-06
Ophthalmic Yag Laser System YC-200 (K192045)Nidek Co., Ltd.2019-11-15
LightLas Pattern Scanning System - TruScan Pro (K190448)Light-Med(Usa), Inc.2019-05-24
Leaf Photocoagulator (K190083)Norlase Aps2019-05-03
VISULAS green (K181682)Carl Zeiss Meditec, AG2019-03-06
PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar (K180402)Topcon Medical Laser Systems, Inc.2018-05-25
PSLT for PASCAL Streamline (K171488)Topcon Medical Laser Systems, Inc.2017-11-27
Easyret (K170067)Quantel Medical2017-07-25
YELLOW LASER PHOTOCOAGULATOR YLC-500 (K170302)Nidek Co., Ltd.2017-06-23
R:GEN Laser System (K153769)Lutronic Corporation2016-10-05
LightLas Multi-Wavelength Medical Laser System (K152688)Lightmed Corporation2016-06-15
Green Laser Photocoagulator GYC-500 (K152603)Nidek Co., Ltd.2016-05-02
Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow (K142398)Ellex Medical Pty, Ltd.2015-07-14
Ophthalmed Bending Laser Probes (K142830)Ophthalmed, LLC2015-06-25
LIGHTMED TRUSCAN 577 (K142172)Lightmed Corp.2015-02-27
FIBERION OPHTHALMIC ENDOLASER PROBE (K133019)Emtron Elektronik VE Mekanik Sanayi VE Ticaret Lim2015-02-20
KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES (K140362)Katalyst Surgical, LLC2014-09-15
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT (K133358)Nidek Co., Ltd.2014-08-12
OPTIMUS FUSION: SLT, YAG AND YAG/SLT (K140336)Quantel Medical2014-06-25
SCANNING LASERLINK (K130195)Lumenis, Inc.2013-11-01
FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER (K131207)Surgical Instrument Engineering AG2013-10-09
LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM (K124043)Lightmed Corp.2013-09-26
SOLUTIS (K130933)Quantel Medical2013-08-02
ELLEX 2RT (K122202)Ellex Medical Pty, Ltd.2013-07-01
PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER (K123542)Topcon Medical Laser Systems, Inc.2013-05-15
PASCAL LASER INDIRECT OPHTHALMOSCOPE (K123056)Topcon Medical Laser Systems, Inc. (Tmls)2012-11-13
KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES (K121187)Katalyst Surgical, LLC2012-09-17
SUPRA SCAN DELIVERY SYSTEM (K120825)Quantel Medical2012-09-14
OPTO HYALUS GREEN LASER (K111460)Opto Eletronica S/A2012-08-20
FEMTO LDV (K112154)Sie Ag,Surgical Instument Engineering2012-03-16
OPTO MITRA YELLOW LASER (K111643)Opto Electronica SA2011-11-03
LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM (K103547)Lightmed Corp.2011-11-03
PASCAL STREAMLINE 577 (WITH ACCESSORIES) (K111108)Topcon Medical Laser Systems, Inc.2011-08-11
VISULAS TRION LASER SYSTEM WITH THE VITE OPTION (K103056)Carl Zeiss Meditec, AG2011-02-01
VISUMAX LASER KERATOME (K100253)Carl Zeiss Meditec, AG2010-07-08
PASCAL STREAMLINE PHOTOCOAGULATOR (K100019)Optimedica Corporation2010-05-04
NAVILAS LASER SYSTEM (K091064)Od-Os GmbH2009-10-27
LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER (K091981)Lightmed Corp.2009-09-28
PASCAL STREAMLINE PHOTOCOAGULATOR (K092621)Topcon Medical Laser Systems, Inc.2009-09-25
LIGHTLAS MODEL 532 (K091534)Lightmed Corp.2009-09-18
LIGHTLAS SELECTOR (K090774)Lightmed Corp.2009-08-13
SUPRA 577.Y LASER (K091581)Quantel Medical2009-06-16
SUPRA TWIN OPHTHALMIC LASER PHOTOCOAGULATOR (K081946)Quantel Medical2009-03-25
SOLX 790 TITANIUM SAPPHIRE LASER (K081774)Solx, Inc.2008-09-12
INTEGRE PRO, MODEL L2RY (K081565)Ellex Medical Pty, Ltd.2008-07-02
INTEGRE, MODEL LP581 (K080423)Ellex Medical Pty, Ltd.2008-03-11
MERILAS 532A (K072823)Meridian AG2007-12-14
NEXT GENERATION LASER (K062624)Alcon Laboratories2007-11-05
LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR (K063297)Lightmed Corp.2007-09-20
SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR (K070776)Quantel Medical2007-04-24
IRIDEX WIRELESS FOOTSWITCH (K062074)Iridex Corp2006-11-14
PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60 (K061024)Peregrine Surgical , Ltd.2006-06-21
FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES (K051944)Lumenis, Inc.2005-09-30
20G SMA LASER FIBER, MODEL LF100 (K050807)Ophthalmed, LLC2005-09-21
OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY (K050541)Omniguide Communications, Inc.2005-05-09
Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II (K043613)Quantel Medical2005-03-24
FREQUENCY DOUBLED ND: YAG PHOTOCOAGULATOR, MODEL VITRA (K043236)Quantel Medical2005-02-07
LASEREX, MODEL LP4532 (K041598)Ellex Medical Pty, Ltd.2004-10-06
IRIS MEDICAL IQ 810 PHOTOCOAGULATOR (K040209)Iridex Corp2004-09-20
MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK (K033941)Bausch & Lomb, Inc.2004-02-10
IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS (K031665)Iridex Corp2003-08-27
PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10 (K031023)Peregrine Surgical , Ltd.2003-06-27
IRIDIS OPHTHALMIC PHOTOCOAGULATOR (K023094)Quantel Medical2002-12-17
LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR (K021538)Lightmed Corp.2002-08-08
OCULIGHT SL/SLX (K020374)Iridex Corp2002-05-03
DC-3300 LASER DIODE PHOTOCOAGULATOR (K013760)Nidek, Inc.2002-02-11
LIGHTLAS 532 PHOTOCOAGULATOR (K010372)Lightmed Corp.2001-08-22
LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA (K001772)Taracan Pty. , Ltd.2000-07-06
BQ/BM INTEGRATED LASER DELIVERY SYSTEM (K990665)American Laser Corp.1999-05-17
LPULSA SYL-9000 OPHTHALMIC YAG LASER (K990075)Light-Med(Usa), Inc.1999-03-30
MEDITEC LINK (K981196)Aesculap-Meditec North America1998-06-17
LUXSCOPE (K973193)Luxtec Corp.1997-11-21
RODENSTOCK LASER SLITLAMP (K973220)G. Rodenstock Instrumente GmbH1997-11-04
LASEREX LP1532 PHOTOCOAGULATOR (K972514)Ellex Medical Pty, Ltd.1997-10-03
INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER (K971950)Infinitech, Inc.1997-08-01
CERALAS DIODE LASER SYSTEM (CERALAS D2) (K964751)Ceram Optec, Inc.1997-02-21
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Every clearance here is in the API, with alerts when new ones post.