Atlas FDA

OOE

47 FDA 510(k) clearances · Product code

126 daysmedian time to decision
234 days90th percentile
47clearances measured

FDA profile

Official device name
Ophthalmic Femtosecond Laser
Device class
Class II (moderate risk)
Regulation
21 CFR 886.4390
Medical specialty
Ophthalmic
FDA definition
Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.
Adverse events (MAUDE)
2021: 328 · 2022: 204 · 2023: 231 · 2024: 368 · 2025: 518 · 2026: 243
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
LenSx Laser System (8065000944) (K252682)Alcon Laboratories, Inc.2025-09-24
LenSx Laser System (8065998162) (K243896)Alcon Laboratories, Inc.2025-04-28
ELITA™ Femtosecond Laser System, ELITA™ Patient Interface (K223566)Johnson & Johnson Surgical Vision, Inc.2023-04-14
Catalys™ Precision Laser System (K223838)Amo Manufacturing USA, LLC2023-04-12
ALLY Adaptive Cataract Treatment System (K220259)Lensar, Inc.2022-06-09
CATALYS Precision Laser system (K220516)Amo Manufacturing USA, LLC2022-05-17
FEMTO LDV Z8 Femtosecond Surgical Laser (K213559)Sie Ag,Surgical Instrument Engineering2022-04-21
CATALYS Precision Laser System (K210701)Amo Manufacturing USA, LLC2021-04-07
VICTUS Femtosecond Laser Platform (K200724)Technolas Perfect Vision GmbH2020-09-01
Catalys Precision Laser System (K200056)Amo Manufacturng USA, LLC2020-05-18
LENSAR Laser System - fs 3D (LLS-fs 3D) (K182795)Lensar, Inc.2018-12-21
Catalys Precision Laser System (K182083)Amo Manufacturing USA, LLC2018-11-09
LENSAR Laser System - fs 3D (LLS-fs 3D) (K181430)Lensar, Inc.2018-08-09
LenSx Laser System (K173660)Alcon Laboratories, Inc.2018-03-27
LENSAR Laser System - fs 3D (LLS-fs 3D) (K173346)Lensar, Inc.2018-03-02
VICTUS Femtosecond Laser Platform (K171014)Technolas Perfect Vision GmbH2017-10-19
Catalys Precision Laser System (K172002)Amo Manufacturing USA, LLC2017-08-25
LENSAR Laser System – fs 3D (LLS-fs 3D) (K171337)Lensar, Inc.2017-08-10
Catalys Precision Laser System (K170322)Abbott Medical Optics, Inc.2017-05-19
LENSAR Laser System - fs 3D (LLS-fs 3D) (K170576)Lensar, Inc.2017-05-05
LenSx Laser System (K163551)Alcon Laboratories, Inc.2017-02-03
LenSX Laser System (K161288)Alcon Laboratories, Inc.2016-11-16
Catalys Precision Laser System (K161455)Optimedica Corporation2016-09-20
FEMTO LDV Z8 Surgical Laser (K150323)Sie Ag,Surgical Instrument Engineering2015-10-23
LENSAR Laser System - fs 3D (LLS-fs 3D) (K152453)Lensar, Inc.2015-10-15
VICTUS Femtosecond Laser Platform (K151161)Technolas Perfect Vision GmbH2015-06-24
LENSAR Laser System - fs 3D (K143010)Lensar, Inc.2015-03-20
VICTUS FEMTOSECOND LASER PLATFORM (K141379)Technolas Perfect Vision GmbH2015-01-16
WAVELIGHT FS200 LASER SYSTEM (K141476)Alcon Research, Ltd. Dba Alcon Laboratories, Inc.2014-09-30
OPTIMEDICA CATALYS PRECISION LASER SYSTEM (K141079)Optimedica Corporation2014-09-11
VICTUS FEMTOSECOND LASER PLATFORM (K140615)Technolas Perfect Vision GmbH2014-07-15
VICTUS FEMTOSECOND LASER PLATFORM (K132534)Technolas Perfect Vision GmbH2014-02-14
TBD (K123859)Lensar, Inc.2013-03-27
VICTUS FEMTOSECOND LASER PLATFORM (K122386)Technolas Perfect Vision GmbH2013-02-08
LENSX LASER SYSTEM (K123120)Alcon Lensx, Inc.2012-12-12
CATALYS PRECISION LASER SYSTEM (K121091)Optimedica Corporation2012-08-28
VICTUS LASER PLATFORM (K120426)Technolas Perfect Vision GmbH2012-07-31
TBD (K120214)Lensar, Inc.2012-06-08
OPTIMEDICA CATALYS PRECISION LASER SYSTEM (K113479)Optimedica Corporation2011-12-21
FEMTEC LASER SYSTEM FOR CAPSULOTOMY (K110427)Technolas Perfect Vision GmbH2011-11-22
TBD (K112098)Lensar, Inc.2011-10-19
LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY (K102727)Lensar, Inc.2011-03-16
LENSX LASER SYSTEM (K101626)Lensx Lasers, Inc.2010-10-18
LENSAR LASER SYSTEM (K090633)Lensar, Inc.2010-05-13
LENSX 550 LASER SYSTEM. MODEL 550 (K094052)Lensx Lasers, Inc.2010-04-23
LENSX 550 LASER SYSTEM (K092647)Lensx Lasers, Inc.2009-12-11
LENSX 550 LASER SYSTEM (K082947)Lensx Lasers, Inc.2009-08-14

Track OOE automatically

Every clearance here is in the API, with alerts when new ones post.