Panels › Ophthalmic › Product code OOE · Class 2
Ophthalmic Femtosecond Laser
Regulation 886.4390
0510(k)s in 12 months (47 all time)
0recalls in 12 months (8 all time)
7recalls that name a 510(k)
Top companies in OOE
| Company | 510(k)s | Recalls |
|---|---|---|
| Lensar, Inc. | 13 | 0 |
| Technolas Perfect Vision GmbH | 9 | 0 |
| Amo Manufacturing USA, LLC | 5 | 1 |
| Optimedica Corporation | 4 | 2 |
| Alcon Laboratories, Inc. | 5 | 0 |
| Lensx Lasers, Inc. | 4 | 0 |
| Sie Ag,Surgical Instrument Engineering | 2 | 1 |
| Abbott Medical Optics, Inc. | 1 | 1 |
| Alcon Lensx, Inc. | 1 | 1 |
| Johnson & Johnson Surgical Vision, Inc. | 1 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 24, 2025 | K252682 | LenSx Laser System (8065000944) Alcon Laboratories, Inc. | OOE |
| Apr 28, 2025 | K243896 | LenSx Laser System (8065998162) Alcon Laboratories, Inc. | OOE |
| Apr 14, 2023 | K223566 | ELITA Femtosecond Laser System, ELITA Patient Interface Johnson & Johnson Surgical Vision, Inc. | OOE |
| Apr 12, 2023 | K223838 | Catalys Precision Laser System Amo Manufacturing USA, LLC | OOE |
| Jun 9, 2022 | K220259 | ALLY Adaptive Cataract Treatment System Lensar, Inc. | OOE |
| May 17, 2022 | K220516 | CATALYS Precision Laser system Amo Manufacturing USA, LLC | OOE |
| Apr 21, 2022 | K213559 | FEMTO LDV Z8 Femtosecond Surgical Laser Sie Ag,Surgical Instrument Engineering, CH | OOE |
| Apr 7, 2021 | K210701 | CATALYS Precision Laser System Amo Manufacturing USA, LLC | OOE |
| Sep 1, 2020 | K200724 | VICTUS Femtosecond Laser Platform Technolas Perfect Vision GmbH, DE | OOE |
| May 18, 2020 | K200056 | Catalys Precision Laser System Amo Manufacturng USA, LLC | OOE |
| Dec 21, 2018 | K182795 | LENSAR Laser System - fs 3D (LLS-fs 3D) Lensar, Inc. | OOE |
| Nov 9, 2018 | K182083 | Catalys Precision Laser System Amo Manufacturing USA, LLC | OOE |
| Aug 9, 2018 | K181430 | LENSAR Laser System - fs 3D (LLS-fs 3D) Lensar, Inc. | OOE |
| Mar 27, 2018 | K173660 | LenSx Laser System Alcon Laboratories, Inc. | OOE |
| Mar 2, 2018 | K173346 | LENSAR Laser System - fs 3D (LLS-fs 3D) Lensar, Inc. | OOE |
| Oct 19, 2017 | K171014 | VICTUS Femtosecond Laser Platform Technolas Perfect Vision GmbH, DE | OOE |
| Aug 25, 2017 | K172002 | Catalys Precision Laser System Amo Manufacturing USA, LLC | OOE |
| Aug 10, 2017 | K171337 | LENSAR Laser System fs 3D (LLS-fs 3D) Lensar, Inc. | OOE |
| May 19, 2017 | K170322 | Catalys Precision Laser System Abbott Medical Optics, Inc. | OOE |
| May 5, 2017 | K170576 | LENSAR Laser System - fs 3D (LLS-fs 3D) Lensar, Inc. | OOE |
| Feb 3, 2017 | K163551 | LenSx Laser System Alcon Laboratories, Inc. | OOE |
| Nov 16, 2016 | K161288 | LenSX Laser System Alcon Laboratories, Inc. | OOE |
| Sep 20, 2016 | K161455 | Catalys Precision Laser System Optimedica Corporation | OOE |
| Oct 23, 2015 | K150323 | FEMTO LDV Z8 Surgical Laser Sie Ag,Surgical Instrument Engineering, CH | OOE |
| Oct 15, 2015 | K152453 | LENSAR Laser System - fs 3D (LLS-fs 3D) Lensar, Inc. | OOE |
| Jun 24, 2015 | K151161 | VICTUS Femtosecond Laser Platform Technolas Perfect Vision GmbH, DE | OOE |
| Mar 20, 2015 | K143010 | LENSAR Laser System - fs 3D Lensar, Inc. | OOE |
| Jan 16, 2015 | K141379 | VICTUS FEMTOSECOND LASER PLATFORM Technolas Perfect Vision GmbH | OOE |
| Sep 30, 2014 | K141476 | WAVELIGHT FS200 LASER SYSTEM Alcon Research, Ltd. Dba Alcon Laboratories, Inc. | OOE |
| Sep 11, 2014 | K141079 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM Optimedica Corporation | OOE |
| Jul 15, 2014 | K140615 | VICTUS FEMTOSECOND LASER PLATFORM Technolas Perfect Vision GmbH | OOE |
| Feb 14, 2014 | K132534 | VICTUS FEMTOSECOND LASER PLATFORM Technolas Perfect Vision GmbH | OOE |
| Mar 27, 2013 | K123859 | TBD Lensar, Inc. | OOE |
| Feb 8, 2013 | K122386 | VICTUS FEMTOSECOND LASER PLATFORM Technolas Perfect Vision GmbH | OOE |
| Dec 12, 2012 | K123120 | LENSX LASER SYSTEM Alcon Lensx, Inc. | OOE |
| Aug 28, 2012 | K121091 | CATALYS PRECISION LASER SYSTEM Optimedica Corporation | OOE |
| Jul 31, 2012 | K120426 | VICTUS LASER PLATFORM Technolas Perfect Vision GmbH | OOE |
| Jun 8, 2012 | K120214 | TBD Lensar, Inc. | OOE |
| Dec 21, 2011 | K113479 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM Optimedica Corporation | OOE |
| Nov 22, 2011 | K110427 | FEMTEC LASER SYSTEM FOR CAPSULOTOMY Technolas Perfect Vision GmbH | OOE |
| Oct 19, 2011 | K112098 | TBD Lensar, Inc. | OOE |
| Mar 16, 2011 | K102727 | LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY Lensar, Inc. | OOE |
| Oct 18, 2010 | K101626 | LENSX LASER SYSTEM Lensx Lasers, Inc. | OOE |
| May 13, 2010 | K090633 | LENSAR LASER SYSTEM Lensar, Inc. | OOE |
| Apr 23, 2010 | K094052 | LENSX 550 LASER SYSTEM. MODEL 550 Lensx Lasers, Inc. | OOE |
| Dec 11, 2009 | K092647 | LENSX 550 LASER SYSTEM Lensx Lasers, Inc. | OOE |
| Aug 14, 2009 | K082947 | LENSX 550 LASER SYSTEM Lensx Lasers, Inc. | OOE |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.