FDA 510(k) Applications for Medical Device Product Code "OOE"
(Ophthalmic Femtosecond Laser)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K170322 | Abbott Medical Optics Inc. | Catalys Precision Laser System | 05/19/2017 |
| K161288 | ALCON LABORATORIES, INC. | LenSX Laser System | 11/16/2016 |
| K163551 | Alcon Laboratories, Inc. | LenSx Laser System | 02/03/2017 |
| K173660 | Alcon Laboratories, Inc. | LenSx Laser System | 03/27/2018 |
| K243896 | Alcon Laboratories, Inc. | LenSx Laser System (8065998162) | 04/28/2025 |
| K123120 | ALCON LENSX, INC. | LENSX LASER SYSTEM | 12/12/2012 |
| K141476 | ALCON RESEARCH, LTD. DBA ALCON LABORATORIES, INC. | WAVELIGHT FS200 LASER SYSTEM | 09/30/2014 |
| K172002 | AMO Manufacturing USA, LLC | Catalys Precision Laser System | 08/25/2017 |
| K182083 | AMO Manufacturing USA, LLC | Catalys Precision Laser System | 11/09/2018 |
| K210701 | AMO Manufacturing USA, LLC | CATALYS Precision Laser System | 04/07/2021 |
| K220516 | AMO Manufacturing USA, LLC | CATALYS Precision Laser system | 05/17/2022 |
| K223838 | AMO Manufacturing USA, LLC | CatalysÖ Precision Laser System | 04/12/2023 |
| K200056 | AMO Manufacturng USA, LLC | Catalys Precision Laser System | 05/18/2020 |
| K223566 | Johnson & Johnson Surgical Vision, Inc. | ELITAÖ Femtosecond Laser System, ELITAÖ Patient Interface | 04/14/2023 |
| K220259 | Lensar, Inc. | ALLY Adaptive Cataract Treatment System | 06/09/2022 |
| K090633 | LENSAR, INC. | LENSAR LASER SYSTEM | 05/13/2010 |
| K143010 | LENSAR, INC. | LENSAR Laser System - fs 3D | 03/20/2015 |
| K152453 | LENSAR, Inc. | LENSAR Laser System - fs 3D (LLS-fs 3D) | 10/15/2015 |
| K173346 | Lensar, Inc. | LENSAR Laser System - fs 3D (LLS-fs 3D) | 03/02/2018 |
| K170576 | LENSAR, Inc. | LENSAR Laser System - fs 3D (LLS-fs 3D) | 05/05/2017 |
| K181430 | LENSAR, Inc. | LENSAR Laser System - fs 3D (LLS-fs 3D) | 08/09/2018 |
| K182795 | Lensar, Inc. | LENSAR Laser System - fs 3D (LLS-fs 3D) | 12/21/2018 |
| K102727 | LENSAR, INC. | LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY | 03/16/2011 |
| K171337 | LENSAR, Inc. | LENSAR Laser System û fs 3D (LLS-fs 3D) | 08/10/2017 |
| K112098 | LENSAR, INC. | TBD | 10/19/2011 |
| K120214 | LENSAR, INC. | TBD | 06/08/2012 |
| K123859 | LENSAR, INC. | TBD | 03/27/2013 |
| K082947 | LENSX LASERS, INC. | LENSX 550 LASER SYSTEM | 08/14/2009 |
| K092647 | LENSX LASERS, INC. | LENSX 550 LASER SYSTEM | 12/11/2009 |
| K094052 | LENSX LASERS, INC. | LENSX 550 LASER SYSTEM. MODEL 550 | 04/23/2010 |
| K101626 | LENSX LASERS, INC. | LENSX LASER SYSTEM | 10/18/2010 |
| K161455 | Optimedica Corporation | Catalys Precision Laser System | 09/20/2016 |
| K121091 | OPTIMEDICA CORPORATION | CATALYS PRECISION LASER SYSTEM | 08/28/2012 |
| K141079 | OPTIMEDICA CORPORATION | OPTIMEDICA CATALYS PRECISION LASER SYSTEM | 09/11/2014 |
| K113479 | OPTIMEDICA CORPORATION | OPTIMEDICA CATALYS PRECISION LASER SYSTEM | 12/21/2011 |
| K213559 | SIE AG, Surgical Instrument Engineering | FEMTO LDV Z8 Femtosecond Surgical Laser | 04/21/2022 |
| K150323 | SIE AG,Surgical Instrument Engineering | FEMTO LDV Z8 Surgical Laser | 10/23/2015 |
| K110427 | TECHNOLAS PERFECT VISION GMBH | FEMTEC LASER SYSTEM FOR CAPSULOTOMY | 11/22/2011 |
| K132534 | TECHNOLAS PERFECT VISION GMBH | VICTUS FEMTOSECOND LASER PLATFORM | 02/14/2014 |
| K141379 | TECHNOLAS PERFECT VISION GMBH | VICTUS FEMTOSECOND LASER PLATFORM | 01/16/2015 |
| K200724 | Technolas Perfect Vision GmbH | VICTUS Femtosecond Laser Platform | 09/01/2020 |
| K151161 | TECHNOLAS PERFECT VISION GMBH | VICTUS Femtosecond Laser Platform | 06/24/2015 |
| K171014 | Technolas Perfect Vision GmbH | VICTUS Femtosecond Laser Platform | 10/19/2017 |
| K122386 | TECHNOLAS PERFECT VISION GMBH | VICTUS FEMTOSECOND LASER PLATFORM | 02/08/2013 |
| K140615 | TECHNOLAS PERFECT VISION GMBH | VICTUS FEMTOSECOND LASER PLATFORM | 07/15/2014 |
| K120426 | TECHNOLAS PERFECT VISION GMBH | VICTUS LASER PLATFORM | 07/31/2012 |
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