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 |
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 |