FDA Product Code
FDA Product Code OOE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.4390
510(k) Clearances — 47 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252682 | LenSx Laser System (8065000944) | Alcon Laboratories, Inc. | 2025-09-24 | Special | PDF ↗ |
| K243896 | LenSx Laser System (8065998162) | Alcon Laboratories, Inc. | 2025-04-28 | Traditional | PDF ↗ |
| K223566 | ELITA Femtosecond Laser System, ELITA Patient Interface | Johnson & Johnson Surgical Vision, Inc. | 2023-04-14 | Traditional | PDF ↗ |
| K223838 | Catalys Precision Laser System | Amo Manufacturing USA, LLC | 2023-04-12 | Traditional | PDF ↗ |
| K220259 | ALLY Adaptive Cataract Treatment System | Lensar, Inc. | 2022-06-09 | Traditional | PDF ↗ |
| K220516 | CATALYS Precision Laser system | Amo Manufacturing USA, LLC | 2022-05-17 | Traditional | PDF ↗ |
| K213559 | FEMTO LDV Z8 Femtosecond Surgical Laser | Sie Ag,Surgical Instrument Engineering | 2022-04-21 | Traditional | PDF ↗ |
| K210701 | CATALYS Precision Laser System | Amo Manufacturing USA, LLC | 2021-04-07 | Special | PDF ↗ |
| K200724 | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2020-09-01 | Traditional | PDF ↗ |
| K200056 | Catalys Precision Laser System | Amo Manufacturng USA, LLC | 2020-05-18 | Traditional | PDF ↗ |
| K182795 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018-12-21 | Traditional | PDF ↗ |
| K182083 | Catalys Precision Laser System | Amo Manufacturing USA, LLC | 2018-11-09 | Traditional | PDF ↗ |
| K181430 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018-08-09 | Traditional | PDF ↗ |
| K173660 | LenSx Laser System | Alcon Laboratories, Inc. | 2018-03-27 | Traditional | PDF ↗ |
| K173346 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018-03-02 | Traditional | PDF ↗ |
| K171014 | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2017-10-19 | Traditional | PDF ↗ |
| K172002 | Catalys Precision Laser System | Amo Manufacturing USA, LLC | 2017-08-25 | Traditional | PDF ↗ |
| K171337 | LENSAR Laser System fs 3D (LLS-fs 3D) | Lensar, Inc. | 2017-08-10 | Traditional | PDF ↗ |
| K170322 | Catalys Precision Laser System | Abbott Medical Optics, Inc. | 2017-05-19 | Traditional | PDF ↗ |
| K170576 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2017-05-05 | Traditional | PDF ↗ |
| K163551 | LenSx Laser System | Alcon Laboratories, Inc. | 2017-02-03 | Traditional | PDF ↗ |
| K161288 | LenSX Laser System | Alcon Laboratories, Inc. | 2016-11-16 | Traditional | PDF ↗ |
| K161455 | Catalys Precision Laser System | Optimedica Corporation | 2016-09-20 | Traditional | PDF ↗ |
| K150323 | FEMTO LDV Z8 Surgical Laser | Sie Ag,Surgical Instrument Engineering | 2015-10-23 | Traditional | PDF ↗ |
| K152453 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2015-10-15 | Special | PDF ↗ |
| K151161 | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2015-06-24 | Traditional | PDF ↗ |
| K143010 | LENSAR Laser System - fs 3D | Lensar, Inc. | 2015-03-20 | Traditional | PDF ↗ |
| K141379 | VICTUS FEMTOSECOND LASER PLATFORM | Technolas Perfect Vision GmbH | 2015-01-16 | Traditional | PDF ↗ |
| K141476 | WAVELIGHT FS200 LASER SYSTEM | Alcon Research, Ltd. Dba Alcon Laboratories, Inc. | 2014-09-30 | Traditional | PDF ↗ |
| K141079 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM | Optimedica Corporation | 2014-09-11 | Traditional | PDF ↗ |
| K140615 | VICTUS FEMTOSECOND LASER PLATFORM | Technolas Perfect Vision GmbH | 2014-07-15 | Traditional | PDF ↗ |
| K132534 | VICTUS FEMTOSECOND LASER PLATFORM | Technolas Perfect Vision GmbH | 2014-02-14 | Traditional | PDF ↗ |
| K123859 | TBD | Lensar, Inc. | 2013-03-27 | Traditional | PDF ↗ |
| K122386 | VICTUS FEMTOSECOND LASER PLATFORM | Technolas Perfect Vision GmbH | 2013-02-08 | Traditional | PDF ↗ |
| K123120 | LENSX LASER SYSTEM | Alcon Lensx, Inc. | 2012-12-12 | Traditional | PDF ↗ |
| K121091 | CATALYS PRECISION LASER SYSTEM | Optimedica Corporation | 2012-08-28 | Traditional | PDF ↗ |
| K120426 | VICTUS LASER PLATFORM | Technolas Perfect Vision GmbH | 2012-07-31 | Traditional | PDF ↗ |
| K120214 | TBD | Lensar, Inc. | 2012-06-08 | Traditional | PDF ↗ |
| K113479 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM | Optimedica Corporation | 2011-12-21 | Traditional | PDF ↗ |
| K110427 | FEMTEC LASER SYSTEM FOR CAPSULOTOMY | Technolas Perfect Vision GmbH | 2011-11-22 | Traditional | PDF ↗ |
| K112098 | TBD | Lensar, Inc. | 2011-10-19 | Traditional | PDF ↗ |
| K102727 | LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY | Lensar, Inc. | 2011-03-16 | Traditional | PDF ↗ |
| K101626 | LENSX LASER SYSTEM | Lensx Lasers, Inc. | 2010-10-18 | Traditional | PDF ↗ |
| K090633 | LENSAR LASER SYSTEM | Lensar, Inc. | 2010-05-13 | Traditional | PDF ↗ |
| K094052 | LENSX 550 LASER SYSTEM. MODEL 550 | Lensx Lasers, Inc. | 2010-04-23 | Traditional | PDF ↗ |
| K092647 | LENSX 550 LASER SYSTEM | Lensx Lasers, Inc. | 2009-12-11 | Traditional | PDF ↗ |
| K082947 | LENSX 550 LASER SYSTEM | Lensx Lasers, Inc. | 2009-08-14 | Traditional | PDF ↗ |
Product code OOE · Class II · Ophthalmic. Data: openFDA.