Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OOE — Predicate Candidate Screening
47 FDA 510(k) clearances under this product code; the 50 most recent screened below.
126 daysmedian FDA review time
234 days90th percentile
47clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252682 | LenSx Laser System (8065000944) | Alcon Laboratories, Inc. | 2025-09-24 | 30 | 0 |
| K243896 | LenSx Laser System (8065998162) | Alcon Laboratories, Inc. | 2025-04-28 | 131 | 0 |
| K223566 | ELITA™ Femtosecond Laser System, ELITA™ Patient Interface | Johnson & Johnson Surgical Vision, Inc. | 2023-04-14 | 136 | 0 |
| K223838 | Catalys™ Precision Laser System | Amo Manufacturing USA, LLC | 2023-04-12 | 111 | 0 |
| K220259 | ALLY Adaptive Cataract Treatment System | Lensar, Inc. | 2022-06-09 | 129 | 0 |
| K220516 | CATALYS Precision Laser system | Amo Manufacturing USA, LLC | 2022-05-17 | 83 | 0 |
| K213559 | FEMTO LDV Z8 Femtosecond Surgical Laser | Sie Ag,Surgical Instrument Engineering | 2022-04-21 | 168 | 0 |
| K210701 | CATALYS Precision Laser System | Amo Manufacturing USA, LLC | 2021-04-07 | 29 | 0 |
| K200724 | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2020-09-01 | 166 | 0 |
| K200056 | Catalys Precision Laser System | Amo Manufacturng USA, LLC | 2020-05-18 | 126 | 0 |
| K182795 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018-12-21 | 81 | 0 |
| K182083 | Catalys Precision Laser System | Amo Manufacturing USA, LLC | 2018-11-09 | 99 | 0 |
| K181430 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018-08-09 | 69 | 0 |
| K173660 | LenSx Laser System | Alcon Laboratories, Inc. | 2018-03-27 | 118 | 0 |
| K173346 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018-03-02 | 128 | 0 |
| K171014 | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2017-10-19 | 198 | 0 |
| K172002 | Catalys Precision Laser System | Amo Manufacturing USA, LLC | 2017-08-25 | 53 | 0 |
| K171337 | LENSAR Laser System – fs 3D (LLS-fs 3D) | Lensar, Inc. | 2017-08-10 | 94 | 0 |
| K170322 | Catalys Precision Laser System | Abbott Medical Optics, Inc. | 2017-05-19 | 107 | 0 |
| K170576 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2017-05-05 | 67 | 0 |
| K163551 | LenSx Laser System | Alcon Laboratories, Inc. | 2017-02-03 | 46 | 0 |
| K161288 | LenSX Laser System | Alcon Laboratories, Inc. | 2016-11-16 | 191 | 0 |
| K161455 | Catalys Precision Laser System | Optimedica Corporation | 2016-09-20 | 117 | 0 |
| K150323 | FEMTO LDV Z8 Surgical Laser | Sie Ag,Surgical Instrument Engineering | 2015-10-23 | 256 | 0 |
| K152453 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2015-10-15 | 48 | 0 |
| K151161 | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2015-06-24 | 54 | 0 |
| K143010 | LENSAR Laser System - fs 3D | Lensar, Inc. | 2015-03-20 | 151 | 0 |
| K141379 | VICTUS FEMTOSECOND LASER PLATFORM | Technolas Perfect Vision GmbH | 2015-01-16 | 234 | 0 |
| K141476 | WAVELIGHT FS200 LASER SYSTEM | Alcon Research, Ltd. Dba Alcon Laboratories, Inc. | 2014-09-30 | 118 | 0 |
| K141079 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM | Optimedica Corporation | 2014-09-11 | 139 | 2 |
| K140615 | VICTUS FEMTOSECOND LASER PLATFORM | Technolas Perfect Vision GmbH | 2014-07-15 | 127 | 0 |
| K132534 | VICTUS FEMTOSECOND LASER PLATFORM | Technolas Perfect Vision GmbH | 2014-02-14 | 185 | 0 |
| K123859 | TBD | Lensar, Inc. | 2013-03-27 | 103 | 0 |
| K122386 | VICTUS FEMTOSECOND LASER PLATFORM | Technolas Perfect Vision GmbH | 2013-02-08 | 186 | 0 |
| K123120 | LENSX LASER SYSTEM | Alcon Lensx, Inc. | 2012-12-12 | 70 | 0 |
| K121091 | CATALYS PRECISION LASER SYSTEM | Optimedica Corporation | 2012-08-28 | 140 | 1 |
| K120426 | VICTUS LASER PLATFORM | Technolas Perfect Vision GmbH | 2012-07-31 | 169 | 0 |
| K120214 | TBD | Lensar, Inc. | 2012-06-08 | 136 | 0 |
| K113479 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM | Optimedica Corporation | 2011-12-21 | 28 | 0 |
| K110427 | FEMTEC LASER SYSTEM FOR CAPSULOTOMY | Technolas Perfect Vision GmbH | 2011-11-22 | 281 | 0 |
| K112098 | TBD | Lensar, Inc. | 2011-10-19 | 89 | 0 |
| K102727 | LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY | Lensar, Inc. | 2011-03-16 | 175 | 0 |
| K101626 | LENSX LASER SYSTEM | Lensx Lasers, Inc. | 2010-10-18 | 131 | 0 |
| K090633 | LENSAR LASER SYSTEM | Lensar, Inc. | 2010-05-13 | 430 | 0 |
| K094052 | LENSX 550 LASER SYSTEM. MODEL 550 | Lensx Lasers, Inc. | 2010-04-23 | 113 | 0 |
| K092647 | LENSX 550 LASER SYSTEM | Lensx Lasers, Inc. | 2009-12-11 | 106 | 0 |
| K082947 | LENSX 550 LASER SYSTEM | Lensx Lasers, Inc. | 2009-08-14 | 316 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda