Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lensar, Inc. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
103 daysmedian FDA review time
175 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220259 | ALLY Adaptive Cataract Treatment System | Lensar, Inc. | 2022-06-09 | 129 | 0 |
| K182795 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018-12-21 | 81 | 0 |
| K181430 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018-08-09 | 69 | 0 |
| K173346 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018-03-02 | 128 | 0 |
| K171337 | LENSAR Laser System – fs 3D (LLS-fs 3D) | Lensar, Inc. | 2017-08-10 | 94 | 0 |
| K170576 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2017-05-05 | 67 | 0 |
| K152453 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2015-10-15 | 48 | 0 |
| K143010 | LENSAR Laser System - fs 3D | Lensar, Inc. | 2015-03-20 | 151 | 0 |
| K123859 | TBD | Lensar, Inc. | 2013-03-27 | 103 | 0 |
| K122829 | LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS | Lensar, Inc. | 2012-12-03 | 77 | 0 |
| K120214 | TBD | Lensar, Inc. | 2012-06-08 | 136 | 0 |
| K112098 | TBD | Lensar, Inc. | 2011-10-19 | 89 | 0 |
| K102727 | LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY | Lensar, Inc. | 2011-03-16 | 175 | 0 |
| K090633 | LENSAR LASER SYSTEM | Lensar, Inc. | 2010-05-13 | 430 | 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