Lensar, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Lensar, Inc.” (first 2010, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 98 days. Since 2017 the median was 88 days, against 132 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 106 |
| 2013 | 1 | 103 |
| 2014 | 0 | — |
| 2015 | 2 | 100 |
| 2016 | 0 | — |
| 2017 | 2 | 80 |
| 2018 | 3 | 81 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 129 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Lensar, Inc. took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OOE | Ophthalmic Femtosecond Laser | 13 | 13 |
| HQC | Unit, Phacofragmentation | 1 | 1 |
Review panels
- Ophthalmic (14)
Most recent Lensar, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220259 | ALLY Adaptive Cataract Treatment System | OOE | 2022-06-09 | 129 |
| K182795 | LENSAR Laser System - fs 3D (LLS-fs 3D) | OOE | 2018-12-21 | 81 |
| K181430 | LENSAR Laser System - fs 3D (LLS-fs 3D) | OOE | 2018-08-09 | 69 |
| K173346 | LENSAR Laser System - fs 3D (LLS-fs 3D) | OOE | 2018-03-02 | 128 |
| K171337 | LENSAR Laser System fs 3D (LLS-fs 3D) | OOE | 2017-08-10 | 94 |
| K170576 | LENSAR Laser System - fs 3D (LLS-fs 3D) | OOE | 2017-05-05 | 67 |
| K152453 | LENSAR Laser System - fs 3D (LLS-fs 3D) | OOE | 2015-10-15 | 48 |
| K143010 | LENSAR Laser System - fs 3D | OOE | 2015-03-20 | 151 |
| K123859 | TBD | OOE | 2013-03-27 | 103 |
| K122829 | LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS | HQC | 2012-12-03 | 77 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Lensar, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
SEC filings
LENSAR, Inc. (LNSR): EDGAR filings, CIK 1320350. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Lensar, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Lensar, Inc.” (first 2010, latest 2022), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Lensar, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lensar, Inc. is 98 days. Since 2017: 88 days, versus 132 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Lensar, Inc.?
The most frequent FDA product codes under this applicant name are OOE (Ophthalmic Femtosecond Laser, 13); HQC (Unit, Phacofragmentation, 1).
Next steps
- See all 14 Lensar, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OOE, Lensar, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.