LENSAR, Inc
Orlando, FL, US
LENSAR, Inc appears in FDA device records in Orlando, FL. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 14 510(k) clearances for LENSAR, Inc between 2010 and 2022. The busiest year on record is 2018, with 3. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 2 |
| 2013 | 1 |
| 2015 | 2 |
| 2017 | 2 |
| 2018 | 3 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220259 | ALLY Adaptive Cataract Treatment System | OOE | Substantially Equivalent | |
| K182795 | LENSAR Laser System - fs 3D (LLS-fs 3D) | OOE | Substantially Equivalent | |
| K181430 | LENSAR Laser System - fs 3D (LLS-fs 3D) | OOE | Substantially Equivalent | |
| K173346 | LENSAR Laser System - fs 3D (LLS-fs 3D) | OOE | Substantially Equivalent | |
| K171337 | LENSAR Laser System – fs 3D (LLS-fs 3D) | OOE | Substantially Equivalent | |
| K170576 | LENSAR Laser System - fs 3D (LLS-fs 3D) | OOE | Substantially Equivalent | |
| K152453 | LENSAR Laser System - fs 3D (LLS-fs 3D) | OOE | Substantially Equivalent | |
| K143010 | LENSAR Laser System - fs 3D | OOE | Substantially Equivalent | |
| K123859 | TBD | OOE | Substantially Equivalent | |
| K122829 | LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS | HQC | Substantially Equivalent | |
| K120214 | TBD | OOE | Substantially Equivalent | |
| K112098 | TBD | OOE | Substantially Equivalent | |
| K102727 | LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY | OOE | Substantially Equivalent | |
| K090633 | LENSAR LASER SYSTEM | OOE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009026057 | 3009026057 | LENSAR, Inc | 2800 Discovery Drive, Orlando, FL 32826 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain