Data / Medical devices / United States / LENSAR, Inc
LENSAR, Inc: FDA-registered device maker in Orlando, FL, United States, 14 510(k) clearances
LENSAR, Inc is registered with the FDA (registration 3009026057) in Orlando, FL, United States. It lists 3 device types. The FDA files 14 510(k) clearances under its listings, the newest dated June 9, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009026057
- Address
- 2800 Discovery Drive Suite 100, Orlando, FL, United States, 32826
- Owner or operator
- LENSAR, Inc (10041040)
- Roles
- Manufacturer
- First device listed
- June 14, 2012
- Registered through
- 2026
- Brand names listed
- ALLY Adaptive Cataract Treatment System, LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY, LENSAR Laser System -fs 3D (LLS-fs 3D), LENSAR Laser System-fs 3D, LENSAR Laser System-fs 3D (LLS-fs 3D), Lensar Laser System - fs 3D (LLS-fs 3D), Lensar Laser System-fs 3D (LLS-fs 3D)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Laser, Ophthalmic | HQF | 2 | Manufacturer | accessdata.fda.gov |
| Ophthalmic Femtosecond Laser | OOE | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Phacofragmentation | HQC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 9, 2022 | K220259 | ALLY Adaptive Cataract Treatment System | OOE | Substantially Equivalent | Lensar, Inc. | accessdata.fda.gov |
| December 21, 2018 | K182795 | LENSAR Laser System - fs 3D (LLS-fs 3D) | OOE | Substantially Equivalent | Lensar, Inc. | accessdata.fda.gov |
| August 9, 2018 | K181430 | LENSAR Laser System - fs 3D (LLS-fs 3D) | OOE | Substantially Equivalent | Lensar, Inc. | accessdata.fda.gov |
| March 2, 2018 | K173346 | LENSAR Laser System - fs 3D (LLS-fs 3D) | OOE | Substantially Equivalent | Lensar, Inc. | accessdata.fda.gov |
| August 10, 2017 | K171337 | LENSAR Laser System fs 3D (LLS-fs 3D) | OOE | Substantially Equivalent | Lensar, Inc. | accessdata.fda.gov |
| May 5, 2017 | K170576 | LENSAR Laser System - fs 3D (LLS-fs 3D) | OOE | Substantially Equivalent | Lensar, Inc. | accessdata.fda.gov |
| October 15, 2015 | K152453 | LENSAR Laser System - fs 3D (LLS-fs 3D) | OOE | Substantially Equivalent | Lensar, Inc. | accessdata.fda.gov |
| March 20, 2015 | K143010 | LENSAR Laser System - fs 3D | OOE | Substantially Equivalent | Lensar, Inc. | accessdata.fda.gov |
| March 27, 2013 | K123859 | TBD | OOE | Substantially Equivalent | Lensar, Inc. | accessdata.fda.gov |
| December 3, 2012 | K122829 | LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS | HQC | Substantially Equivalent | Lensar, Inc. | accessdata.fda.gov |
| June 8, 2012 | K120214 | TBD | OOE | Substantially Equivalent | Lensar, Inc. | accessdata.fda.gov |
| October 19, 2011 | K112098 | TBD | OOE | Substantially Equivalent | Lensar, Inc. | accessdata.fda.gov |
| March 16, 2011 | K102727 | LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY | OOE | Substantially Equivalent | Lensar, Inc. | accessdata.fda.gov |
| May 13, 2010 | K090633 | LENSAR LASER SYSTEM | OOE | Substantially Equivalent | Lensar, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Phacofragmentation
- All makers of Ophthalmic Femtosecond Laser
- All makers of Laser, Ophthalmic
Updated June 9, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.