Data / Medical devices / Ophthalmic Femtosecond Laser / United States
FDA-registered makers of Ophthalmic Femtosecond Laser in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Ophthalmic Femtosecond Laser (product code OOE). 8 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Ophthalmic Femtosecond Laser
- Product code
- OOE
- Country
- United States
Makers of Ophthalmic Femtosecond Laser in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| LENSAR, Inc | Orlando, FL, United States | Manufacturer | 13 | June 9, 2022 | 0 | 0 | 0 | api.fda.gov |
| AMO Manufacturing USA, LLC | Milpitas, CA, United States | Manufacturer, Specification developer | 11 | April 14, 2023 | 0 | 3 | 0 | api.fda.gov |
| OptiMedica Corp. | Milpitas, CA, United States | Manufacturer, Specification developer | 4 | September 20, 2016 | 0 | 2 | 0 | api.fda.gov |
| Johnson & Johnson Surgical Vision, Inc. | Irvine, CA, United States | Manufacturer, Specification developer | 3 | September 11, 2014 | 0 | 0 | 0 | api.fda.gov |
| Alcon Research, LLC | Lake Forest, CA, United States | Specification developer | 2 | September 24, 2025 | 0 | 0 | 0 | api.fda.gov |
| Alcon Research, LLC | Irvine, CA, United States | Manufacturer | 2 | September 24, 2025 | 0 | 0 | 0 | api.fda.gov |
| Alcon Research, LLC | Houston, TX, United States | Manufacturer | 1 | March 27, 2018 | 0 | 0 | 0 | api.fda.gov |
| Bausch & Lomb Incorporated | Saint Louis, MO, United States | Remanufacturer | 1 | January 16, 2015 | 0 | 0 | 0 | api.fda.gov |
| JunoPacific, Inc. | Brooklyn Park, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, Inc | W Bridgewater, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecan Cdmo Solutions MH, Corp. | Morgan Hill, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vialase Inc. | Aliso Viejo, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.