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Data / Medical devices / Ophthalmic Femtosecond Laser

Ophthalmic Femtosecond Laser (OOE): 19 FDA-registered makers in 5 countries

19 establishments in 5 countries are registered with the FDA to make Ophthalmic Femtosecond Laser (product code OOE, Class 2, 21 CFR 886.4390). 13 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 47 510(k) clearances under this code, the latest on September 24, 2025, and lists 8 recall events (0 Class I). 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.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
OOE
Device class
2
Regulation
886.4390
Medical specialty
Ophthalmic

Makers by country

CountryMakers
United States12
Germany3
Switzerland2
Mexico1
Costa Rica1

Makers of Ophthalmic Femtosecond Laser

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
LENSAR, IncOrlando, FL, United StatesManufacturer13June 9, 2022000api.fda.gov
AMO Manufacturing USA, LLCMilpitas, CA, United StatesManufacturer, Specification developer11April 14, 2023030api.fda.gov
OptiMedica Corp.Milpitas, CA, United StatesManufacturer, Specification developer4September 20, 2016020api.fda.gov
Technolas Perfect Vision GMBHMunchen Bavaria, GermanyExporter to the US, Manufacturer4September 1, 2020000api.fda.gov
Johnson & Johnson Surgical Vision, Inc.Irvine, CA, United StatesManufacturer, Specification developer3September 11, 2014000api.fda.gov
Alcon Research, LLCLake Forest, CA, United StatesSpecification developer2September 24, 2025000api.fda.gov
Alcon Research, LLCIrvine, CA, United StatesManufacturer2September 24, 2025000api.fda.gov
Ziemer Ophthalmic Systems AGPORT Bern, SwitzerlandManufacturer2April 21, 2022000api.fda.gov
Ziemer Opthalmic Systems AGBruegg Bern, SwitzerlandManufacturer2April 21, 2022000api.fda.gov
Alcon Research, LLCHouston, TX, United StatesManufacturer1March 27, 2018000api.fda.gov
Bausch & Lomb IncorporatedSaint Louis, MO, United StatesRemanufacturer1January 16, 2015000api.fda.gov
WAVELIGHT GmbHERLANGEN Bavaria, GermanySpecification developer1September 30, 2014000api.fda.gov
WAVELIGHT GmbHPRESSATH Bavaria, GermanyManufacturer1September 30, 2014000api.fda.gov
AvailMed S.A.De C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
JunoPacific, Inc.Brooklyn Park, MN, United StatesContract manufacturer0000api.fda.gov
Primo Medical Group, IncW Bridgewater, MA, United StatesContract manufacturer0000api.fda.gov
Tecan Cdmo Solutions MH, Corp.Morgan Hill, CA, United StatesContract manufacturer0000api.fda.gov
Vialase Inc.Aliso Viejo, CA, United StatesManufacturer for export0000api.fda.gov
Viant Costa Rica, S.A.Barreal De Heredia, Costa RicaContract manufacturer0000api.fda.gov

Updated September 24, 2025. 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.