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Data / Medical devices / Laser, Ophthalmic / United States

FDA-registered makers of Laser, Ophthalmic in the United States: 22 establishments

22 establishments in the United States are registered with the FDA to make Laser, Ophthalmic (product code HQF). 15 have a 510(k) clearance or PMA approval on file and 8 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.

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Device
Laser, Ophthalmic
Product code
HQF
Country
United States

Makers of Laser, Ophthalmic in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Iridex CorporationSan Jose, CA, United StatesManufacturer14February 23, 2023000api.fda.gov
Iridex CorporationMountain View, CA, United StatesManufacturer14February 23, 2023020api.fda.gov
Nidek IncorporatedThe Colony, TX, United StatesManufacturer5December 7, 2020040api.fda.gov
Norlase INCRedwood City, CA, United StatesComplaint file establishment, Manufacturer4October 25, 2024000api.fda.gov
Alcon Research, LLCLake Forest, CA, United StatesSpecification developer3April 7, 2026000api.fda.gov
Alcon Research, LLCIrvine, CA, United StatesContract manufacturer, Manufacturer3April 7, 2026010api.fda.gov
Bausch & Lomb IncorporatedRochester, NY, United StatesComplaint file establishment, Specification developer2June 21, 2006010api.fda.gov
Katalyst Surgical, LLCChesterfield, MO, United StatesComplaint file establishment, Manufacturer, Specification developer2September 15, 2014000api.fda.gov
Ophthalmed LLCRoswell, GA, United StatesManufacturer2June 25, 2015000api.fda.gov
Peregrine Surgical, LLC.New Britain, PA, United StatesContract manufacturer, Manufacturer2June 21, 2006010api.fda.gov
Bausch & Lomb IncorporatedSaint Louis, MO, United StatesManufacturer1February 10, 2004010api.fda.gov
Beaver-Visitec International, IncLittle Silver, NJ, United StatesManufacturer1May 28, 1991000api.fda.gov
Beaver-Visitec International, Inc.Waltham, MA, United StatesComplaint file establishment, Specification developer1April 3, 2025010api.fda.gov
Lumenis Be Inc.Salt Lake City, UT, United StatesManufacturer1July 15, 2022020api.fda.gov
Omni-Guide Holdings, Inc.Billerica, MA, United StatesManufacturer1May 9, 2005000api.fda.gov
Alcon Research, LLCHouston, TX, United StatesManufacturer0000api.fda.gov
Avedro, A Glaukos CompanyBurlington, MA, United StatesManufacturer for export0000api.fda.gov
Excel-Lens, Inc.Tracy, CA, United StatesManufacturer for export0000api.fda.gov
LENSAR, IncOrlando, FL, United StatesManufacturer0000api.fda.gov
Linemaster Switch Corp.Woodstock, CT, United StatesContract manufacturer0000api.fda.gov
Oncore Manufacturing, LLC dba NEOTechFremont, CA, United StatesContract manufacturer0000api.fda.gov
Precision Optics Corp.Gardner, MA, United StatesContract manufacturer0000api.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.