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Data / Medical devices / Photocoagulator And Accessories

Photocoagulator And Accessories (HQB): 15 FDA-registered makers in 5 countries

15 establishments in 5 countries are registered with the FDA to make Photocoagulator And Accessories (product code HQB, Class 2, 21 CFR 886.4690). 12 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 30 510(k) clearances under this code, the latest on November 3, 2022, and lists 4 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
HQB
Device class
2
Regulation
886.4690
Medical specialty
Ophthalmic

Makers by country

CountryMakers
United States10
Japan2
Indonesia1
Netherlands1
Mexico1

Makers of Photocoagulator And Accessories

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
Synergetics, Inc.O Fallon, MO, United StatesManufacturer4April 23, 2012010api.fda.gov
Peregrine Surgical, LLC.New Britain, PA, United StatesManufacturer3November 14, 2013000api.fda.gov
Bausch & Lomb IncorporatedRochester, NY, United StatesComplaint file establishment, Specification developer2June 26, 2013000api.fda.gov
Nidek Co., Ltd.Gamagori, Aichi, JapanSpecification developer2July 27, 2011000api.fda.gov
Nidek Co., Ltd. Hamacho PlantGamagori, Aichi, JapanManufacturer2July 27, 2011000api.fda.gov
Nidek IncorporatedThe Colony, TX, United StatesManufacturer2July 27, 2011000api.fda.gov
Vortex Surgical, Inc.Saint Charles, MO, United StatesManufacturer2November 3, 2022020api.fda.gov
Alcon Research, LLCSinking Spring, PA, United StatesManufacturer1October 17, 2011000api.fda.gov
Alcon Research, LLCLake Forest, CA, United StatesSpecification developer1October 17, 2011000api.fda.gov
Alcon Research, LLCIrvine, CA, United StatesManufacturer1October 17, 2011000api.fda.gov
PT. Ciba Vision BatamBATAM ISLAND Riau, IndonesiaManufacturer1October 17, 2011000api.fda.gov
Vitreq BVVierpolders Zuid-Holland, NetherlandsManufacturer1May 1, 2019000api.fda.gov
HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de RL de C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Katalyst Surgical, LLCChesterfield, MO, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Ophthalmed LLCRoswell, GA, United StatesManufacturer0000api.fda.gov

Updated November 3, 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.