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Data / Medical devices / Keratome, Ac-Powered

Keratome, Ac-Powered (HNO): 21 FDA-registered makers in 5 countries

21 establishments in 5 countries are registered with the FDA to make Keratome, Ac-Powered (product code HNO, Class 1, 21 CFR 886.4370). 6 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 83 510(k) clearances under this code, the latest on April 13, 2018, and lists 6 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
HNO
Device class
1
Regulation
886.4370
Medical specialty
Ophthalmic

Makers by country

CountryMakers
United States10
Germany5
France3
Switzerland2
Mexico1

Makers of Keratome, Ac-Powered

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
Med-Logics, Inc.Athens, TX, United StatesManufacturer9January 13, 2004010api.fda.gov
Moria S.A.MASSY Hauts-de-Seine, FranceSpecification developer5October 26, 2017000api.fda.gov
Microspecialties LLCMiddletown, CT, United StatesManufacturer, Manufacturer for export5May 25, 2004000api.fda.gov
Moria S.ABourbon l'Archambault Allier, FranceExporter to the US, Manufacturer3March 25, 2005000api.fda.gov
Bausch & Lomb IncorporatedSaint Louis, MO, United StatesRemanufacturer2March 22, 2004000api.fda.gov
Technolas Perfect Vision GMBHMunchen Bavaria, GermanyExporter to the US, Manufacturer2March 22, 2004000api.fda.gov
A7 Precision Machine Technology Inc.Doral, FL, United StatesContract manufacturer0000api.fda.gov
AMO Manufacturing USA, LLCMilpitas, CA, United StatesManufacturer, Specification developer0010api.fda.gov
Alcon Research, LLCLake Forest, CA, United StatesSpecification developer0000api.fda.gov
Alcon Research, LLCIrvine, CA, United StatesManufacturer0000api.fda.gov
Alcon Research, LLCHouston, TX, United StatesManufacturer0000api.fda.gov
AvailMed S.A.De C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Carl Zeiss Meditec AG (jena)JENA Thuringia, GermanySpecification developer0000api.fda.gov
Carl Zeiss Meditec AG (Jena)Jena Thuringia, GermanyManufacturer0000api.fda.gov
Johnson & Johnson Surgical Vision, Inc.Irvine, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Metal ProcessMontevrain Ile-de-France, FranceContract manufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.fda.gov
WAVELIGHT GmbHERLANGEN Bavaria, GermanySpecification developer0000api.fda.gov
WAVELIGHT GmbHPRESSATH Bavaria, GermanyManufacturer0010api.fda.gov
Ziemer Ophthalmic Systems AGPORT Bern, SwitzerlandManufacturer0000api.fda.gov
Ziemer Opthalmic Systems AGBruegg Bern, SwitzerlandManufacturer0000api.fda.gov

Updated April 13, 2018. 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.