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Data / Medical devices / Perimeter, Automatic, Ac-Powered

Perimeter, Automatic, Ac-Powered (HPT): 51 FDA-registered makers in 16 countries

51 establishments in 16 countries are registered with the FDA to make Perimeter, Automatic, Ac-Powered (product code HPT, Class 1, 21 CFR 886.1605). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 41 510(k) clearances under this code, the latest on May 27, 2010, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code
HPT
Device class
1
Regulation
886.1605
Medical specialty
Ophthalmic

Makers by country

CountryMakers
United States20
India4
Italy4
China4
Japan4
Australia2
Poland2
Switzerland2
Canada2
Israel1
South Korea1
Mexico1
United Kingdom1
France1
Turkey1
Germany1

Makers of Perimeter, Automatic, 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
Carl Zeiss Meditec IncDublin, CA, United StatesManufacturer, Specification developer1November 24, 1995000api.fda.gov
Konan Medical Usa, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1August 2, 2007000api.fda.gov
Notal Vision Ltd.Tel Aviv, IsraelManufacturer1December 23, 2009000api.fda.gov
Novavision, Inc.Boca Raton, FL, United StatesManufacturer1April 22, 2003000api.fda.gov
Appasamy Associates Private Limited ( Thirubhuvanai))Mannadipet Commune Puducherry, IndiaManufacturer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesManufacturer0000api.fda.gov
CentervuePadova Veneto, ItalyManufacturer, Specification developer0000api.fda.gov
Chongqing Kanghua Ruiming S&T Co., Ltd.Chongqing, ChinaManufacturer0000api.fda.gov
Chongqing SS Medical Equipments Co., LtdChongqing, ChinaManufacturer0000api.fda.gov
Chongqing Sunkingdom Medical Instrument Co.,ltdChongqing, ChinaManufacturer0000api.fda.gov
Crewt Medical Systems, IncChiyoda-ku Tokyo, JapanManufacturer0000api.fda.gov
Eyeonic Pty LimitedCaulfield North Victoria, AustraliaManufacturer0000api.fda.gov
Eyevis Mediworks Private LimitedAhmedabad Gujarat, IndiaManufacturer0000api.fda.gov
Elemaster Spalomagna Lecco, ItalyContract manufacturer0000api.fda.gov
Frey Spolka JawnaPIASECZNO Mazowieckie, PolandContract manufacturer, Manufacturer0000api.fda.gov
G2 Optic Co., LtdGUNPO-SI Gyeonggi, South KoreaManufacturer0000api.fda.gov
Haag-Streit AGKOENIZ Bern, SwitzerlandManufacturer0000api.fda.gov
Heru, Inc.Miami, FL, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Jaltek Systems LimitedLuton, United KingdomContract manufacturer0000api.fda.gov
Kowa Co. Ltd. ChofuChofu Tokyo, JapanManufacturer0000api.fda.gov
KYS Vision, Inc.Elko, NV, United StatesComplaint file establishment, Specification developer0000api.fda.gov
M&S TechnologiesNiles, IL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
M&S TechnologiesThayne, WY, United StatesManufacturer0000api.fda.gov
M/S Tarun EnterprisesPrayagraj, Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Main Meditech Co., LtdChongqing, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Medmont International Pty LtdNunawading Victoria, AustraliaExporter to the US, Manufacturer0000api.fda.gov
Medneuroptek Inc.Johns Creek, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Metrovision SASPerenchies Nord, FranceManufacturer0000api.fda.gov
Micro Medical Devices, Inc.Calabasas, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Morgan Newton CompanyPlano, TX, United StatesContract manufacturer0000api.fda.gov
Mw.fep SPASan Giovanni in Persiceto Bologna, ItalyContract manufacturer0000api.fda.gov
Nidek Co., Ltd.Gamagori, Aichi, JapanSpecification developer0000api.fda.gov
Nidek Co., Ltd. Hamacho PlantGamagori, Aichi, JapanManufacturer0000api.fda.gov
Nidek IncorporatedThe Colony, TX, United StatesManufacturer0000api.fda.gov
Oculera Saglik Teknolojileri A.S.Ankara, TurkeyManufacturer0000api.fda.gov
Oculus Optikgerate GMBHWETZLAR Hesse, GermanyManufacturer0000api.fda.gov
Olleyes, Inc.Summit, NJ, United StatesManufacturer0000api.fda.gov
OPTOPOLTechnology Sp. z o.o.Zawiercie Slaskie, PolandManufacturer0000api.fda.gov
Peripherex Inc.Menlo Park, CA, United StatesManufacturer0000api.fda.gov
Perivision S.A.Epalinges Vaud, SwitzerlandExporter to the US, Manufacturer0000api.fda.gov
Ray Vision Inc.Lake Forest, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Remidio Innovative Solutions Private LimitedBengaluru Karnataka, IndiaManufacturer0000api.fda.gov
Retinalogik Inc.Calgary Alberta, CanadaManufacturer0000api.fda.gov
RMF Design and Manufacturing Inc.Mississauga Ontario, CanadaContract manufacturer0000api.fda.gov
RadiusXR Inc.Pleasanton, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Sight Intelligence Engineering CorporationFairfax, VA, United StatesManufacturer0000api.fda.gov
VIRTUAL FIELD, IncBrooklyn, NY, United StatesManufacturer0000api.fda.gov
Virtual Vision HealthMiami, FL, United StatesManufacturer0000api.fda.gov
VISIA imaging S.r.l.San Giovanni Valdarno Arezzo, ItalyManufacturer0000api.fda.gov
Vivid VisionSan Francisco, CA, United StatesSpecification developer0000api.fda.gov

Updated May 27, 2010. 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.