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Data / Medical devices / Frame, Trial, Ophthalmic

Frame, Trial, Ophthalmic (HPA): 38 FDA-registered makers in 11 countries

38 establishments in 11 countries are registered with the FDA to make Frame, Trial, Ophthalmic (product code HPA, Class 1, 21 CFR 886.1415). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 5 510(k) clearances under this code, the latest on July 31, 1985, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
HPA
Device class
1
Regulation
886.1415
Medical specialty
Ophthalmic

Makers by country

CountryMakers
India9
Japan8
United States7
China7
Italy1
United Kingdom1
Denmark1
Thailand1
Germany1
Hong Kong1
Taiwan1

Makers of Frame, Trial, Ophthalmic

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
Akriti Ophthalmic Private LimitedHyderabad Telangana, IndiaManufacturer0000api.fda.gov
Ama Optics, Inc.Miami Beach, FL, United StatesManufacturer0000api.fda.gov
Alcon Research, LLCDuluth, GA, United StatesSpecification developer0000api.fda.gov
Charmant, Inc.Sabae-City, Fukui-Pref., JapanManufacturer0000api.fda.gov
Elevate Solutions Group, LLCAustell, GA, United StatesContract manufacturer0000api.fda.gov
Epsilon Eye Care Pvt., Ltd.MUMBAI Maharashtra, IndiaManufacturer0000api.fda.gov
Evo Di Bridda MassimoSEDICO Belluno, ItalyComplaint file establishment, Contract manufacturer, Contract sterilizer, Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer0000api.fda.gov
Eyeque CorporationNewark, CA, United StatesManufacturer, Remanufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Gino Optical (shanghai) Co., Ltd.Shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Greens Surgicals Private LimitedVadodara Gujarat, IndiaManufacturer0000api.fda.gov
Gulden OphthalmicsElkins Park, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
Inami & Co., Ltd.Bunkyo Tokyo, JapanManufacturer0000api.fda.gov
Indo-German Surgical CorporationMumbai Maharashtra, IndiaExporter to the US, Manufacturer0000api.fda.gov
Iscon Surgicals, Ltd.JODHPUR Rajasthan, IndiaManufacturer0000api.fda.gov
Kdans Surgical Private LimitedGANDHINAGAR Gujarat, IndiaContract manufacturer0000api.fda.gov
Keeler Ltd.WINDSOR, BERKSHIRE Windsor and Maidenhead, United KingdomManufacturer0000api.fda.gov
Lianyungang Tiannuo Optical Instrument Co., Ltd.LIANYUNGANG Jiangsu, ChinaManufacturer0000api.fda.gov
Lindberg A/SAABYHOJ Midtjylland, DenmarkManufacturer0000api.fda.gov
Mirazo Co.,ltd.Thailand Chon Buri, ThailandExporter to the US, Manufacturer0000api.fda.gov
Narang Medical, Ltd.New Delhi, IndiaManufacturer0000api.fda.gov
Ningbo Ming Sing Optical R&D Co., Ltd.Ningbo Zhejiang, ChinaExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Oculus Optikgerate GMBHWETZLAR Hesse, GermanyManufacturer0000api.fda.gov
Optica Fukui, Inc.Sabae City, Fukui Pref., JapanManufacturer0000api.fda.gov
Paul Instruments (india)CALCUTTA West Bengal, IndiaManufacturer0000api.fda.gov
Polette LimitedHong Kong, Hong KongContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Precision VisionWoodstock, IL, United StatesRemanufacturer, Repackager or relabeler0000api.fda.gov
Ray Vision Inc.Lake Forest, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Seki Gankyo Seisakusho K.KSabae city Fukui, JapanExporter to the US, Manufacturer0000api.fda.gov
Shanghai Canton Optics Equipment Co., Ltd.Shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Link Instruments Co.,ltdChangzhou City Jiangsu, ChinaManufacturer0000api.fda.gov
SpeedwayIndia Delhi, IndiaManufacturer0000api.fda.gov
Takagi Seiko Co., Ltd.NAKANO-SHI Nagano, JapanExporter to the US, Manufacturer0000api.fda.gov
Topcon Corp.Tokyo, JapanSpecification developer0000api.fda.gov
Towa Medical Instruments Co.,ltd.Nakano-shi Nagano, JapanContract manufacturer, Manufacturer0000api.fda.gov
Taiyuan North China Xinyuan Tech. Center (Co., LTD.)TAIYUAN Shaanxi, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Tanaka Production Co., Ltd.Sabae, Fukui, JapanManufacturer0000api.fda.gov
Well Sun Optical Technology Limited.Tainan, TaiwanManufacturer0000api.fda.gov
Wuxi Zontai Int'l Corporation Ltd.WUXI Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov

Updated July 31, 1985. 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.