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
| Country | Makers |
|---|---|
| India | 9 |
| Japan | 8 |
| United States | 7 |
| China | 7 |
| Italy | 1 |
| United Kingdom | 1 |
| Denmark | 1 |
| Thailand | 1 |
| Germany | 1 |
| Hong Kong | 1 |
| Taiwan | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Akriti Ophthalmic Private Limited | Hyderabad Telangana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ama Optics, Inc. | Miami Beach, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alcon Research, LLC | Duluth, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Charmant, Inc. | Sabae-City, Fukui-Pref., Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elevate Solutions Group, LLC | Austell, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epsilon Eye Care Pvt., Ltd. | MUMBAI Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Evo Di Bridda Massimo | SEDICO Belluno, Italy | Complaint file establishment, Contract manufacturer, Contract sterilizer, Exporter to the US, Foreign private label distributor, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eyeque Corporation | Newark, CA, United States | Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gino Optical (shanghai) Co., Ltd. | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Greens Surgicals Private Limited | Vadodara Gujarat, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gulden Ophthalmics | Elkins Park, PA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inami & Co., Ltd. | Bunkyo Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Indo-German Surgical Corporation | Mumbai Maharashtra, India | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Iscon Surgicals, Ltd. | JODHPUR Rajasthan, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kdans Surgical Private Limited | GANDHINAGAR Gujarat, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Keeler Ltd. | WINDSOR, BERKSHIRE Windsor and Maidenhead, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | LIANYUNGANG Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lindberg A/S | AABYHOJ Midtjylland, Denmark | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mirazo Co.,ltd. | Thailand Chon Buri, Thailand | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Narang Medical, Ltd. | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Ming Sing Optical R&D Co., Ltd. | Ningbo Zhejiang, China | Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oculus Optikgerate GMBH | WETZLAR Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Optica Fukui, Inc. | Sabae City, Fukui Pref., Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paul Instruments (india) | CALCUTTA West Bengal, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polette Limited | Hong Kong, Hong Kong | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Vision | Woodstock, IL, United States | Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ray Vision Inc. | Lake Forest, CA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Seki Gankyo Seisakusho K.K | Sabae city Fukui, Japan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Canton Optics Equipment Co., Ltd. | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Link Instruments Co.,ltd | Changzhou City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Speedway | India Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Takagi Seiko Co., Ltd. | NAKANO-SHI Nagano, Japan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Topcon Corp. | Tokyo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Towa Medical Instruments Co.,ltd. | Nakano-shi Nagano, Japan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taiyuan North China Xinyuan Tech. Center (Co., LTD.) | TAIYUAN Shaanxi, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tanaka Production Co., Ltd. | Sabae, Fukui, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Well Sun Optical Technology Limited. | Tainan, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuxi Zontai Int'l Corporation Ltd. | WUXI Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.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.