Data / Medical devices / Set, Lens, Trial, Ophthalmic
Set, Lens, Trial, Ophthalmic (HPC): 32 FDA-registered makers in 6 countries
32 establishments in 6 countries are registered with the FDA to make Set, Lens, Trial, Ophthalmic (product code HPC, Class 1, 21 CFR 886.1405). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on July 19, 1995, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HPC
- Device class
- 1
- Regulation
- 886.1405
- Medical specialty
- Ophthalmic
Makers by country
Makers of Set, Lens, 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 | |
| Apothecaries Sundries MFG Pvt Ltd | GURUGRAM Haryana, India | Manufacturer, Repackager or relabeler | 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 | |
| Danyang New Hope Medical Equipment Co., Ltd | Danyang Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Epsilon Eye Care Pvt., Ltd. | MUMBAI Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fresnel Prism & Lens Co. | Bloomington, MN, United States | Manufacturer, 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 | |
| IKETANI Co., Ltd. | Kiso-gun, Nagano-KEN, Japan | Contract manufacturer | 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 | |
| Kdans Surgical Private Limited | GANDHINAGAR Gujarat, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Langfang Far East Prosperous Optical Instrument Co.,ltd. | Langfang Hebei, China | Contract manufacturer, 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 | |
| M/S Tarun Enterprises | Prayagraj, Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Narang Medical, Ltd. | New Delhi, India | Manufacturer | 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 | |
| Ray Vision Inc. | Lake Forest, CA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rexxam.co., Ltd. | Takamatsu Kagawa, Japan | 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 | |
| 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 | |
| Update Optical Manufacturer Limited | Longgang District, Shenzhen City Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wenzhou Hala Trade Co.ltd | Wenzhuo Zhejiang, China | Exporter to the US, 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 19, 1995. 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.