Data / Medical devices / Refractor, Manual, Non-Powered, Including Phoropter / Japan
FDA-registered makers of Refractor, Manual, Non-Powered, Including Phoropter in Japan: 8 establishments
8 establishments in Japan are registered with the FDA to make Refractor, Manual, Non-Powered, Including Phoropter (product code HKN). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Refractor, Manual, Non-Powered, Including Phoropter
- Product code
- HKN
- Country
- Japan
Makers of Refractor, Manual, Non-Powered, Including Phoropter in Japan
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Inami & Co., Ltd. | Bunkyo Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nidek Co., Ltd. | Gamagori, Aichi, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nidek Co., Ltd. Hamacho Plant | Gamagori, Aichi, Japan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rexxam.co., Ltd. | Takamatsu Kagawa, Japan | Contract manufacturer, 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 | |
| Topcon Yamagata Co., LTD | Yamagata-KEN, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.