Data / Medical devices / Spectacle, Operating (Loupe), Ophthalmic
Spectacle, Operating (Loupe), Ophthalmic (HOH): 12 FDA-registered makers in 7 countries
12 establishments in 7 countries are registered with the FDA to make Spectacle, Operating (Loupe), Ophthalmic (product code HOH, Class 1, 21 CFR 886.4770). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on January 25, 1994, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HOH
- Device class
- 1
- Regulation
- 886.4770
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| India | 3 |
| United States | 2 |
| Germany | 2 |
| South Korea | 2 |
| Japan | 1 |
| China | 1 |
| Australia | 1 |
Makers of Spectacle, Operating (Loupe), 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 |
|---|---|---|---|---|---|---|---|---|
| General Scientific Corp. | Ann Arbor, MI, United States | Manufacturer | 1 | January 25, 1994 | 0 | 0 | 0 | api.fda.gov |
| Akriti Ophthalmic Private Limited | Hyderabad Telangana, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aurora Surgical, LLC | St Petersburg, FL, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carl Zeiss Meditec AG (oberkochen) | OBERKOCHEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Charmant, Inc. | Sabae-City, Fukui-Pref., Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ChoiceTech Korea Co.,Ltd. | Yongin Gyeonggi, South Korea | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dr-Kim Co.,ltd. | Gwangmyeong-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Four E's Scientific Co., Ltd. | GUANGZHOU Guangdong, China | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S Tarun Enterprises | Prayagraj, Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oculus Optikgerate GMBH | WETZLAR Hesse, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scan Optics Pty., Ltd. | THEBARTON, ADELAIDE South Australia, Australia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Speedway | India Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 25, 1994. 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.