Data / Medical devices / Retinoscope, Ac-Powered
Retinoscope, Ac-Powered (HKL): 6 FDA-registered makers in 4 countries
6 establishments in 4 countries are registered with the FDA to make Retinoscope, Ac-Powered (product code HKL, Class 2, 21 CFR 886.1780). 1 of them has a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on July 7, 2000, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HKL
- Device class
- 2
- Regulation
- 886.1780
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| India | 2 |
| United States | 2 |
| United Kingdom | 1 |
| China | 1 |
Makers of Retinoscope, Ac-Powered
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 |
|---|---|---|---|---|---|---|---|---|
| Keeler Ltd. | WINDSOR, BERKSHIRE Windsor and Maidenhead, United Kingdom | Manufacturer | 1 | September 21, 1989 | 0 | 0 | 0 | api.fda.gov |
| Kashmir Surgical Works | AMBALA Haryana, India | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S Tarun Enterprises | Prayagraj, Uttar Pradesh, India | 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 | |
| Xenon Ophthalmics | Jersey City, NJ, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zumax Medical Co, Ltd. | Suzhou,Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 7, 2000. 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.