Data / Medical devices / Keratoscope, Ac-Powered
Keratoscope, Ac-Powered (HLQ): 9 FDA-registered makers in 5 countries
9 establishments in 5 countries are registered with the FDA to make Keratoscope, Ac-Powered (product code HLQ, Class 1, 21 CFR 886.1350). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 29 510(k) clearances under this code, the latest on March 9, 2001, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- HLQ
- Device class
- 1
- Regulation
- 886.1350
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| India | 2 |
| Italy | 2 |
| United States | 2 |
| Japan | 2 |
| Germany | 1 |
Makers of Keratoscope, 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 |
|---|---|---|---|---|---|---|---|---|
| Appasamy Associates Private Limited ( Ambattur) | Chennai Tamil Nadu, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Appasamy Associates Private Limited ( Thruvandar Koil) | Mannadipet Commune Puducherry, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C.S.O. S.R.L. | Scandicci Firenze, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gome Optical Lens Company Limited | Yonkers, NY, United States | Specification developer | 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 | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nidek Incorporated | The Colony, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VISIA imaging S.r.l. | San Giovanni Valdarno Arezzo, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WaveLight GmbH | Teltow Brandenburg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 9, 2001. 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.