Data / Medical devices / Ophthalmoscope, Laser, Scanning
Ophthalmoscope, Laser, Scanning (MYC): 13 FDA-registered makers in 6 countries
13 establishments in 6 countries are registered with the FDA to make Ophthalmoscope, Laser, Scanning (product code MYC, Class 2, 21 CFR 886.1570). 6 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 23 510(k) clearances under this code, the latest on September 11, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MYC
- Device class
- 2
- Regulation
- 886.1570
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Italy | 3 |
| Japan | 3 |
| United Kingdom | 1 |
| Germany | 1 |
| Austria | 1 |
Makers of Ophthalmoscope, Laser, Scanning
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 |
|---|---|---|---|---|---|---|---|---|
| Centervue | Padova Veneto, Italy | Manufacturer, Specification developer | 6 | March 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Optos Plc | Dunfermline, Fife, United Kingdom | Complaint file establishment, Manufacturer | 3 | January 16, 2015 | 0 | 0 | 0 | api.fda.gov |
| Optos Inc. | Southborough, MA, United States | Manufacturer | 3 | January 16, 2015 | 0 | 0 | 0 | api.fda.gov |
| Kowa Co. Ltd. Chofu | Chofu Tokyo, Japan | Manufacturer | 2 | September 11, 2026 | 0 | 0 | 0 | api.fda.gov |
| Carl Zeiss Meditec Inc | Dublin, CA, United States | Manufacturer | 1 | August 10, 2009 | 0 | 0 | 0 | api.fda.gov |
| Ocusciences, Inc. | Ann Arbor, MI, United States | Manufacturer | 1 | April 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Elemaster Spa | lomagna Lecco, Italy | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heidelberg Engineering GMBH | HEIDELBERG Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mw.fep SPA | San Giovanni in Persiceto Bologna, Italy | Contract 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 | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nidek Incorporated | The Colony, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wild GmbH | Voelkermarkt Karnten, Austria | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 11, 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.