MYC
- Product code
- MYC
- Device name
- Ophthalmoscope, Laser, Scanning
- Device class
- Class 2
- 21 CFR
- 21 CFR 886.1570
- Medical specialty
- Ophthalmic
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 22 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K241931 | 2025-04-22 | Ocusciences, Inc. | OcuMet Beacon (OCUB100) | |
| K243504 | 2025-03-17 | Centervue S.P.A. | MAIA (AHMACME001) |
Official FDA classification page: MYC
Classification and pathway per current FDA publications. Data from openFDA (CC0).