MYC

Ophthalmoscope, Laser, Scanning

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)

Last three years. Most recent: 2025-04-22.

NumberDecision dateApplicantDevice nameSummary
K2419312025-04-22Ocusciences, Inc.OcuMet Beacon (OCUB100)PDF
K2435042025-03-17Centervue S.P.A.MAIA (AHMACME001)PDF

2 summaries are archived here for direct download.

Official FDA classification page: MYC
Classification and pathway per current FDA publications. Data from openFDA (CC0).