FDA Product Code MYC: Ophthalmoscope, Laser, Scanning
Leading manufacturers include Ocusciences, Inc. and Centervue S.P.A..
FDA 510(k) Cleared Ophthalmoscope, Laser, Scanning Devices (Product Code MYC)
About Product Code MYC - Regulatory Context
510(k) Submission Activity
22 total 510(k) submissions under product code MYC since 2006, with 22 receiving FDA clearance (average review time: 147 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under MYC have taken an average of 210 days to reach a decision - up from 140 days historically. Manufacturers should account for longer review timelines in current project planning.
MYC devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →