FDA Product Code MPA: Endoilluminator
Leading manufacturers include Peregrine Surgical, LLC, Alcon Laboratories, Inc. and Nova Eye Inc. (Business Name Nova Eye Medical).
FDA 510(k) Cleared Endoilluminator Devices (Product Code MPA)
About Product Code MPA - Regulatory Context
510(k) Submission Activity
40 total 510(k) submissions under product code MPA since 1995, with 40 receiving FDA clearance (average review time: 128 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under MPA have taken an average of 199 days to reach a decision - up from 125 days historically. Manufacturers should account for longer review timelines in current project planning.
MPA devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →