FDA Product Code MPA: Endoilluminator

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 declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.

FDA 510(k) Review Time - MPA Product Code

FDA review times for MPA submissions have been consistent, averaging 132 days recently vs 128 days historically.

MPA devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →

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