Medical Device Manufacturer · US , New York , NY

Aeye Health, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2022

Total

Cleared

Denied

FDA 510(k) Regulatory Record - Aeye Health, Inc. Ophthalmic ✕

2 devices

1-2 of 2

Linked clinical trials FDA-regulated device evidence

Regulatory consultants 510(k) submission support ecosystem

Hogan Lovells US LLP

A. Stein - Regulatory Affairs Consulting , Ltd.

Regulatory activity signals

510(k) clearance pathway relevance detected

Medical device regulatory intelligence node

Consulting ecosystem involvement present

Clinical validation data available

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 11, 2026