Optain Health, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Optain Health, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Resolve Fundus Camera
1
Total
1
Cleared
0
Denied
Optain Health, Inc. has 1 FDA 510(k) cleared medical devices. Based in New York, US.
Latest FDA clearance: Apr 2025. Active since 2025. Primary specialty: Ophthalmic.
Browse the FDA 510(k) cleared devices submitted by Optain Health, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Oconnell Regulatory Consultants, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Optain Health, Inc.
1 devices