Medical Device Manufacturer · US , Sacramento , CA

Oti Medical, LLC - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1995

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Oti Medical, LLC Ophthalmic ✕

2 devices

1-2 of 2

Cleared May 12, 1995

OTI MODEL 78-60

Ophthalmic · 57d

Cleared Apr 11, 1995

OTI MODEL TLS-60

Ophthalmic · 15d

Data Source

Sourced from the FDA 510(k) public files . 175,972 total devices indexed.

Last updated: Apr 28, 2026