Medical Device Manufacturer · US , Hialeah , FL

Optical Systems Intl., Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1985

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Optical Systems Intl., Inc. Ophthalmic ✕

2 devices

1-2 of 2

Cleared Nov 12, 1985

THE ULTRA-MATE LENS

Ophthalmic · 26d

Cleared Jul 31, 1985

ULTRATHIN/SP LENS

Ophthalmic · 294d