Medical Device Manufacturer · US , Walker , MI

Optikem International, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 1982

Recent clearances: SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Optikem International, Inc. Ophthalmic ✕

2 devices

1-2 of 2

Cleared Jun 13, 2007

SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT...

Ophthalmic · 43d

Cleared Sep 30, 1982

LE CASE HARD CONTACT LENS STORAGE CASE

Ophthalmic · 43d