Medical Device Manufacturer · US , Englewood , CO

Flexlens, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1996

Recent clearances: CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A), FLEXLENS, FLEXLENS(METHAFILCON A)

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

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

4 devices

1-4 of 4

Cleared Apr 02, 1997

CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A)

Ophthalmic · 65d

Cleared Oct 01, 1996

Ophthalmic · 134d

Cleared Oct 01, 1996

FLEXLENS(METHAFILCON A)

Ophthalmic · 132d

Cleared Apr 11, 1996

FLEXLENS 55 SOFT (HYDROPHILIC) CONTACT LENS

Ophthalmic · 442d