Medical Device Manufacturer · US , Tracy , CA

Igel Vision Care Pte , Ltd. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1998

Recent clearances: IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS, IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Igel Vision Care Pte , Ltd. Ophthalmic ✕

4 devices

1-4 of 4

Cleared Sep 04, 2002

IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

Ophthalmic · 86d

Cleared Jun 04, 2002

IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL...

Ophthalmic · 81d

Cleared Feb 16, 1999

IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS

Ophthalmic · 57d

Cleared Jul 06, 1998

IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS

Ophthalmic · 194d