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

IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS is an FDA 510(k)-cleared medical device (K984523) manufactured by Igel Vision Care Pte , Ltd.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 15, 1999. Regulation: 8.