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

IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS is an FDA 510(k)-cleared medical device (K974837) 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 July 5, 1998. Regulation: 8.