METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR is an FDA 510(k)-cleared medical device (K980218) manufactured by Biocompatibles Eyewear, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 22, 1998. Regulation: 8.