FLEXLENS 55 SOFT (HYDROPHILIC) CONTACT LENS

FLEXLENS 55 SOFT (HYDROPHILIC) CONTACT LENS is an FDA 510(k)-cleared medical device (K950294) manufactured by Flexlens, 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 April 10, 1996. Regulation: 8.