FLEXLENS, FLEXLENS TORIC

FLEXLENS, FLEXLENS TORIC is an FDA 510(k)-cleared medical device (K973192) manufactured by Specialty Ultravision, 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 November 19, 1997. Regulation: 8.