PLASTIC OPTICAL LENS M-110

PLASTIC OPTICAL LENS M-110 is an FDA 510(k)-cleared medical device (K834261) manufactured by U-Molde Systems, 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 15, 1984. Regulation: 8.