CHROMAGEN V3.0 READING AID SOFT CONTACT LENS

CHROMAGEN V3.0 READING AID SOFT CONTACT LENS is an FDA 510(k)-cleared medical device (K012132) manufactured by Cantor & Nissel , 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 May 8, 2002. Regulation: 8.