COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS

COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS is an FDA 510(k)-cleared medical device (K990815) manufactured by Colorsoft Laboratories Corp.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 2, 1999. Regulation: 8.