SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS

SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS is an FDA 510(k)-cleared medical device (K991995) manufactured by Softchrome, 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 August 26, 1999. Regulation: 8.