CRYSTAL CUSTOM TINTED SOFT CONTACT LENS

CRYSTAL CUSTOM TINTED SOFT CONTACT LENS is an FDA 510(k)-cleared medical device (K993489) manufactured by Crystal Reflections, Int., 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 April 13, 2000. Regulation: 8.