SPECIALTY TINT SOFT CONTACT LENS

SPECIALTY TINT SOFT CONTACT LENS is an FDA 510(k)-cleared medical device (K003079) manufactured by Specialty Tint. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 20, 2000. Regulation: 8.