DURASOFT FRESHLOOK UV COLORS; DURASOFT 3 FRESHLOOK UV LITE TINT

DURASOFT FRESHLOOK UV COLORS; DURASOFT 3 FRESHLOOK UV LITE TINT is an FDA 510(k)-cleared medical device (K954603) manufactured by Wesley Jessen 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 January 3, 1996. Regulation: 8.