RURASOFT 2 FRESHLOOK COLORS; DURASOFT 2 FRESHLOOK LITETINT

RURASOFT 2 FRESHLOOK COLORS; DURASOFT 2 FRESHLOOK LITETINT is an FDA 510(k)-cleared medical device (K962957) 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 September 30, 1996. Regulation: 8.