VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY)

VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) is an FDA 510(k)-cleared medical device (K062614) manufactured by Johnson & Johnson Vision Care, 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 October 31, 2006. Regulation: 8.