ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA

ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA is an FDA 510(k)-cleared medical device (K141670) 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 September 17, 2014. Regulation: 8.