ACUVUE OASYS (senofilcon A) with Photochromic Additive

ACUVUE OASYS (senofilcon A) with Photochromic Additive is an FDA 510(k)-cleared medical device (K180299) 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 April 9, 2018. Regulation: 8.