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Johnson & Johnson Vision Care, Inc.
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ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR) is an FDA 510(k)-cleared medical device (K010114) 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 10, 2001. Regulation: 8.