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CooperVision, Inc.
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AVAIRA (ENFILCON A) CONTACT LENS is an FDA 510(k)-cleared medical device (K113759) manufactured by CooperVision, 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 2, 2012. Regulation: 8.