
Vistakon
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VISTAKON (METHAFILCON A) CONTACT LENSES is an FDA 510(k)-cleared medical device (K010507) manufactured by Vistakon. 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 11, 2001. Regulation: 8.