
Johnson & Johnson Vision Care, Inc.
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VISTAKON (GALYFILCON A) SOFT CONTACT LENS is an FDA 510(k)-cleared medical device (K032340) 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 October 15, 2003. Regulation: 8.