
Paragon Vision Sciences
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PAFLUFOCON C AND E DAILY CONTACT LENS is an FDA 510(k)-cleared medical device (K002845) manufactured by Paragon Vision Sciences. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 7, 2000. Regulation: 8.