
Paragon Vision Sciences
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FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES is an FDA 510(k)-cleared medical device (K070637) 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 April 30, 2007. Regulation: 8.