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Unilens Corp., USA
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AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS is an FDA 510(k)-cleared medical device (K002408) manufactured by Unilens Corp., USA. 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 16, 2000. Regulation: 8.