
X-Cel Contacts, Inc.
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DEFINITIVE, FLEXLENS - SILICONE HYDROGEL is an FDA 510(k)-cleared medical device (K100443) manufactured by X-Cel Contacts, 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 27, 2010. Regulation: 8.