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Lenstec, Inc.
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LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES is an FDA 510(k)-cleared medical device (K050638) manufactured by Lenstec, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 30, 2005. Regulation: 8.