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Sis Ltd., Surgical Instrument Systems
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XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM is an FDA 510(k)-cleared medical device (K082871) manufactured by Sis Ltd., Surgical Instrument Systems. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 8, 2009. Regulation: 8.