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Lumenis, Inc.
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SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS is an FDA 510(k)-cleared medical device (K081704) manufactured by Lumenis, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 10, 2008. Regulation: 8.