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Lumenis, Ltd.
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LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE. is an FDA 510(k)-cleared medical device (K060448) manufactured by Lumenis, Ltd.. 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 July 5, 2006. Regulation: 8.