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Lumenis, Inc.
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FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO is an FDA 510(k)-cleared medical device (K060338) 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 March 8, 2006. Regulation: 8.