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Alma Lasers , Ltd.
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ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE is an FDA 510(k)-cleared medical device (K082622) manufactured by Alma Lasers , 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 January 11, 2009. Regulation: 8.