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Palomar Medical Products, Inc.
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PALOMAR LUX1540 HANDPIECE is an FDA 510(k)-cleared medical device (K061652) manufactured by Palomar Medical Products, 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 February 26, 2007. Regulation: 8.