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Acculaser, Inc.
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ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE is an FDA 510(k)-cleared medical device (K020657) manufactured by Acculaser, Inc.. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 28, 2002. Regulation: 8.