SUNETICS CLINICAL BIO-STIMULATION LASER

SUNETICS CLINICAL BIO-STIMULATION LASER is an FDA 510(k)-cleared medical device (K132646) manufactured by Sunetics International Marketing Group, LLC. 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 December 19, 2013. Regulation: 8.