PROLITE III TOWER AND PR AND HR HANDPIECE

PROLITE III TOWER AND PR AND HR HANDPIECE is an FDA 510(k)-cleared medical device (K081095) manufactured by Quantel S.A.. 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 December 11, 2008. Regulation: 8.