MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE

MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE is an FDA 510(k)-cleared medical device (K080530) manufactured by Cutera, 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 August 14, 2008. Regulation: 8.