AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE

AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE is an FDA 510(k)-cleared medical device (K080006) manufactured by Cynosure, 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 27, 2008. Regulation: 8.