INCISIVE FAMILY OF INPULSE ND:YAG LASERS

INCISIVE FAMILY OF INPULSE ND:YAG LASERS is an FDA 510(k)-cleared medical device (K083215) manufactured by Incisive, LLC. 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 April 7, 2009. Regulation: 8.