SKINCLEAR Q-SWITCHED ND:YAG LASER

SKINCLEAR Q-SWITCHED ND:YAG LASER is an FDA 510(k)-cleared medical device (K083272) manufactured by Global USA Distribution, 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 December 15, 2008. Regulation: 8.