MODEL VISULAS 532S LASER WITH THE VITE OPTION

MODEL VISULAS 532S LASER WITH THE VITE OPTION is an FDA 510(k)-cleared medical device (K100035) manufactured by Carl Zeiss Meditec, AG. 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 March 16, 2010. Regulation: 8.