CORTEX CO2 / ER:YAG LASER SYSTEM

CORTEX CO2 / ER:YAG LASER SYSTEM is an FDA 510(k)-cleared medical device (K110897) manufactured by Sandstone Medical Technologies, 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 June 30, 2011. Regulation: 8.