FLEXUS 2 CO2 SURGICAL LASER SYSTEM

FLEXUS 2 CO2 SURGICAL LASER SYSTEM is an FDA 510(k)-cleared medical device (K850985) manufactured by Intl. Solarium Manufacturer, 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 March 24, 1985. Regulation: 8.