UltraClear Fractional Laser System

UltraClear Fractional Laser System is an FDA 510(k)-cleared medical device (K210847) manufactured by Fa International, LP. 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 9, 2021. Regulation: 8.