ProFlex CO2 Laser Fiber

ProFlex CO2 Laser Fiber is an FDA 510(k)-cleared medical device (K203799) manufactured by Innovaquartz, 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 September 19, 2021. Regulation: 8.