UltraLase Flexible CO2 Laser Waveguide

UltraLase Flexible CO2 Laser Waveguide is an FDA 510(k)-cleared medical device (K211761) manufactured by W & R Investments, LLC Dba Laser Engineering. 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 July 29, 2021. Regulation: 8.