DuraLazeTM HoLEP Laser Fiber

DuraLazeTM HoLEP Laser Fiber is an FDA 510(k)-cleared medical device (K153124) manufactured by Medkey, 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 July 25, 2016. Regulation: 8.