Medilas H Laser Fibers

Medilas H Laser Fibers is an FDA 510(k)-cleared medical device (K161771) manufactured by Dornier Medtech America, 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 July 27, 2016. Regulation: 8.