Novilase Laser Therapy System, Model LTS-2

Novilase Laser Therapy System, Model LTS-2 is an FDA 510(k)-cleared medical device (K160392) manufactured by Novian Health, 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 February 25, 2016. Regulation: 8.