AURA DYE LASER SYSTEM (ADLS)

AURA DYE LASER SYSTEM (ADLS) is an FDA 510(k)-cleared medical device (K984424) manufactured by Laserscope. 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 March 4, 1999. Regulation: 8.