Aurolase Therapy, Laser Delivery Device (LDD)

Aurolase Therapy, Laser Delivery Device (LDD) is an FDA 510(k)-cleared medical device (K202953) manufactured by Nanospectra Biosciences, 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 October 2, 2022. Regulation: 8.