GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE

GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE is an FDA 510(k)-cleared medical device (K062991) manufactured by Light Bioscience, 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 February 14, 2008. Regulation: 8.