NutraStim Hair Laser Helmet

NutraStim Hair Laser Helmet is an FDA 510(k)-cleared medical device (K160728) manufactured by Nutra Luxe MD, LLC. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 15, 2016. Regulation: 8.