Smileyscope System (Therapy Mode)

Smileyscope System (Therapy Mode) is an FDA 510(k)-cleared medical device (K230825) manufactured by Smileyscope Holding, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 24, 2023. Regulation: 8.