NeuroStar Advanced Therapy System (Version 3.7)

NeuroStar Advanced Therapy System (Version 3.7) is an FDA 510(k)-cleared medical device (K230029) manufactured by Neuronetics. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 3, 2023. Regulation: 8.