NeuroStar Advanced Therapy System (All previously cleared models)

NeuroStar Advanced Therapy System (All previously cleared models) is an FDA 510(k)-cleared medical device (K231926) manufactured by Neuronetics, 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 March 21, 2024. Regulation: 8.