Neuronetics, Inc.

Medical device manufacturer in Malvern, PA.

14510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K231926NeuroStar Advanced Therapy System (All previously cleared models)OBP · Traditional 03/22/2024SE
K233621NeuroStar Advanced Therapy System (Version 3.8)OBP · Special 12/13/2023SE
K231350OCD MT Cap (85-00397-000)QCI · Special 06/08/2023SE
K230029NeuroStar Advanced Therapy System (Version 3.7)OBP · Traditional 04/04/2023SE
K222230NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar…OBP · Special 08/24/2022SE
K220127NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar…OBP · Traditional 07/15/2022SE
K212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy…QCI · Traditional 05/06/2022SE
K213543NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar…OBP · Special 12/10/2021SE
K201158NeuroStar Advanced TherapyOBP · Traditional 11/20/2020SE
K161519NeuroStar TMS Therapy SystemOBP · Traditional 09/11/2016SE
K160703NeuroStar TMS Therapy SystemOBP · Traditional 06/10/2016SE
K133408Neurostar TMS Therapy SystemOBP · Traditional 03/28/2014SE
K130233Neurostar TMS Therapy SystemOBP · Traditional 04/30/2013SE
K083538Neurostar TMS Therapy System, Model 1.1OBP · Special 12/16/2008SE

Recalls

RecallProductInitiated
Z-1421-2009 NeuroStar TMS Therapy System/SenStar Treatment Link. The SenStar Treatment Link is a…SenStar Treatment Link may have an open circuit that during use with the NeuroStar TMS Therapy system may… 03/16/2009Terminated