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Neuronetics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K231926NeuroStar Advanced Therapy System (All previously cleared models)March 22, 2024
K233621NeuroStar Advanced Therapy System (Version 3.8)December 13, 2023
K231350OCD MT Cap (85-00397-000)June 8, 2023
K230029NeuroStar Advanced Therapy System (Version 3.7)April 4, 2023
K222230NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced TheraAugust 24, 2022
K220127NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced TheraJuly 15, 2022
K212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroMay 6, 2022
K213543NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced TheraDecember 10, 2021
K201158NeuroStar Advanced TherapyNovember 20, 2020
K161519NeuroStar TMS Therapy SystemSeptember 11, 2016
K160703NeuroStar TMS Therapy SystemJune 10, 2016
K133408NEUROSTAR TMS THERAPY SYSTEMMarch 28, 2014
K130233NEUROSTAR TMS THERAPY SYSTEMApril 30, 2013
K083538NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1December 16, 2008
DEN070003NEUROSTAR TMS SYSTEMOctober 7, 2008