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Neuronetics Inc.

Last updated September 17, 2026

Information

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Device	Model / Reference	Registries	Class	Status
NeuroStar TMS Therapy System	K161519	FDA 510(k)	Class II	Active
Neurostar Tms System	DEN070003	FDA 510(k)	Class II	Active
NeuroStar Advanced Therapy	K201158	FDA 510(k)	Class II	Active
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health	K213543	FDA 510(k)	Class II	Active
NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health	K220127	FDA 510(k)	Class II	Active
NeuroStar Advanced Therapy System (Version 3.8)	K233621	FDA 510(k)	Class II	Active
OCD MT Cap (85-00397-000)	K231350	FDA 510(k)	Class II	Active
Neurostar Tms Therapy System	K133408	FDA 510(k)	Class II	Active
NeuroStar Advanced Therapy System (All previously cleared models)	K231926	FDA 510(k)	Class II	Active
Neurostar Tms Therapy System, Model 1.1	K083538	FDA 510(k)	Class II	Active
NeuroStar TMS Therapy System	K160703	FDA 510(k)	Class II	Active
NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health	K222230	FDA 510(k)	Class II	Active
NeuroStar Advanced Therapy System (Version 3.7)	K230029	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 16, 2009	Z-1421-2009	—	terminated	SenStar Treatment Link may have an open circuit that during use with the NeuroStar TMS Therapy system may cause arcing and heat damage to the SenStar and/or treatment coil. Heating of the SenStar during use has a potential risk of minor scalp burn to patients.