Medical Device Manufacturer · US , Malvern , PA

Neuronetics, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2016

Recent clearances: NeuroStar Advanced Therapy System (All previously cleared models), NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health

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8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Neuronetics, Inc. Neurology ✕

8 devices

1-8 of 8

Cleared Mar 22, 2024

NeuroStar Advanced Therapy System (All previously cleared models)

Neurology · 266d

Cleared Aug 24, 2022

NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System,...

Neurology · 30d

Cleared Jul 15, 2022

NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar,...

Neurology · 178d

Cleared May 06, 2022

NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar...

Neurology · 289d

Cleared Dec 10, 2021

NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar,...

Neurology · 32d

Cleared Nov 20, 2020

NeuroStar Advanced Therapy

Neurology · 204d

Cleared Sep 11, 2016

NeuroStar TMS Therapy System

Neurology · 101d

Cleared Jun 10, 2016

NeuroStar TMS Therapy System

Neurology · 88d