Cleared Traditional

NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar

K212289 · Neuronetics, Inc. · Neurology

May 2022

Decision

289d

Days

Class 2

Risk

About This 510(k) Submission

K212289 is an FDA 510(k) clearance for the NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar, a Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder (Class II — Special Controls, product code QCI), submitted by Neuronetics, Inc. (Malvern, US). The FDA issued a Cleared decision on May 6, 2022, 289 days after receiving the submission on July 21, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5802.

Submission Details

510(k) Number	K212289 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 21, 2021
Decision Date	May 06, 2022
Days to Decision	289 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	QCI — Transcranial Magnetic Stimulation System For Obsessive-compulsive Disorder
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5802
Definition	External Device That Uses Magnetic Fields To Induce Neural Activity In The Cerebral Cortex To Treat Neurological And Psychiatric Disorders And Conditions. It Is Not Intended For Applying Or Focusing Magnetic Fields Towards Brain Areas Outside Cerebral Cortex (e.g., Cerebellum).