Cleared Traditional

NeuroStar Advanced Therapy System (All previously cleared models)

K231926 · Neuronetics, Inc. · Neurology

Mar 2024

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K231926 is an FDA 510(k) clearance for the NeuroStar Advanced Therapy System (All previously cleared models), a Transcranial Magnetic Stimulator (Class II — Special Controls, product code OBP), submitted by Neuronetics, Inc. (Malvern, US). The FDA issued a Cleared decision on March 22, 2024, 266 days after receiving the submission on June 30, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5805.

Submission Details

510(k) Number	K231926 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2023
Decision Date	March 22, 2024
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OBP — Transcranial Magnetic Stimulator
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5805
Definition	A Transcranial Magnetic Stimulator Is A Device That Delivers Brief Duration, Rapidly Alternating, Or Pulsed, Magnetic Fields To Induce Electrical Currents That Are Directed At Spatially Discrete Regions Of The Cerebral Cortex For The Treatment Of Major Depressive Disorder.