Cleared Special

K222230 - NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health
(FDA 510(k) Clearance)

K222230 · Neuronetics, Inc. · Neurology

Aug 2022

Decision

30d

Days

Class 2

Risk

K222230 is an FDA 510(k) clearance for the NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health, a Transcranial Magnetic Stimulator (Class II — Special Controls, product code OBP), submitted by Neuronetics, Inc. (Malvern, US). The FDA issued a Cleared decision on August 24, 2022, 30 days after receiving the submission on July 25, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5805.

Submission Details

510(k) Number	K222230 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 2022
Decision Date	August 24, 2022
Days to Decision	30 days
Submission Type	Special
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.