Cleared Special

K213543 - NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health
(FDA 510(k) Clearance)

K213543 · Neuronetics, Inc. · Neurology
Dec 2021
Decision
32d
Days
Class 2
Risk

K213543 is an FDA 510(k) clearance for the NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy 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 December 10, 2021, 32 days after receiving the submission on November 8, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5805.

Submission Details

510(k) Number K213543 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2021
Decision Date December 10, 2021
Days to Decision 32 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.