Cleared Special

K233621 - NeuroStar Advanced Therapy System (Vers...

K233621 is an FDA 510(k) clearance for NeuroStar Advanced Therapy System (Vers..., manufactured by Neuronetics. The device is a Class 2 Neurology device with product code OBP cleared through the Special 510(k) pathway after a 30-day FDA review.

K233621 · Neuronetics · Neurology device
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Dec 2023
Decision
30d
Days
Class 2
Risk

K233621 is an FDA 510(k) clearance for the NeuroStar Advanced Therapy System (Version 3.8). Classified as Transcranial Magnetic Stimulator (product code OBP), Class II - Special Controls.

Submitted by Neuronetics (Malvern, US). The FDA issued a Cleared decision on December 13, 2023 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5805 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Neuronetics devices

FDA 510(k) Submission Details - K233621

510(k) Number K233621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2023
Decision Date December 13, 2023
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

OBP Device Classification - Class 2, Special Controls

Product Code OBP Transcranial Magnetic Stimulator
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - OBP Transcranial Magnetic Stimulator

All 47
Devices cleared under the same product code (OBP) and FDA review panel - the closest regulatory comparables to K233621.
NeuroStar Advanced Therapy System (All previously cleared models)
K231926 · Neuronetics, Inc. · Mar 2024
ZapStim Controller Application (Z1023)
K233631 · Revital Lab, Inc. · Feb 2024
NQ TMS for MDD (NQv1-MU-01)
K232688 · Neuroqore, Inc. · Dec 2023
Magstim®Horizon® 3.0 TMS Therapy System
K232235 · The Magstim Company , Ltd. · Oct 2023
Ultimate rTMS
K230735 · Brain Ultimate, Inc. · Sep 2023
NeuroStar Advanced Therapy System (Version 3.7)
K230029 · Neuronetics · Apr 2023