FDA.reportPublic FDA data

NeuroStar Advanced Therapy System

Primary DI
00850005944812
Brand
NeuroStar Advanced Therapy System
Company
NEURONETICS, INC.
Model
Version 3.6
Catalog number
81-03315-00R
Device description
NeuroStar Advanced Therapy System, recertified
Published
2025-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OBPTranscranial Magnetic Stimulator
QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBPTranscranial Magnetic StimulatorNeurology2
QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive DisorderNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201158000
K212289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201158000NeuroStar Advanced TherapyNeuronetics, Inc.2020-11-20OBP
K212289000NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStarNeuronetics, Inc.2022-05-06QCI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005944812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005944812008500059448128500059448120850005944812

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic neural stimulation systemAn assembly of electrically-powered devices intended for the treatment and/or diagnosis of neurological, psychiatric and/or cognitive conditions (e.g., Alzheimer's disease, major depressive disorder, pain) through noninvasive magnetic stimulation of the brain and/or peripheral nerves. It consists of an electromagnet with a control unit intended to produce electromagnetic field pulses to induce neurological electrical activity, and a patient chair; types intended for transcranial magnetic stimulation (TMS) may include cognitive training tools.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-600-7555customersupport@neurostar.com

Regulatory Flags#

DUNS number
134960348
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005944935NeuroStar Headrest81-72026-00R2025-12-15
00850005944881NeuroStar Head Support System, Domestic81-07836-00U2025-12-09
00850005944898NeuroStar Head Support System, Domestic81-04836-00U2025-12-09
00850005944911NeuroStar Headrest81-72026-00U2025-12-09
00850005944928D-Tect MT Accessory81-00241-00U2025-12-09
00850005944843NeuroStar Advanced Therapy SystemVersion 3.X81-02315-00U2025-06-24
00850005944850NeuroStar Advanced Therapy SystemVersion 3.681-03315-00U2025-06-24
00850005944867NeuroStar Advanced Therapy SystemVersion 3.781-04315-00U2025-06-24
00850005944874NeuroStar Advanced Therapy SystemVersion 3.881-05315-00U2025-06-24
00850005944775NeuroStar Head Support System, Domestic81-07836-0002025-06-24
00850005944829NeuroStar Advanced Therapy SystemVersion 3.781-04315-00R2025-05-08
00850005944836NeuroStar Advanced Therapy SystemVersion 3.881-05315-00R2025-05-08
00869378000117NeuroStar TMS Therapy SystemNeuroStar 3.0 US81-02315-0002016-09-20
00850005944638SenStar Treatment Link81-70100-0002024-08-02
10850005944635SenStar Treatment Link81-70100-0002024-08-02
00850005944652SenStar Connect Treatment Link81-71100-1002024-08-02
00850005944225SenStar Treatment Link81-70000-0002022-10-05
00850005944041Arm Support Cushion, Gray87-00021-1002024-02-02
00850005944164Wedge Cushion, Gray87-00022-1002024-02-02
00850005944171Head Cushion Insert Set, Gray87-00657-1002024-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290110537111Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-05-07
07290110537135Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-05-07
07290110538279Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-05-07
07290110538286Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-05-07
07290110538286Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-05-07
04260526050118Apollo TMS ProMAG & More GmbHOBP2026-04-09
04260526050118Apollo TMS ProMAG & More GmbHQCI2026-04-09
07290110530136Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110530167Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110530167Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-03-14
07290110533083Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110533090Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110533106Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110533113Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110537234Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110538026Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110538040Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-03-14
07290110538040Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110538057Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110538064Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-03-14
07290110538064Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
07290110538248Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDQCI2026-03-14
07290110538248Deep Transcranial Magnetic Stimulation (DTMS) SystemBRAINSWAY LTDOBP2026-03-14
04650075333273CloudTMS EdgeNEUROSOFT, OOOOBP2026-01-23
04650075337783CloudTMS EdgeNEUROSOFT, OOOOBP2026-01-23
00850005944935NeuroStar HeadrestNEURONETICS, INC.OBP2025-12-15
00850005944935NeuroStar HeadrestNEURONETICS, INC.QCI2025-12-15
05713484020482MagProTonica Elektronik A/SOBP2025-12-11
05713484031181MagPro accessoriesTonica Elektronik A/SOBP2025-12-11
05713484031440MagPro accessoriesTonica Elektronik A/SQCI2025-12-11