NeuroStar Advanced Therapy
FDA 510(k) K201158 · Neuronetics, Inc.
510(k) numberK201158
Submission
- Device name
- NeuroStar Advanced Therapy
- Applicant
- Neuronetics, Inc.
Malvern, PA, US - Received
- April 30, 2020
- Decision date
- November 20, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBP – Transcranial Magnetic Stimulator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5805
- Specialty
- Neurology
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.
Other 510(k)s with product code OBP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260396 | KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)OBP · Traditional | Fidelity BioPharma Co. | 09/06/2026SE |
| K260691 | BTL-699OBP · Traditional | BTL Industries, Inc. | 08/23/2026SE |
| K261228 | QuickVision Ultimate rTMSOBP · Traditional | Brain Ultimate, Inc. | 08/14/2026SE |
| K260560 | Apollo TMS Therapy System;Apollo light TMS Therapy SystemOBP · Traditional | Mag & More GmbH | 05/22/2026SE |
| K260189 | MagVenture Accelerated TMS (aTMS) Therapy SystemOBP · Traditional | Tonica Elektronik A/S | 05/22/2026SE |
| K253098 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)OBP · Traditional | Nexstim Oyj | 03/20/2026SE |
| K252358 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)OBP · Traditional | Nexstim Oyj | 03/20/2026SE |
| K251653 | SPRY TMS Therapy System (0550)OBP · Traditional | Soterix Medical, Inc. | 02/20/2026SE |
| K251391 | BrainsWay Deep TMS SystemOBP · Traditional | Brainsway , Ltd. | 11/07/2025SE |
| K250689 | CloudTMS EdgeOBP · Traditional | Teleemg, LLC | 09/14/2025SE |
More from Teleemg, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K231926 | NeuroStar Advanced Therapy System (All previously cleared models)OBP · Traditional | 03/22/2024SE |
| K233621 | NeuroStar Advanced Therapy System (Version 3.8)OBP · Special | 12/13/2023SE |
| K231350 | OCD MT Cap (85-00397-000)QCI · Special | 06/08/2023SE |
| K230029 | NeuroStar Advanced Therapy System (Version 3.7)OBP · Traditional | 04/04/2023SE |
| K222230 | NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar…OBP · Special | 08/24/2022SE |
| K220127 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar…OBP · Traditional | 07/15/2022SE |
| K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy…QCI · Traditional | 05/06/2022SE |
| K213543 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar…OBP · Special | 12/10/2021SE |
| K161519 | NeuroStar TMS Therapy SystemOBP · Traditional | 09/11/2016SE |
| K160703 | NeuroStar TMS Therapy SystemOBP · Traditional | 06/10/2016SE |
Questions and answers
When was NeuroStar Advanced Therapy cleared by the FDA?
NeuroStar Advanced Therapy (K201158) received a 510(k) decision of Substantially Equivalent on November 20, 2020, 204 days after the submission was received.
What is the product code of K201158?
The FDA product code is OBP – Transcranial Magnetic Stimulator, a Class II (moderate risk) device regulated under 21 CFR 882.5805.