NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar
FDA 510(k) K212289 · Neuronetics, Inc.
Submission
- Device name
- NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar
- Applicant
- Neuronetics, Inc.
Malvern, PA, US - Received
- July 21, 2021
- Decision date
- May 6, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QCI – Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5802
- Specialty
- Neurology
External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum).
Other 510(k)s with product code QCI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243459 | Ultimate rTMS for OCD (M-series)QCI · Traditional | Brain Ultimate, Inc. | 04/17/2025SE |
| K230657 | BTL-99-OCQCI · Traditional | BTL Industries, Inc. | 02/01/2024SE |
| K233742 | CloudTMS Edge for OCDQCI · Special | Teleemg, LLC | 12/22/2023SE |
| K231350 | OCD MT Cap (85-00397-000)QCI · Special | Neuronetics | 06/08/2023SE |
| K221129 | CloudTMS for OCDQCI · Traditional | Teleemg, LLC | 03/10/2023SE |
| K193006 | MagVenture TMS Therapy for treatment of OCD, MagVenture TMS Therapy systemQCI · Traditional | Tonica Elektronik A/S | 08/09/2020SE |
| K183303 | Brainsway Deep TMS SystemQCI · Traditional | Brainsway , Ltd. | 03/08/2019SE |
More from Brainsway , Ltd.
| 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 |
| K213543 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar…OBP · Special | 12/10/2021SE |
| K201158 | NeuroStar Advanced TherapyOBP · Traditional | 11/20/2020SE |
| 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 for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar cleared by the FDA?
NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar (K212289) received a 510(k) decision of Substantially Equivalent on May 6, 2022, 289 days after the submission was received.
What is the product code of K212289?
The FDA product code is QCI – Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder, a Class II (moderate risk) device regulated under 21 CFR 882.5802.