NeuroStar Advanced Therapy Transcranial Magnetic Stimulator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K201158 FDA 510(k)
- FDA Product Code
- OBP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5805 FDA 510(k)
- Regulation Number
- 882.5805 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The NeuroStar Advanced Therapy is a transcranial magnetic stimulator, a non-invasive device designed to modulate neural activity in the brain through the application of magnetic fields. It is classified as a Class II medical device and is intended for use in neurological treatments, specifically for conditions such as depression where traditional therapies have been ineffective. The device delivers focused magnetic pulses to targeted brain regions, aiming to restore balanced neural function without surgical intervention or systemic drug administration.
This device is supplied as a reusable medical system, requiring calibration and maintenance by trained personnel. It operates in clinical settings, including outpatient mental health facilities and hospitals, and is regulated under FDA 510(k) clearance (K201158) as substantially equivalent to prior-generation devices. The NeuroStar Advanced Therapy is not MRI-compatible and must be stored in a controlled environment to preserve its functionality and safety. No single-use or sterility claims are specified in the regulatory data.
Frequently asked questions
What is the NeuroStar Advanced Therapy used for?
The NeuroStar Advanced Therapy is a transcranial magnetic stimulator designed to modulate neural activity in the brain. It is specifically intended for neurological treatments, particularly for depression when traditional therapies have not been effective. The device delivers focused magnetic pulses to targeted brain regions to help restore balanced neural function without surgery or systemic drug administration.
How is the NeuroStar Advanced Therapy supplied and maintained?
The NeuroStar Advanced Therapy is supplied as a reusable medical system. It requires calibration and maintenance by trained personnel to ensure proper functionality and safety. This makes it suitable for use in clinical settings like outpatient mental health facilities and hospitals, where staff can manage its upkeep.
Is the NeuroStar Advanced Therapy single-use or reusable?
The NeuroStar Advanced Therapy is a reusable device. It is not designed for single-use, and its maintenance and calibration are essential to its continued safe and effective operation in clinical environments.
What storage conditions are required for the NeuroStar Advanced Therapy?
The NeuroStar Advanced Therapy must be stored in a controlled environment to preserve its functionality and safety. This ensures that the device remains operational and reliable for clinical use, as specified in the manufacturer’s guidelines.
Can the NeuroStar Advanced Therapy be used in an MRI environment?
No, the NeuroStar Advanced Therapy is not MRI-compatible. It must be used in settings where MRI procedures are not conducted simultaneously, as the magnetic fields from MRI machines could interfere with its operation or pose safety risks.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Neuronetics - NeuroStar TMS, NeuroStar - TMS Treatment For Depression | Advanced Therapy, Neuronetics Announces NeuroStar® Advanced Therapy for Mental Health ..., NeuroStar® Advanced Therapy Receives FDA Clearance ... - Neuronetics Inc
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201158 | Class II | Active |
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Manufacturer
- Manufacturer
- Neuronetics, Inc.
Sources (1)
- FDA 510(k) K201158 24 fields · synced Oct 1, 2026