NeuroStar Advanced Therapy System (Version 3.8)
FDA 510(k)Class II (US FDA 510(k))
by Neuronetics
Identifiers
- 510(k) Number
- K233621 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 System is a transcranial magnetic stimulator classified as a Class II medical device. It is a computerized, electromechanical device that delivers non-invasive magnetic fields to induce electrical currents in the cerebral cortex.
It is supplied as a reusable system for use in clinical settings such as neurology practices. The device received FDA 510(k) clearance (K233621) on December 13, 2023, and is manufactured by Neuronetics in Malvern, PA.
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: PDF December 13, 2023 Neuronetics Amanda Pentecost Sr. Regulatory Affairs ..., NeuroStar Advanced Therapy System (Version 3.8) (K233621) — FDA 510(k ..., NeuroStar Advanced Therapy System (Version 3.8) — FDA K233621
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233621 | Class II | Active |
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Manufacturer
- Manufacturer
- Neuronetics
Sources (1)
- FDA 510(k) K233621 24 fields · synced Sep 25, 2026