# K233621: NeuroStar Advanced Therapy System (Version 3.8)

- Pathway: 510(k) (Special)
- Applicant: Neuronetics
- Decided: Dec 13, 2023 after 30 days
- Product code: OBP (Transcranial Magnetic Stimulator)
- Device class: 2
- Regulation: 21 CFR 882.5805
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to DEN070003 (2008). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083538: Neurostar TMS Therapy System, Model 1.1, Neuronetics (2008) Summary page 4.
- K130233: Neurostar TMS Therapy System, Neuronetics (2013) Summary page 4.
- K133408: Neurostar TMS Therapy System, Neuronetics (2014) Summary page 4.
- K160703: NeuroStar TMS Therapy System, Neuronetics, Inc. (2016) Summary page 4.
- K161519: NeuroStar TMS Therapy System, Neuronetics, Inc. (2016) Summary page 4.
- K201158: NeuroStar Advanced Therapy, Neuronetics, Inc. (2020) Summary page 4.
- K220127: NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health, Neuronetics, Inc. (2022) Summary page 4.
- K230029: NeuroStar Advanced Therapy System (Version 3.7), Neuronetics (2023) Summary page 4.
- K212289: NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar, Neuronetics, Inc. (2022) Summary page 4.

## Most influential descendants
- K260691: BTL-699 (2026), 0 descendants of its own

## Recalls of this device
- Aug 24, 2026 · Class II · Z-0142-2027: Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.

## Indications for use
The NeuroStar Advanced Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode. The NeuroStar Advanced Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

Source page: https://510kreport.com/device/K233621
Methodology: https://510kreport.com/methodology