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FDA 510(k)

NeuroStar Advanced Therapy

K-Number: K201158 · 2020-11-20

ApplicantNeuronetics, Inc.
Decision Date2020-11-20
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NeuroStar Advanced Therapy is a medical device manufactured by Neuronetics, Inc.. It received FDA 510(k) clearance on 2020-11-20 under approval number K201158. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeuroStar Advanced Therapy?

NeuroStar Advanced Therapy is a medical device that received FDA 510(k) clearance on 2020-11-20. It is manufactured by Neuronetics, Inc.. The 510(k) number is K201158.

When was NeuroStar Advanced Therapy approved by the FDA?

NeuroStar Advanced Therapy received FDA 510(k) clearance on 2020-11-20, under approval number K201158.

What company makes NeuroStar Advanced Therapy?

NeuroStar Advanced Therapy is manufactured by Neuronetics, Inc..

What is the FDA product code for NeuroStar Advanced Therapy?

The FDA product code for NeuroStar Advanced Therapy is OBP.

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Related PubMed Literature

PMID: 40406702 Toward a unified gait freeze index: a standardized benchmark for clinical and regulatory evaluations. Frontiers in neurology (2025) PMID: 40069892 Enhanced mitochondrial function and delivery from adipose-derived stem cell spheres via the EZH2-H3K27me3-PPARγ pathway for advanced therapy. Stem cell research & therapy (2025)

Other Devices by Neuronetics, Inc.

K161519NeuroStar TMS Therapy System K160703NeuroStar TMS Therapy System K213543NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health K222230NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health K220127NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health K212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar

View all 8 devices →

Related Devices (Code: OBP)

K160309Neurosoft TMSTeleemg, LLC K161519NeuroStar TMS Therapy SystemNeuronetics, Inc. K160703NeuroStar TMS Therapy SystemNeuronetics, Inc. K173441Neurosoft TMS (also CloudTMS)Teleemg, LLC K171902Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc K172667MagVita TMS Therapy w/MagPro R20Tonica Elektronik A/S

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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