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FDA 510(k)

NeuroStar Advanced Therapy System (Version 3.8)

K-Number: K233621 · 2023-12-13

ApplicantNeuronetics
Decision Date2023-12-13
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NeuroStar Advanced Therapy System (Version 3.8) is a medical device manufactured by Neuronetics. It received FDA 510(k) clearance on 2023-12-13 under approval number K233621. 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 System (Version 3.8)?

NeuroStar Advanced Therapy System (Version 3.8) is a medical device that received FDA 510(k) clearance on 2023-12-13. It is manufactured by Neuronetics. The 510(k) number is K233621.

When was NeuroStar Advanced Therapy System (Version 3.8) approved by the FDA?

NeuroStar Advanced Therapy System (Version 3.8) received FDA 510(k) clearance on 2023-12-13, under approval number K233621.

What company makes NeuroStar Advanced Therapy System (Version 3.8)?

NeuroStar Advanced Therapy System (Version 3.8) is manufactured by Neuronetics.

What is the FDA product code for NeuroStar Advanced Therapy System (Version 3.8)?

The FDA product code for NeuroStar Advanced Therapy System (Version 3.8) is OBP.

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING

Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025) PMID: 40406702 Toward a unified gait freeze index: a standardized benchmark for clinical and regulatory evaluations. Frontiers in neurology (2025)

Other Devices by Neuronetics

K231350OCD MT Cap (85-00397-000) K230029NeuroStar Advanced Therapy System (Version 3.7)

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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