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FDA 510(k)

NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar

K-Number: K212289 · 2022-05-06

ApplicantNeuronetics, Inc.
Decision Date2022-05-06
Product CodeQCI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar is the device name listed in this FDA 510(k) record. The listed applicant is Neuronetics, Inc.. It received FDA 510(k) clearance on 2022-05-06 under 510(k) number K212289. The device is classified under product code QCI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar?

NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is Neuronetics, Inc.. The 510(k) number is K212289.

When did NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar receive FDA 510(k) clearance?

NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar received FDA 510(k) clearance on 2022-05-06, under 510(k) number K212289.

Who is the listed applicant for NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar?

The FDA 510(k) record lists Neuronetics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar?

The FDA product code for NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar is QCI.

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Other records listing Neuronetics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231926NeuroStar Advanced Therapy System (All previously cleared models)K233621NeuroStar Advanced Therapy System (Version 3.8)K231350OCD MT Cap (85-00397-000)K230029NeuroStar Advanced Therapy System (Version 3.7)K222230NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental HealthK220127NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health

View all 11 devices →

Related Devices (Code: QCI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260402MeRT SystemWave NeuroscienceK243459Ultimate rTMS for OCD (M-series)Brain Ultimate, Inc.K230657BTL-99-OCBTL Industries, Inc.K233742CloudTMS Edge for OCDTeleemg, LLCK231350OCD MT Cap (85-00397-000)NeuroneticsK221129CloudTMS for OCDTeleemg, LLC

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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