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510(k) K212289

NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar by Neuronetics, Inc. — Product Code QCI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2022
Date Received
July 21, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
Device Class
Class II
Regulation Number
882.5802
Review Panel
NE
Submission Type

External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum).

Other clearances by Neuronetics, Inc.

  • K231926 — NeuroStar Advanced Therapy System (All previously cleared models) (March 22, 2024)
  • K233621 — NeuroStar Advanced Therapy System (Version 3.8) (December 13, 2023)
  • K231350 — OCD MT Cap (85-00397-000) (June 8, 2023)
  • K230029 — NeuroStar Advanced Therapy System (Version 3.7) (April 4, 2023)
  • K222230 — NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, Neur (August 24, 2022)
  • K220127 — NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, Neur (July 15, 2022)
  • K213543 — NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, Neur (December 10, 2021)
  • K201158 — NeuroStar Advanced Therapy (November 20, 2020)
  • K161519 — NeuroStar TMS Therapy System (September 11, 2016)
  • K160703 — NeuroStar TMS Therapy System (June 10, 2016)

Other clearances for product code QCI

  • K243459 — Ultimate rTMS for OCD (M-series) (April 17, 2025)
  • K230657 — BTL-99-OC (February 1, 2024)
  • K233742 — CloudTMS Edge for OCD (December 22, 2023)
  • K231350 — OCD MT Cap (85-00397-000) (June 8, 2023)
  • K221129 — CloudTMS for OCD (March 10, 2023)
  • K193006 — MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system (August 9, 2020)
  • K183303 — Brainsway Deep TMS System (March 8, 2019)
  • DEN170078 — Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System (August 17, 2018)