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510(k) K213543

NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health by Neuronetics, Inc. — Product Code OBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2021
Date Received
November 8, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transcranial Magnetic Stimulator
Device Class
Class II
Regulation Number
882.5805
Review Panel
NE
Submission Type

A transcranial magnetic stimulator is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex for the treatment of major depressive disorder.

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)
  • K212289 — NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced T (May 6, 2022)
  • 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 OBP

  • K251653 — SPRY TMS Therapy System (0550) (February 20, 2026)
  • K251391 — BrainsWay Deep TMS System (November 7, 2025)
  • K250689 — CloudTMS Edge (September 14, 2025)
  • K251449 — BrainsWay Deep TMS System (September 13, 2025)
  • K243700 — Apollo TMS Therapy System (September 4, 2025)
  • K243539 — Apollo TMS Therapy System (August 18, 2025)
  • K251125 — MagVenture TMS Therapy System (August 11, 2025)
  • K251119 — MagVenture TMS Therapy System (August 8, 2025)
  • K252032 — T65 (9016E061-) (July 30, 2025)
  • K251210 — Ampa One System (AMPA-001) (June 27, 2025)