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510(k) DEN070003

NEUROSTAR TMS SYSTEM by Neuronetics — Product Code OBP

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
October 7, 2008
Date Received
May 24, 2007
Clearance Type
Post-NSE
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.

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  • 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)
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Other clearances for product code OBP

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  • 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)