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510(k) K243539

Apollo TMS Therapy System by Mag & More GmbH — Product Code OBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2025
Date Received
November 15, 2024
Clearance Type
Traditional
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 Mag & More GmbH

  • K243700 — Apollo TMS Therapy System (September 4, 2025)
  • K232639 — Apollo TMS Therapy System (May 24, 2024)
  • K180313 — Apollo TMS Therapy System (May 4, 2018)

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)
  • 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)
  • K243460 — Ultimate rTMS (April 17, 2025)