Apollo TMS Therapy System;Apollo light TMS Therapy System

FDA 510(k) K260560 · Mag & More GmbH

Substantially Equivalent

510(k) numberK260560

Submission

Device name
Apollo TMS Therapy System;Apollo light TMS Therapy System
Applicant
Mag & More GmbH
Munich, DE
Received
February 19, 2026
Decision date
May 22, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OBP – Transcranial Magnetic Stimulator
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5805
Specialty
Neurology

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 510(k)s with product code OBP

510(k)DeviceApplicantDecision
K260396KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)OBP · Traditional Fidelity BioPharma Co.09/06/2026SE
K260691BTL-699OBP · Traditional BTL Industries, Inc.08/23/2026SE
K261228QuickVision Ultimate rTMSOBP · Traditional Brain Ultimate, Inc.08/14/2026SE
K260189MagVenture Accelerated TMS (aTMS) Therapy SystemOBP · Traditional Tonica Elektronik A/S05/22/2026SE
K253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)OBP · Traditional Nexstim Oyj03/20/2026SE
K252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)OBP · Traditional Nexstim Oyj03/20/2026SE
K251653SPRY TMS Therapy System (0550)OBP · Traditional Soterix Medical, Inc.02/20/2026SE
K251391BrainsWay Deep TMS SystemOBP · Traditional Brainsway , Ltd.11/07/2025SE
K250689CloudTMS EdgeOBP · Traditional Teleemg, LLC09/14/2025SE
K251449BrainsWay Deep TMS SystemOBP · Traditional Brainsway , Ltd.09/13/2025SE

More from Brainsway , Ltd.

510(k)DeviceDecision
K243700Apollo TMS Therapy SystemOBP · Traditional 09/04/2025SE
K243539Apollo TMS Therapy SystemOBP · Traditional 08/18/2025SE
K232639Apollo TMS Therapy SystemOBP · Traditional 05/24/2024SE
K180313Apollo TMS Therapy SystemOBP · Abbreviated 05/04/2018SE

Questions and answers

When was Apollo TMS Therapy System;Apollo light TMS Therapy System cleared by the FDA?

Apollo TMS Therapy System;Apollo light TMS Therapy System (K260560) received a 510(k) decision of Substantially Equivalent on May 22, 2026, 92 days after the submission was received.

What is the product code of K260560?

The FDA product code is OBP – Transcranial Magnetic Stimulator, a Class II (moderate risk) device regulated under 21 CFR 882.5805.