Cleared Traditional

Apollo TMS Therapy System

K243700 · Mag & More GmbH · Neurology
Sep 2025
Decision
279d
Days
Class 2
Risk

About This 510(k) Submission

K243700 is an FDA 510(k) clearance for the Apollo TMS Therapy System, a Transcranial Magnetic Stimulator (Class II — Special Controls, product code OBP), submitted by Mag & More GmbH (Munich, DE). The FDA issued a Cleared decision on September 4, 2025, 279 days after receiving the submission on November 29, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5805.

Submission Details

510(k) Number K243700 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 2024
Decision Date September 04, 2025
Days to Decision 279 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code OBP — Transcranial Magnetic Stimulator
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5805
Definition 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.