Cleared Traditional

StarFormer (M008-3T)

K241785 · Fotona D.O.O. · Physical Medicine

Mar 2025

Decision

280d

Days

Class 2

Risk

About This 510(k) Submission

K241785 is an FDA 510(k) clearance for the StarFormer (M008-3T), a Electromagnetic Stimulator, Pain Relief (Class II — Special Controls, product code QPL), submitted by Fotona D.O.O. (Ljubljana, SI). The FDA issued a Cleared decision on March 27, 2025, 280 days after receiving the submission on June 20, 2024. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K241785 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2024
Decision Date	March 27, 2025
Days to Decision	280 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

Device Classification

Product Code	QPL — Electromagnetic Stimulator, Pain Relief
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5890
Definition	Intended To Apply A Magnetic-field Induced Electrical Current To Treat Pain.