High Intensity Focused Electromagnetic Stimulation Device (FE60)— 510(k) K253790

Name: FDA 510(k) clearance K253790
Creator: U.S. Food and Drug Administration
Published: 2026-08-13

Substantially Equivalent

Beijing Winkonlaser Technology Limited

FDA 510(k) clearance K253790 for High Intensity Focused Electromagnetic Stimulation Device (FE60), Substantially Equivalent on 2026-08-13. Applicant: Beijing Winkonlaser Technology Limited. Device class: 2.

Clearance details

Applicant: Beijing Winkonlaser Technology Limited
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2025-11-28
Decision date: 2026-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

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