WinForth (LM-E470KA)— 510(k) K250916

Name: FDA 510(k) clearance K250916
Creator: U.S. Food and Drug Administration
Published: 2025-08-14

Substantially Equivalent

Shenzhen Leaflife Technology Co., Ltd.

FDA 510(k) clearance K250916 for WinForth (LM-E470KA), Substantially Equivalent on 2025-08-14. Applicant: Shenzhen Leaflife Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Leaflife Technology Co., Ltd.
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2025-03-27
Decision date: 2025-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.