Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)— 510(k) K243764

Name: FDA 510(k) clearance K243764
Creator: U.S. Food and Drug Administration
Published: 2025-05-08

Substantially Equivalent

Wuhan Pioon Technology Co., Ltd.

FDA 510(k) clearance K243764 for Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W), Substantially Equivalent on 2025-05-08. Applicant: Wuhan Pioon Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Wuhan Pioon Technology Co., Ltd.
Product code: Code NVK
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2024-12-06
Decision date: 2025-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuhan, 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.