308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A)— 510(k) K262885

Name: FDA 510(k) clearance K262885
Creator: U.S. Food and Drug Administration
Published: 2026-10-14

Substantially Equivalent

Guangxi Hope Medical Devices Technology Co., Ltd.

FDA 510(k) clearance K262885 for 308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A), Substantially Equivalent on 2026-10-14. Applicant: Guangxi Hope Medical Devices Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Guangxi Hope Medical Devices Technology Co., Ltd.
Product code: Product code FTC
Device class: Class 2
Regulation: 21 CFR 878.4630
Advisory panel: General, Plastic Surgery
Date received: 2026-08-17
Decision date: 2026-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yulin, 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.