510(k) clearance

308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A)

FDA 510(k) source

510(k) number

K262885

Applicant

Guangxi Hope Medical Devices Technology Co., Ltd.

Decision date

Oct 14, 2026

Date received

Aug 17, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

FTC

Device type

Light, Ultraviolet, Dermatological

Device class

Class II

Regulation

21 CFR 878.4630

Advisory committee

General, Plastic Surgery

Statement or summary

Summary

Third party

N

Location

Yulin, CN