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The Tracker / October 2026 / K262885

510(k) cleared

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

Guangxi Hope Medical Devices Technology Co., Ltd. · Oct 14, 2026 · K262885

FDA cleared the 308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A) from Guangxi Hope Medical Devices Technology Co., Ltd. on Oct 14, 2026 under K262885, a traditional 510(k). The device falls under product code FTC, Light, Ultraviolet, Dermatological, regulated at 21 CFR 878.4630 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Aug 17, 2026. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Guangxi Hope Medical Devices Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262885?

K262885 is the FDA 510(k) for 308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A), submitted by Guangxi Hope Medical Devices Technology Co., Ltd.. FDA's decision date was Oct 14, 2026, under product code FTC (Light, Ultraviolet, Dermatological).

Who makes the 308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A)?

Guangxi Hope Medical Devices Technology Co., Ltd., based in Yulin, is the applicant of record for K262885.

How long did the K262885 review take?

FDA received the submission on Aug 17, 2026 and issued its decision on Oct 14, 2026, 58 days later.

← All decisions in October 2026