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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Ultraviolet, Dermatological
510(k) Number K262885
Device Name 308nm Ultraviolet Light Therapy Device (XWYL-401A, XWYL-403A)
Applicant
Guangxi Hope Medical Devices Technology Co., Ltd.
1st And 2nd Floor, Bldg. 3,Yulin Traditional Chinese Medicin
Yulin,  CN 537000
Applicant Contact Bing Wang
Correspondent
Flying Drug & Medical Compliance Service Co., Ltd.
Rm. 1505 Zhenye International Business Center, Qianhai Rd.
Shenzhen,  CN 518055
Correspondent Contact Qin Wang
Regulation Number878.4630
Classification Product Code
FTC  
Date Received08/17/2026
Decision Date 10/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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