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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 K250425
Device Name Ultraviolet Phototherapy Device
Applicant
APK Technology Co., Ltd.
6 Floor, Bldg. B2, Industry Of Hengfeng, # 739, Zhoushi
Hezhou, Hangcheng St., Bao’An District
Shenzhen,  CN 518100
Applicant Contact Caifang Wang
Correspondent
Manton Business and Technology Services
37 Winding Ridge
Oakland,  NJ  07436
Correspondent Contact Melody Huang
Regulation Number878.4630
Classification Product Code
FTC  
Date Received02/14/2025
Decision Date 04/07/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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