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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K252146
Device Name Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)
Applicant
Shenzhen Siken 3D Technology Development Co., Ltd.
Rm.1104, Bldg. 2, Xinweirun High-Tech Park, # 162, Shajiang
Rd Xitou Community, Shajiang Rd. Songgang St., Bao'An Distri
Shenzhen,  CN 518105
Applicant Contact Jing Quan Liu
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center,
# 3101-90 Qianhai Rd.
Shenzhen,  CN 518052
Correspondent Contact Bing Huang
Regulation Number882.5890
Classification Product Code
NFO  
Date Received07/09/2025
Decision Date 12/23/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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