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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Over The Counter Wrinkle Reduction
510(k) Number K252642
Device Name Microcurrent Facial Device (CEC101, EEI101)
Applicant
Shenzhen Dachi Communication Co., Ltd.
Rm. 201, 202, 203, Bldg. 3, Phase I, Huangtian Yangbei
Industrial Zone, Huangtian Community, Hangcheng St., Bao'
Shenzhen,  CN 518101
Applicant Contact Chunhua Xiao
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90, Qia
Shenzhen,  CN 518052
Correspondent Contact Bing Huang
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
OLP  
Date Received08/21/2025
Decision Date 11/19/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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