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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 K243430
Device Name Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
Applicant
Shenzhen Aozemei Technology Co., Ltd.
3/F, Bldg. 9, Tianfu 'An Industrial Park, Lezhujiao
Huangmabu Community, Hangcheng St., Baoan District
Shenzhen,  CN 518128
Applicant Contact Zemin Wu
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center, # 3101-90, Qia
Shenzhen,  CN 518052
Correspondent Contact Riley Chen
Regulation Number882.5890
Classification Product Code
NFO  
Date Received11/05/2024
Decision Date 12/19/2024
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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