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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 K162106
Device Name Micro-current Wrinkle Reduction Facial service, model EP-400
Applicant
Li-Tek Electronic Technology Corporation
#8~13,The Industrial Park Of Jinshagang
Shixiavillage, Dalangtown
Dongguan,  CN
Applicant Contact Barry Yuan
Correspondent
Guangzhou Leta Testing Technology Co., Ltd.
6f, #1 Tiantai Rd., Science City, Luogang District
Gaungzhou,  CN
Correspondent Contact Jet Li
Regulation Number882.5890
Classification Product Code
NFO  
Subsequent Product Code
OHS  
Date Received07/29/2016
Decision Date 02/03/2017
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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