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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 K162652
Device Name Smart Photon Micro-current Device, Model: EP-300
Applicant
LI-TEK ELECTRONIC TECHNOLOGY CORPORATION
NO.8-13, THE INDUSTRIAL PARK OF JINSHAGANG,
SHIXIAVILLAGE, DALANGTOWN
DONGGUAN,  CN
Applicant Contact Barry Yuan
Correspondent
Guangzhou LETA Testing Technology Co., Ltd
6F, No.1 TianTai Road, Science City, LuoGang District
Guangzhou,  CN
Correspondent Contact Jet Li
Regulation Number882.5890
Classification Product Code
NFO  
Subsequent Product Codes
OHS   OLP  
Date Received09/23/2016
Decision Date 10/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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