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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 K171647
Device Name BeneLife Premium Facial Treatment Pack, Model: QZ0701A
Applicant
Infinitus (China) Company Ltd.
17/F, Infinitus Centre, No.12 Zhujiang West Rd., Tianhe Dist
Guangzhou,  CN
Applicant Contact Judy Zhou
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 Code
OHS  
Date Received06/05/2017
Decision Date 10/23/2017
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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