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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 hair removal
510(k) Number K183217
Device Name IPL Hair Removal Device
Applicant
Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.
7/F, Marina Bay Centre A, South of Xinhua Road
Bao’an District
Shenzhen,  CN
Applicant Contact Aaron Zhai
Correspondent
Guangzhou KEDA Testing Tech Co., Ltd.
6F, No.1 TianTai road, Science City, LuoGang District
GuangZhou,  CN
Correspondent Contact Jet Li
Regulation Number878.4810
Classification Product Code
OHT  
Subsequent Product Code
ONF  
Date Received11/19/2018
Decision Date 02/15/2019
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
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