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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, S. Of Xinhua Rd.
Bao’An District
Shenzhen,  CN
Applicant Contact Aaron Zhai
Correspondent
Guangzhou Keda Testing Tech Co., Ltd.
6f, #1 Tiantai Rd., Science City, Luogang District
Gaungzhou,  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
Predetermined Change
Control Plan Authorized		 No
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