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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 K211174
Device Name IPL Hair Removal
Applicant
Shenzhen Qiaochengli Technology Co., Ltd.
501-5, Rujun Bldg., 105 Zhongxing Rd.,
Ma’Antang Community, Bantian St., Longgang District
Shenzhen,  CN
Applicant Contact LiPing Zhou
Correspondent
Guangzhou Keda Biological Tech Co., Ltd.
6f, #1 Tiantai Rd., Science City, Luogang District
Gaungzhou,  CN
Correspondent Contact Jet Li
Regulation Number878.4810
Classification Product Code
OHT  
Date Received04/20/2021
Decision Date 09/01/2021
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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