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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 K220927
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 Guoming Zhou
Correspondent
Shenzhen Qiaochengli Technology Co., Ltd.
501-5, Rujun Bldg., 105 Zhongxing Rd.,
Ma’Antang Community, Bantian St., Longgang District
Shenzhen,  CN
Correspondent Contact Guoming Zhou
Regulation Number878.4810
Classification Product Code
OHT  
Date Received03/31/2022
Decision Date 06/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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