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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 K231215
Device Name IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S
Applicant
Zhongshan Qizhe Technology Co., Ltd.
23 Tongji W. Rd., Nantou Town, Rm. 902,
Bldg. 8, Hongji Industrial City Phase Ii
Zhongshan,  CN 528427
Applicant Contact Gan Guiping
Correspondent
Qimmiq Medical Consulting Service Co., Ltd.
Rm.406, Bldg. C, Run Science Park, #18 Shenzhou Rd.
Huangpu
Guangzhou,  CN 510663
Correspondent Contact You Yijie
Regulation Number878.4810
Classification Product Code
OHT  
Date Received04/28/2023
Decision Date 06/26/2023
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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