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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 K221569
Device Name Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K
Applicant
Shenzhen Fansizhe Science And Technology Co., Ltd
2nd and 3rd floors, No. 17, Xinfa 2nd Road, Xinqiao
Community, Xinqiao Street, Baoan District
Shenzhen,  CN 518125
Applicant Contact Endang Cheng
Correspondent
Qimmiq Medical Consulting Service Co., Ltd.
RM.406, Building C, Run Science Park,
No.18 Shenzhou Road, Huangpu
Guangzhou,  CN 510663
Correspondent Contact You Yijie
Regulation Number878.4810
Classification Product Code
OHT  
Subsequent Product Code
ONF  
Date Received05/31/2022
Decision Date 06/30/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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