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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, # 17, Xinfa 2nd Rd., Xinqiao
Community, Xinqiao St., Baoan District
Shenzhen,  CN 518125
Applicant Contact Endang Cheng
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  
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
Predetermined Change
Control Plan Authorized		 No
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