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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 K212881
Device Name Intense Pulsed Light (IPL) System
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 Cheng Endang
Correspondent
Qimmiq Medical Consulting Service Co., Ltd
RM. 1711 Building K, NO 101 Science Ave.
International Creative Valley Development Zone
Guangzhou,  CN
Correspondent Contact Jet You
Regulation Number878.4810
Classification Product Code
OHT  
Subsequent Product Code
ONF  
Date Received09/10/2021
Decision Date 04/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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