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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered light based non-laser surgical instrument with thermal effect
510(k) Number K211368
Device Name IPL Hair Remover, Model: G993, G996, G998 and G885
Applicant
Shenzhen Mywin Technology Co., Ltd.
2nd Floor, Building B, New Age gongrong Industrial Zone,
No. 2, Shihuan Road, Shilong communit
Shenzhen,  CN
Applicant Contact Meiyun Liu
Correspondent
Guangzhou KEDA Biological Tech Co., Ltd.
6F, No.1 TianTai road, Science City, LuoGang District
GuangZhou,  CN
Correspondent Contact Jet Li
Regulation Number878.4810
Classification Product Code
ONF  
Date Received05/04/2021
Decision Date 10/04/2021
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
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