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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 K190820
Device Name Aimanfun Lumea Comfort
Applicant
Kam Yuen Plastic Products Ltd
No. 2, Heng Feng Two Road, Pu Jin Industrial, Konghou Town
Zhongshan,  CN
Applicant Contact Anna Dan
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
OHT  
Date Received04/01/2019
Decision Date 10/02/2019
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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