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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 K212907
Device Name Aimanfun Lumea Comfort, A-2789/A-3588
Applicant
Kam Yuen Plastic Products Ltd.
No. 2, Heng Feng Two Road, Pu Jin Industrial, Konghou Town
ZhongShan,  CN 518100
Applicant Contact Anna Dan
Correspondent
Guangdong Jianda Medical Technology Co Ltd
906 Room, Longxiang Garden, Tianhe District
Guangzhou,  CN
Correspondent Contact Jett Lee
Regulation Number878.4810
Classification Product Code
ONF  
Date Received09/13/2021
Decision Date 12/02/2021
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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