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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K231894
Device Name LED Spectrum therapy instrument
Applicant
Shenzhenshi Sincoheren S&T Development Co.,Ltd.
Floor 4,No.2 Plant,No.14 Zhongxing Road,Xiuxin Community,
Kengzi Street Office,Pingshan District
Shenzhen,  CN 518118
Applicant Contact Zhongzhou Li
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd.,
FangShan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
ILY  
Date Received06/28/2023
Decision Date 09/20/2023
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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