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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 K251329
Device Name Diode laser device (RF3120-BI)
Applicant
Risu Medical Technology Co., Ltd.
Rm.201, Bldg. 11, Western Cloud Valley(Phase Iii)
Intercection Of Kangding Rd. And Tongwen Rd.
Fengxi New City Of Xixian New Area,  CN 712000
Applicant Contact Tianqiang Yu
Correspondent
Risu Medical Technology Co., Ltd.
Rm.201, Bldg. 11, Western Cloud Valley(Phase Iii)
Intercection Of Kangding Rd. And Tongwen Rd.
Fengxi New City Of Xixian New Area,  CN 712000
Correspondent Contact Tianqiang Yu
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/30/2025
Decision Date 06/27/2025
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
Predetermined Change
Control Plan Authorized		 No
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