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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 K260974
Device Name CO2 Laser Machine (Monica-I,Monica-II)
Applicant
Nanjing Bestview Laser S&T Co., Ltd.
1st & 2nd Floor, Bldg. 5, Area 1, Phase 2, Liandong U Valley
Nanjing,  CN 210000
Applicant Contact Jing Wang
Correspondent
Nanjing Bestview Laser S&T Co., Ltd.
1st & 2nd Floor, Bldg. 5, Area 1, Phase 2, Liandong U Valley
Nanjing,  CN 210000
Correspondent Contact Jing Wang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/24/2026
Decision Date 05/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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