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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 K251303
Device Name Tamburo Thulium Fiber Laser System
Applicant
Menovex Medical Technology (Shenzhen) Co., Ltd.
401, 501, Bldg. 13, Biomedicine Innovation Industrial
Park, # 14, Jinhui Rd.
Shenzhen,  CN 518118
Applicant Contact Xueying Qin
Correspondent
Landlink Healthcare Technology (Shanghai) Co., Ltd.
Rm.1308, Baohua International Plz., W. Guangzhong Rd.
Jingan District
Shanghai,  CN
Correspondent Contact Kyra Kang
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/28/2025
Decision Date 11/04/2025
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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