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510(k) K251303

Device
Tamburo Thulium Fiber Laser System
Applicant
Menovex Medical Technology (Shenzhen) Co., Ltd.
510(k) number
K251303
Product code
GEX
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-04
Date received
2025-04-28
Regulation
878.4810
Classification name
Powered Laser Surgical Instrument
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Xueying Qin
Address
401, 501, Bldg. 13, Biomedicine Innovation Industrial Park, # 14, Jinhui Rd. Shenzhen CN 518118 518118

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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