FDA.reportPublic FDA data

tamburo Thulium Fiber Laser System

Primary DI
06974994310398
Brand
tamburo Thulium Fiber Laser System
Company
menovex Medical Technology (Shenzhen) Co., Ltd
Model
MIL-TFL-600B
Device description
The Tamburo Thulium Fiber Laser System is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy gastroenterological surgery and gynecological surgery.
Published
2025-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251303000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251303000Tamburo Thulium Fiber Laser SystemMenovex Medical Technology (Shenzhen) Co., Ltd.2025-11-04GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974994310398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974994310398069749943103986974994310398

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for general surgery and/or multiple specialized surgical applications (non-dedicated), which may include treatment of vascular diseases. It vaporizes/ablates soft tissue with moderate haemostasis, little charring, and a thin zone of necrosis. It includes a light source, delivery/positioning device(s), and controls/foot-switch and emits a midinfrared wavelength. It does not include frequency doubling technology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
709445289
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974994310350tamburo Thulium Fiber Laser SystemMIL-TFL-600A2025-12-11
06974994310404tamburo Thulium Fiber Laser SystemMIL-TFL-600C2025-12-11
06974994310411tamburo Thulium Laser FiberSF-150-APA2025-12-11
06974994310428tamburo Thulium Laser FiberSF-150-BPA2025-12-11
06974994310435tamburo Thulium Laser FiberSF-200-APA2025-12-11
06974994310442tamburo Thulium Laser FiberSF-200-BPA2025-12-11
06974994310459tamburo Thulium Laser FiberSF-272-APA2025-12-11
06974994310466tamburo Thulium Laser FiberSF-272-BPA2025-12-11
06974994310473tamburo Thulium Laser FiberSF-365-APA2025-12-11
06974994310480tamburo Thulium Laser FiberSF-365-BPA2025-12-11
06974994310497tamburo Thulium Laser FiberSF-550-APA2025-12-11
06974994310503tamburo Thulium Laser FiberSF-550-BPA2025-12-11
06974994310510tamburo Thulium Laser FiberSF-800-APA2025-12-11
06974994310527tamburo Thulium Laser FiberSF-800-BPA2025-12-11

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