Manufacturer
Menovex Medical Technology (Shenzhen) Co., Ltd.Tamburo Thulium Fiber Laser System
Menovex Medical Technology (Shenzhen) Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K251303
- Device name
- Tamburo Thulium Fiber Laser System
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-04-28
- Decision date
- 2025-11-04
- Submission type
- Traditional
- Technology type
- Thulium fiber(AI inferred)
- Clinical applications
- Surgical cuttingOtherOtherOther
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The Tamburo Thulium Fiber Laser System are 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.
Intended Use
The Tamburo Thulium Fiber Laser System are 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.
Device Description
The Tamburo is a Thulium fiber laser device emitting at a wavelength of 1940 nm, which is used by physicians as a tool in surgical procedures. This device consists of a thulium laser, footswitch, power cord, Interlock connector, ground wire and protective goggles. The thulium laser includes thulium laser, cooling device, aiming beam device, and LCD touch screen. Tamburo Thulium Laser Fibers are delivery devices that transmit laser energy from the laser console to the treatment site through the fiber tip. The laser connector secures the device to the laser. This device consists of a fiber, dust cap, ferrule, outer cap and handle. The fiber includes core, cladding, coating and outer jacket. Tamburo Thulium Laser Fibers are compatible for use with Tamburo Thulium Laser Systems.
Summary parsed at:2026-06-01 05:23:05 UTC
Predicate devices
1SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)
K251303 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K251303 as a predicate
