Menovex Medical Technology (Shenzhen) Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
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.
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.
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
SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)
K251303 references 1 predicate/reference device
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