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510(k) Data Aggregation

    K Number
    K251303
    Date Cleared
    2025-11-04

    (190 days)

    Product Code
    Regulation Number
    878.4810
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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 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 Fiber:
    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.

    AI/ML Overview

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