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510(k) Data Aggregation

    K Number
    K250504
    Device Name
    Leonardo Duster
    Manufacturer
    CeramOptec GmbH
    Date Cleared
    2025-07-14

    (144 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    CeramOptec GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K210951
    Device Name
    Leonardo Mini Blue
    Manufacturer
    CeramOptec GmbH
    Date Cleared
    2021-09-01

    (155 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    CeramOptec GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Leonardo Mini Blue 445nm Laser is intended for incision, vaporization, ablation, hemostasis and coagulation of soft tissue.
    Device Description
    The laser family LEONARDO® Mini Blue is a laser system with functions and ergonomics specially developed for medical applications. A control panel is used to set treatment parameters, such as laser power. User-friendly menu navigation ensures a reliable operation while allowing physicians to concentrate on the essential aspects of treatment. The fiber-coupled semiconductor laser diodes convert electrical energy to coherent laser radiation with the wavelength of 445 nm (aiming beam 635 nm). A beam transporting system delivers this energy to affected surfaces and organs. Depending on the model, the LEONARDO® Mini Blue laser has the following maximum laser output power: LEONARDO® Mini Blue: 10W@445nm. LEONARDO® Mini Blue is available as a single-wavelength device with 445 nm. All LEONARDO® Mini Blue laser can be operated in continuous mode. Additional special treatment modes for specific treatment procedures or in combination with corresponding application fibers are available, depending on the configuration of the unit. For safety reasons, the LEONARDO® Mini Blue laser is equipped with a system for automatic recognition of the optical fibers used. Application fibers from CeramOptec have coding for communicating with the laser device.
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