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510(k) Data Aggregation

    K Number
    K220793
    Device Name
    InnoVoyce Laser Fiber
    Manufacturer
    Date Cleared
    2022-05-25

    (68 days)

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

    InnoVoyce LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    InnoVoyce Laser Fiber is intended for use in incision, vaporization, ablation, and coagulation of soft tissue.
    Device Description
    The InnoVoyce Laser Fibers are sterile, single use, disposable laser delivery devices designed to deliver laser energy at 532 nm (KTP) for use in incision/excision, vaporization, ablation, and coagulation of soft tissue. The laser fibers are used as an accessory to the Aura KTP medical laser. They are 12 feet (3.66m) long glass fibers in flexible jackets, and they are available in three sizes 300, 400, and 600 Microns. The choice of the fiber diameter is dependent upon the surgical procedure, the desired tissue effects, and the personal preference of the surgeon. Fibers with small core diameters minimize lateral tissue damage, are more flexible, and tend to cut faster when used in contact than larger diameter fibers. The InnoVoyce Laser Fibers have a proprietary connector meeting the Aura XP surgical laser console interface requirements which includes: custom bayonet-style engagement to the system, and fiber model recognition. The InnoVoyce Laser Fibers transmit maximum power available from the Aura XP at 15w. This fiber within the surgical laser system will be operated by a surgeon and a laser safety officer.
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