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    K Number
    K241646
    Device Name
    ORTIV (ORTIV-BL, ORTIV-WH)
    Manufacturer
    MVITRO CO., LTD.
    Date Cleared
    2024-11-01

    (147 days)

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

    MVITRO CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ORTIV is a portable, battery-operated laser lancing device indicated for obtaining capillary blood samples in both institutional and at-home settings.
    Device Description
    ORTIV laser lancet is a portable, battery-operated laser lancing device, and is indicated for obtaining capillary blood samples in both institutional and at-home settings. The laser is a pulsed Erbium YAG (ER: YAG). It outputs a single pulse of laser light with a wavelength of 2940 nm, which ablates a small hole in the skin to a depth sufficient to access capillary blood.
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