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510(k) Data Aggregation

    K Number
    K172818
    Device Name
    LMT-3000
    Manufacturer
    Lameditech Co., Ltd.
    Date Cleared
    2018-03-07

    (170 days)

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

    Lameditech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LMT-3000 is a portable, battery-operated laser lancing device indicated for obtaining capillary blood samples in both institutional and at-home settings.
    Device Description
    The LMT-3000 lancing device uses a battery-powered laser beam (Er:YAG laser technology), which makes a tiny hole in the skin to obtain a capillary blood sample. The LMT-3000 ablates the epidermis and a thin layer of papillary dermis with minimal photothermal and photomechanical damage to the surrounding tissue.
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