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510(k) Data Aggregation

    K Number
    K243533
    Device Name
    Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus
    Manufacturer
    HLB Co., Ltd. Healthcare
    Date Cleared
    2025-01-13

    (59 days)

    Product Code
    FMK, ORK
    Regulation Number
    878.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    HLB Co., Ltd. Healthcare

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is intended for capillary blood sampling.
    Device Description
    The Sterilized Eol Auto Lancet and Sterilized Eol Lancet Plus are single-use, surgical steel devices housed in plastic, designed to puncture a fingertip for capillary blood sampling. They can be used anytime and anywhere to measure blood glucose levels in diabetic patients. The needle sleeve serves as a sterile barrier, sterilized to an SAL of 10-6 through irradiation. The product has a shelf life of 3 years. The Sterilized Eol Auto Lancet includes a protective cap, handle, needle, button, lancing device, and two springs. To activate, simply remove the protective cap, place the button on the skin, and press the lancet. After use, the needle retracts into the device for safe handling. The Sterilized Eol Lancet Plus includes a protective cap, handle, and needle. It can be used alone or with a lancing device that offers an adjustable tip and varying depth settings.
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