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    K Number
    K243176
    Device Name
    BLESSING System
    Manufacturer
    Cellah Medical Co., Ltd.
    Date Cleared
    2025-05-16

    (228 days)

    Product Code
    GEI, OUH
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cellah Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BLESSING System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
    Device Description
    The device is used for coagulation through high-frequency current and consists of a main body, three types of handpieces, a handpiece stand, an electrode, a neutral (counter) electrode, a counter electrode connection cable, a foot switch, and a power cord, all controlled by software. It works on the principle that skin tissue coagulates due to heat generated by the load or contact resistance when high-frequency (RF) energy is applied to the tissue.
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