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510(k) Data Aggregation

    K Number
    K240897
    Device Name
    Cellinew
    Manufacturer
    Date Cleared
    2024-11-26

    (239 days)

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

    Viol Co. Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Cellinew is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
    Device Description
    The CELLINEW generates radiofrequency(RF) energy by means of high RF at 6.78Mhz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction with is capable of coagulation the tissue. In detail, the main body uses the "reverse thermal gradient" principle to deliver RF energy, and thus, heat is generated and selective coagulation occurs while cooling the epidermis, resulting in denaturation and contraction of collagen fibers. The CELLINEW Device is a non-invasive device for coagulation using high frequency current. The device consists of a main body, handpiece, two disposable electrodes, a neutral electrode, neutral electrode cable, foot switch(optional) and power cord, and is controlled by software.
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