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510(k) Data Aggregation

    K Number
    K072883
    Device Name
    ICE-SENSE
    Manufacturer
    ARBEL MEDICAL LTD.
    Date Cleared
    2007-12-10

    (62 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARBEL MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Urology - The system may be used to ablate prostatic tissue. . - . The system may be used for the ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia Oncology - The system may be used for ablation of cancerous or malignant tissue. . - The system may be used for ablation of benign tumors. . - The system may be used for palliative intervention. . Dermatology - The system may be used for the ablation or freezing of skin cancers and other . cutaneous disorders. Gynecology - The system may be used for the ablation of malignant neoplasia or benign . dysplasia of the female genitalia. General Surgery - The system may be used for the ablation of leukoplakia of mouth, angiomas, . sebaceous hyperplasia, basal cell tumors of the evelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions. - The system may be used for the destruction of warts or lesions. . - . The system may be used for the palliation of tumors of the oral cavity, rectum, and skin. Thoracic Surgery - The system may be used for the ablation of arrhythmic cardiac tissue. . The system may be used for the ablation of cancerous lesions . Proctologv - . The system may be used for the ablation of benign or malignant growths of the anus and rectum - . The systems may be used for the ablation of hemorrhoids.
    Device Description
    The ICE-SENSE™ Device is used to destroy unwanted tissue by application of extreme cold to the selected site. The device delivers cold temperatures to targeted tissue by pressurized liquid nitrogen closed system and a disposable sharp or blunt probes. The device consists of a main chassis for the cooling system, a controller with a screen and key pad, a cryohandle that controls and holds the probe and a foot pedal.
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