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510(k) Data Aggregation

    K Number
    K222356
    Device Name
    Claritag Advanced
    Manufacturer
    DGI Technologies
    Date Cleared
    2023-05-18

    (287 days)

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

    DGI Technologies

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Claritag Advanced is intended for the OTC treatment of skin tags in adults age 21 years or older.
    Device Description
    The Claritag Advanced is a portable, hand operated device intended for use in the treatment of skin tag removal using a cryogen application system. The Claritag Kit contains the Claritag handheld device and the Claritag Base. The Claritag device houses the Claritag "squeeze and freeze" heads with foam treatment pads and liquid cooling gas. A spare set of treatment heads is included. The Claritag Base will activate the freezing once the heads are placed into the base. Pressing down on the base sends the liquid cooling gas to the Claritag "squeeze and freeze heads." Instructions for Use are included.
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    K Number
    K190747
    Device Name
    Claritag
    Manufacturer
    DGI Technologies
    Date Cleared
    2019-10-31

    (223 days)

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

    DGI Technologies

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Claritag is indicated for use in the treatment of achrochordons (skin tags).
    Device Description
    The Claritag device is indicated for the treatment of skin tags. Claritag® is a portable, hand operated device intended for use in the treatment of skin tag removal using a cryogen application system. The cryogen application methodology for skin tag removal is a widely accepted practice used by physicians for decades. The Claritag device is provided in a kit containing the main device (canister containing aerosolized cryogen, fitted with two treatment head activation base, 20 disposal single use foam pads, tweezers (which are provided as an optional accessory) and Instructions for Use. The mechanism of action for cryotherapy are the direct effects of freezing on the cells, and the vascular stasis which develops in the tissue after thawing.
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