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510(k) Data Aggregation

    K Number
    K221897
    Device Name
    Hydrozid Precise
    Manufacturer
    BIBAWO Medical A/S
    Date Cleared
    2023-05-30

    (334 days)

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

    BIBAWO Medical A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Hydrozid Precise contains 1.1.1.2-tetrafluoroethane (also known as R134A, HFC-134a, HFA-134a or fluorocarbon 134a) and is to be used for the treatment of vertuca (warts), including plantar warts, seborrheic keratosis, acrochordon (skin tags), molluscum contagiosum, age spots (lentigo), dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chondrodermatits, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyogenic granuloma.
    Device Description
    Hydrozid Precise™ is a portable aerosol cryosurgery device intended for the treatment of benign and premalignant skin lesions using a cryogen to freeze cells to induce necrosis (cell destruction). The main device component is the aerosol canister containing cryogen spray. The device is provided in a kit containing a canister, application templates and Instructions for Use. The device is used with non-sterile, single-patient application templates which are disposed after use.
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