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510(k) Data Aggregation

    K Number
    K052310
    Device Name
    CRYOFLOW 700, CRYOFLOW 1000
    Date Cleared
    2006-03-15

    (203 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    **UNIPHY ELEKTROMEDIZIN GMBH **& CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Cryoflow 700 and Cryoflow 1000 are intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
    Device Description
    The Cryoflow 700 and Cryoflow 1000 consists of a refrigeration unit that creates cold air. The cold air is blown onto the skin using an air hose.
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