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510(k) Data Aggregation

    K Number
    DEN220078
    Device Name
    Eroxon
    Date Cleared
    2023-06-09

    (231 days)

    Product Code
    Regulation Number
    876.5021
    Why did this record match?
    Product Code :

    QWW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Treatment of erectile dysfunction in adult males aged 22 years and over.
    Device Description
    Eroxon is a non-medicated, hydro-alcoholic gel formulation for topical application to the glans penis prior to sexual intercourse. Eroxon is intended as a topical treatment for male erectile dysfunction, which is the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. Upon application, Eroxon stimulates blood flow through the penis. The volatile components of the formulation (alcohol, water) evaporate to create a rapid, localized cooling effect on the glans penis followed by a recovering slower warming effect. This stimulates nerve endings leading to tumescence and erection. Eroxon is supplied in single-dose aluminum tubes. Each tube is designed to dispense approximately 300 mg of gel. The device is supplied non-sterile and is for single use only.
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