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510(k) Data Aggregation
K Number
DEN220078Device Name
Eroxon
Manufacturer
Date Cleared
2023-06-09
(231 days)
Regulation Number
876.5021Why 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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