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510(k) DEN220078

Eroxon by Futura Medical Developments Limited — Product Code QWW

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: June 9, 2023
Date Received: October 21, 2022
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.
Device Class: Class II
Regulation Number: 876.5021
Review Panel: GU
Submission Type

A non-medicated topical formulation for treatment of erectile dysfunction is a device that is applied on the penis and stimulates the nerve endings by inducing a temperature change, leading to tumescence and erection.