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510(k) DEN220078

Eroxon by Futura Medical Developments Limited — Product Code QWW

DEN220078 is an FDA 510(k) premarket notification submitted by Futura Medical Developments Limited for the device "Eroxon". The FDA issued a decision of De Novo granted on Jun 9, 2023. The device falls under product code QWW (Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.), a Class II device regulated under 21 CFR 876.5021.

Clearance Details

Decision
DENG (De Novo granted)
Decision Date
Jun 9, 2023
Date Received
Oct 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
510(k)

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.

FDA data resources