510(k) DEN220078
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 June 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
- 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.