QWW · Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.
Gastroenterology, Urology · 21 CFR 876.5021 · Class 2
Overview
| Product Code | QWW |
|---|---|
| Device Name | Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction. |
| Regulation | 21 CFR 876.5021 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
A non-medicated topical formulation for treatment of erectile dysfunction. Eroxon is a hydro-alcoholic gel applied to the glans penis that stimulates nerve endings via a rapid cooling effect followed by a warming effect, leading to tumescence and erection. It is intended for the treatment of erectile dysfunction in adult males aged 22 years and over.
Classification Rationale
Class II (special controls). The device is subject to general controls and the identified special controls to mitigate risks such as failure to identify the correct population, deleterious effects on condoms, adverse tissue reactions, and pain or discomfort.
Special Controls
In combination with general controls of the Food Drug & Cosmetic Act, a non-medicated topical formulation for treatment of erectile dysfunction is subject to the following special controls:
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN220078 | Eroxon | Futura Medical Developments Limited | Jun 9, 2023 | DENG |
Top Applicants
- Futura Medical Developments Limited — 1 clearance
