QVX — Skin Patch For Treatment Of Hyperhidrosis Class II
FDA product code QVX covers "Skin Patch For Treatment Of Hyperhidrosis", a Class II medical device regulated under 21 CFR 878.4425. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QVX
- Device Class
- Class II
- Regulation Number
- 878.4425
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
A skin patch for treatment of hyperhidrosis is a prescription topical patch that utilizes a chemical reaction to generate thermal energy in situ for treatment of hyperhidrosis.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN210055 | candesant biomedical | The N-SWEAT Patch | April 7, 2023 |