FDA product code QVX: Skin Patch For Treatment Of Hyperhidrosis
QVX is the FDA product code for skin patch for treatment of hyperhidrosis. It is a Class II device, regulated under 21 CFR 878.4425 and reviewed by the General and Plastic Surgery panel. Devices under QVX reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Skin Patch For Treatment Of Hyperhidrosis |
| Device class | Class II |
| Regulation | 21 CFR 878.4425 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Recalls for QVX devices
openFDA lists no recalls for product code QVX.
Frequently asked questions
What is FDA product code QVX?
QVX is the FDA product code for skin patch for treatment of hyperhidrosis. It is a Class II device, regulated under 21 CFR 878.4425 and reviewed by the General and Plastic Surgery panel.
What device class is QVX?
Class II, regulation 21 CFR 878.4425. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QVX
- Run a recall and safety report across every QVX manufacturer
- Watch product code QVX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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