QVX · Skin Patch For Treatment Of Hyperhidrosis
General, Plastic Surgery · 21 CFR 878.4425 · Class 2
Overview
| Product Code | QVX |
|---|---|
| Device Name | Skin Patch For Treatment Of Hyperhidrosis |
| Regulation | 21 CFR 878.4425 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
A semi-automated autologous skin graft harvesting and application device is a handheld electromechanical surgical instrument that extracts autologous skin graft tissue from a healthy donor skin site and deposits it to a recipient site. The device extraction and deposition functions are automated and are activated by the user. The device is intended for the harvesting and application of autologous, full-thickness skin micrografts for wounds where autologous skin grafting would be appropriate, excluding full-thickness burns.
Classification Rationale
Class II (special controls). The device is classified as Class II because the probable benefits outweigh the probable risks, and the risks can be mitigated using general controls and the identified special controls.
Special Controls
In combination with general controls of the Food Drug & Cosmetic Act, a skin patch for treatment of hyperhidrosis is subject to the following special controls:
In combination with the general controls of the FD&C Act, the semi-automated autologous skin graft harvesting and application device is subject to the following special controls:
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN210055 | The N-SWEAT Patch | Candesant Biomedical, Inc. | Apr 7, 2023 | DENG |
Top Applicants
- Candesant Biomedical, Inc. — 1 clearance
