Product code
OUP: Powered surgical instrument for improvement in the appearance of cellulite
FDA product code · Class II · General & Plastic Surgery
Key facts
| Product code | OUP |
|---|---|
| Device | Powered surgical instrument for improvement in the appearance of cellulite |
| Device class | Class II |
| Regulation number | 878.4790 |
| Review panel | General & Plastic Surgery |
| Medical specialty | General & Plastic Surgery |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite. |
At a glance
- 1–9 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database