Product code
PKT: Laser for disruption of adipocyte cells for aesthetic use
FDA product code · Class II · General & Plastic Surgery
Key facts
| Product code | PKT |
|---|---|
| Device | Laser for disruption of adipocyte cells for aesthetic use |
| Device class | Class II |
| Regulation number | 878.5400 |
| Review panel | General & Plastic Surgery |
| Medical specialty | General & Plastic Surgery |
| Submission type | 510(k) |
| GMP exempt | Yes |
| Definition | Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas. |
At a glance
- 10–99 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 10–99 MAUDE adverse event reports
- None 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