Product code
OHS: Light based over the counter wrinkle reduction
FDA product code · Class II · General & Plastic Surgery
Key facts
| Product code | OHS |
|---|---|
| Device | Light based over the counter wrinkle reduction |
| Device class | Class II |
| Regulation number | 878.4810 |
| 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 | Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided. |
At a glance
- 100–999 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 100–999 UDI devices (GUDID)
- 100–999 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