Product code
REG: Suntan lamp
FDA product code · Class II · General & Plastic Surgery
Key facts
| Product code | REG |
|---|---|
| Device | Suntan lamp |
| Device class | Class II |
| Regulation number | 878.4635 |
| 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 | A lamp that produces ultraviolet radiation in the wavelength range of 200 to 400 nanometers in air and that is intended for use in any sunlamp product or fixture. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- 1–9 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