FDA product code REH: Tabletop Sunlamp System
REH is the FDA product code for tabletop sunlamp system. It is a Class II device, regulated under 21 CFR 878.4635 and reviewed by the General and Plastic Surgery panel. Devices under REH reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
A sunlamp system that sits on a table, primarily intended to tan the face by ultraviolet radiation with wavelengths in air between 200 and 400 nanometers.
Classification
| Field | Value |
|---|---|
| Device name | Tabletop Sunlamp System |
| Device class | Class II |
| Regulation | 21 CFR 878.4635 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for REH devices
openFDA lists no recalls for product code REH.
Frequently asked questions
What is FDA product code REH?
REH is the FDA product code for tabletop sunlamp system. It is a Class II device, regulated under 21 CFR 878.4635 and reviewed by the General and Plastic Surgery panel.
What device class is REH?
Class II, regulation 21 CFR 878.4635. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code REH
- Run a recall and safety report across every REH manufacturer
- Watch product code REH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times