REH — Tabletop Sunlamp System Class II
FDA product code REH covers "Tabletop Sunlamp System", a Class II medical device regulated under 21 CFR 878.4635. Submissions are reviewed by the General, Plastic Surgery panel.
Classification Details
- Product Code
- REH
- Device Class
- Class II
- Regulation Number
- 878.4635
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.