REG — Suntan Lamp Class II
FDA product code REG covers "Suntan Lamp", a Class II medical device regulated under 21 CFR 878.4635. Submissions are reviewed by the General, Plastic Surgery panel.
Classification Details
- Product Code
- REG
- Device Class
- Class II
- Regulation Number
- 878.4635
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- 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.