Definition: A Bed Or Other Platform That Is Designed To Incorporate One Or More Ultraviolet Lamps And Intended For Irradiation Of Any Part Of The Human Body, By Ultraviolet Radiation With Wavelengths In Air Between 200 And 400 Nanometers, To Induce Skin Tanning.
| Device Type ID | 5912 |
| Device Name | Suntan Bed |
| Regulation Description | Sunlamp Products And Ultraviolet Lamps Intended For Use In Sunlamp Products. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4635 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | REF |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5912 |
| Device | Suntan Bed |
| Product Code | REF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Sunlamp Products And Ultraviolet Lamps Intended For Use In Sunlamp Products. |
| CFR Regulation Number | 878.4635 [🔎] |
| Device Problems | |
|---|---|
Device Operational Issue | 1 |
| Total Device Problems | 1 |