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.
| Device Type ID | 5913 |
| Device Name | Suntan Lamp |
| 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 | REG |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 5913 |
| Device | Suntan Lamp |
| Product Code | REG |
| 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 |