Definition: A Sunlamp Product Assembled Or Manufactured Before November 9, 1979. These Are Class II Medical Devices As Of 2014.
| Device Type ID | 5911 |
| Device Name | Sunlamp Products (pre-standard) |
| Physical State | Lamp / Tanning Bed With Lamp |
| Technical Method | The Lamp Is Directed At The Skin |
| Target Area | Skin |
| 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 | RAB |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5911 |
| Device | Sunlamp Products (pre-standard) |
| Product Code | RAB |
| 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 [🔎] |