| Device Type ID | 5515 |
| Device Name | Light, Surgical, Floor Standing |
| Regulation Description | Surgical Lamp. |
| 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) Exempt |
| CFR Regulation Number | 878.4580 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FSS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5515 |
| Device | Light, Surgical, Floor Standing |
| Product Code | FSS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Lamp. |
| CFR Regulation Number | 878.4580 [🔎] |
| Device Problems | |
|---|---|
Material Disintegration | 3 |
Electrical /Electronic Property Problem | 3 |
Detachment Of Device Component | 2 |
Component Falling | 2 |
Thermal Decomposition Of Device | 1 |
Self-Activation Or Keying | 1 |
Device Tipped Over | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 14 |