| Device Type ID | 5514 |
| Device Name | Light, Surgical, Instrument |
| 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 | FSQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5514 |
| Device | Light, Surgical, Instrument |
| Product Code | FSQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Lamp. |
| CFR Regulation Number | 878.4580 [🔎] |
| Device Problems | |
|---|---|
Mechanical Problem | 2 |
Detachment Of Device Or Device Component | 1 |
Unintended Movement | 1 |
Device Tipped Over | 1 |
| Total Device Problems | 5 |