| Device Type ID | 5520 |
| Device Name | Light, Surgical, Carrier |
| 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 Two - Surgical (GSDB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4580 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FSZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5520 |
| Device | Light, Surgical, Carrier |
| Product Code | FSZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Lamp. |
| CFR Regulation Number | 878.4580 [🔎] |
| Device Problems | |
|---|---|
Overheating Of Device | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 2 |