| Device Type ID | 5667 |
| Device Name | Illuminator, Fiberoptic, Surgical Field |
| 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) |
| CFR Regulation Number | 878.4580 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HBI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5667 |
| Device | Illuminator, Fiberoptic, Surgical Field |
| Product Code | HBI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Lamp. |
| CFR Regulation Number | 878.4580 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ISOLUX LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KATALYST SURGICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Fire | 2 |
Sparking | 2 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Smoking | 1 |
Electrical Shorting | 1 |
Break | 1 |
| Total Device Problems | 8 |