X6000D SILENT SUN LIGHT SOURCE
Device Facts
| Record ID | K955510 |
|---|---|
| Device Name | X6000D SILENT SUN LIGHT SOURCE |
| Applicant | Products For Medicine |
| Product Code | FST · General, Plastic Surgery |
| Decision Date | Jan 31, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4580 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.
Special Controls
*Classification.* Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
