HJE · Lamp, Fluorescein, Ac-Powered
General, Plastic Surgery · 21 CFR 878.4580 · Class 2
Overview
| Product Code | HJE |
|---|---|
| Device Name | Lamp, Fluorescein, Ac-Powered |
| Regulation | 21 CFR 878.4580 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
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.
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.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K922348 | VALTRAC(R) INTRODUCER FORCEP | American Cyanamid Co. | Jun 9, 1992 | SESE |
| K802291 | FLUORESCENT SUN LAMP FIXTURE | Strato-Ray Co. | Oct 31, 1980 | SESE |
| K781698 | EXAMINER 10 | American Sterilizer Co. | Nov 3, 1978 | SESE |
Top Applicants
- American Cyanamid Co. — 1 clearance
- American Sterilizer Co. — 1 clearance
- Strato-Ray Co. — 1 clearance
