FQP · Lamp, Operating-Room
General, Plastic Surgery · 21 CFR 878.4580 · Class 2
Overview
| Product Code | FQP |
|---|---|
| Device Name | Lamp, Operating-Room |
| Regulation | 21 CFR 878.4580 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K001223 | ACULUX, MODEL AX3001, AX3002 | Aculux | Jun 23, 2000 | SESE |
| K993314 | SYNTHES LIGHT GUIDE | Synthes (Usa) | Dec 6, 1999 | SESE |
| K781581 | SURGICAL LIGHT 22 SERIES | American Sterilizer Co. | Oct 17, 1978 | SESE |
| K770812 | HANDLES, LIGHT, SURGICAL, STEOILE | Sybron Corp. | May 23, 1977 | SESE |
| K761018 | SURGICAL LIGHT - CHALLENGE 22 SERIES | Amsco Co. | Jan 26, 1977 | SESE |
Top Applicants
- Synthes (Usa) — 1 clearance
- Sybron Corp. — 1 clearance
- Amsco Co. — 1 clearance
- American Sterilizer Co. — 1 clearance
- Aculux — 1 clearance
