FSW · Light, Surgical, Endoscopic
General, Plastic Surgery · 21 CFR 878.4580 · Class 2
Overview
| Product Code | FSW |
|---|---|
| Device Name | Light, Surgical, Endoscopic |
| 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.
Cleared Devices (8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K022989 | RADLITE TISSUE RETRACTOR SYSTEM | Genzyme Biosurgery | Nov 25, 2002 | SESE |
| K013511 | XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) | Aculux, Inc. | Feb 1, 2002 | SESE |
| K943342 | MEDICAM XENON LIGHT SOURCE | M.P. Video, Inc. | Oct 17, 1994 | SESE |
| K934337 | CUDA PRODUCTS CORP. MODEL MX2-300 LIGHTSOURCE | Cuda Products Co. | Nov 18, 1993 | SESE |
| K922279 | ILLUMINATOR IV MINOR SURGERY LIGHT | Medical Illumination, Inc. | Sep 2, 1992 | SESE |
| K913135 | LM-300TWIN | Leisegang Medical, Inc. | Sep 18, 1991 | SESE |
| K894319 | MEDICAL DYNAMICS LIGHT SOURCE | Medical Dynamics, Inc. | Oct 3, 1989 | SESE |
| K870898 | ULTRA-LUX LIGHT SOURCE | Medline Industries, Inc. | Mar 18, 1987 | SESE |
Top Applicants
- Medline Industries, Inc. — 1 clearance
- Medical Illumination, Inc. — 1 clearance
- Medical Dynamics, Inc. — 1 clearance
- M.P. Video, Inc. — 1 clearance
- Leisegang Medical, Inc. — 1 clearance
