FSQ · Light, Surgical, Instrument
General, Plastic Surgery · 21 CFR 878.4580 · Class 2
Overview
| Product Code | FSQ |
|---|---|
| Device Name | Light, Surgical, Instrument |
| 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 (7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K932139 | LIGHTED INTUBATION STYLET W/REPLACEABLE SHAFT | Aaron Medical Industries | Jul 30, 1993 | SESE |
| K930686 | MIDMARK SURGICAL LIGHTING SYSTEMS | Midmark Corp. | Jul 30, 1993 | SESE |
| K922409 | ALM ILLUMINATOR SERIES LIGHT SYSTEM | Alm Surgical Equipment, Inc. | Jan 12, 1993 | SESE |
| K921848 | BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT | Alm Surgical Equipment, Inc. | Oct 1, 1992 | SESE |
| K803067 | SURG-FLEX 10 LIGHT | Medical Products Development, Inc. | Feb 26, 1981 | SESE |
| K810019 | SURG-FLEX 15 SURGICAL LIGHT | Medical Products Development, Inc. | Jan 23, 1981 | SESE |
| K810018 | SURG-FLEX 5 SURGICAL LIGHT | Medical Products Development, Inc. | Jan 23, 1981 | SESE |
Top Applicants
- Medical Products Development, Inc. — 3 clearances
- Alm Surgical Equipment, Inc. — 2 clearances
- Midmark Corp. — 1 clearance
- Aaron Medical Industries — 1 clearance
