FSS · Light, Surgical, Floor Standing
General, Plastic Surgery · 21 CFR 878.4580 · Class 2
Overview
| Product Code | FSS |
|---|---|
| Device Name | Light, Surgical, Floor Standing |
| 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 (20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K091246 | ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M) | Trumpf Medizin Systeme GmbH + Co. KG | Sep 28, 2009 | SESE |
| K003489 | NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8 | Medical Illumination International, Inc. | Feb 2, 2001 | SESE |
| K984124 | AESCULAP XENON LIGHT SOURCE | Aesculap, Inc. | Feb 1, 1999 | SESE |
| K981962 | CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE | Cuda Products Co. | Aug 18, 1998 | SESE |
| K981821 | VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR | Angiolaz, Inc. | Jul 29, 1998 | SESE |
| K981469 | CERMAX300 LIGHTSOURCE | Cuda Products Co. | Jul 9, 1998 | SESE |
| K980044 | XENON 300MX | Perkinelmer Optoelectronics | Apr 3, 1998 | SESE |
| K970886 | HANAULUX BLUE 80 HOSPITAL | Heraeus Med GmbH | Apr 16, 1997 | SESE |
| K961971 | Q-5000 | Stryker Endoscopy | Jun 28, 1996 | SESE |
| K961074 | LIGHTSOURCE OR ILLUMINATOR | Cuda Products Co. | Apr 30, 1996 | SESE |
| K930711 | TRI*STAR | Light Technology Systems | Jul 30, 1993 | SESE |
| K910942 | AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT | Mdt Biologic Co. | Jun 11, 1991 | SESE |
| K895950 | MODEL FEL5100 FLOOR LIGHT | F.W. Lang Co. | Oct 31, 1989 | SESE |
| K893813 | FLOOR STANDING, OPERATING AND EXAMINING LIGHT | Astralite Corp. | Jul 14, 1989 | SESE |
| K891759 | KINETIC MODEL 330 | Kinetic Biomedical Services, Inc. | Apr 19, 1989 | SESE |
| K891758 | KINETIC MODEL 132 | Kinetic Biomedical Services, Inc. | Apr 19, 1989 | SESE |
| K882333 | FLOOR LIGHT | Commercial Products & Engineering Co. | Jun 23, 1988 | SESE |
| K880540 | LIGHT, SURGICAL, FLOOR STANDING | Ferguson Medical | Feb 24, 1988 | SESE |
| K880198 | GEMINI SURGICAL LIGHT | American Sterilizer Co. | Feb 10, 1988 | SESE |
| K860020 | MINOR SURGERY LIGHT MODEL 2112 | Adel Medical , Ltd. | Jan 24, 1986 | SESE |
Top Applicants
- Cuda Products Co. — 3 clearances
- Kinetic Biomedical Services, Inc. — 2 clearances
- Trumpf Medizin Systeme GmbH + Co. KG — 1 clearance
- Stryker Endoscopy — 1 clearance
- Perkinelmer Optoelectronics — 1 clearance
