FST · Light, Surgical, Fiberoptic
General, Plastic Surgery · 21 CFR 878.4580 · Class 2
Overview
| Product Code | FST |
|---|---|
| Device Name | Light, Surgical, Fiberoptic |
| 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.
Cleared Devices (45)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K200874 | TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End | Innovasis, Inc. | Jun 30, 2020 | SESE |
| K141330 | ENDO-CORD | Enroxtech, Inc. | Dec 15, 2014 | SESE |
| K122637 | LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999 | Stryker Spine | Nov 1, 2012 | SESE |
| K113697 | EIGR SURGICAL ILLUMINATION SYSTEM | Invuity, Inc. | Feb 10, 2012 | SESE |
| K113330 | CABLECAP | Sensormed | Jan 12, 2012 | SESE |
| K102266 | ISOLED AC-POWERED LED HEADLIGHT SYSTEM | Isolux, LLC | Sep 24, 2010 | SESE |
| K101496 | CABLECAP MODEL: WLF, STZ, ACM | Sensormed | Sep 14, 2010 | SESE |
| K100388 | 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS | Medical Illumination International, Inc. | Jun 22, 2010 | SESE |
| K100395 | HARMONY VLED SURGICAL LIGHTNING SYSTEM | STERIS Corporation | Mar 17, 2010 | SESE |
| K093386 | CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST | Bfw, Inc. | Jan 28, 2010 | SESE |
| K090070 | INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM | Invuity, Inc. | Apr 22, 2009 | SESE |
| K083710 | RETRACTOR LITE | Thomas Surgical Instruments, Inc. | Feb 23, 2009 | SESE |
| K082992 | AXXION LIGHT GUIDE | Spinal Elements, Inc. | Feb 18, 2009 | SESE |
| K080962 | LITE WAND II | Thompson Surgical Instruments, Inc. | Jun 25, 2008 | SESE |
| K080367 | ZIMMER MIS LIGHT | Zimmer Spine, Inc. | Feb 22, 2008 | SESE |
| K071218 | PROXENON 350, MODEL 902XX | Welch Allyn, Inc. | Jun 14, 2007 | SESE |
| K061690 | SURGICAL HEADLIGHT | Gulf Medical Fiberoptics | Sep 15, 2006 | SESE |
| K053227 | LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES | Medical Illumination International, Inc. | Jan 13, 2006 | SESE |
| K051786 | MELIDE FIBEROPTIC LIGHT | Designs For Vision, Inc. | Aug 15, 2005 | SESE |
| K042034 | NUVASIVE MAXCESS LIGHT GUIDE | Nuvasive, Inc. | Oct 26, 2004 | SESE |
| K003577 | STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT | STERIS Corporation | Jan 29, 2001 | SESE |
| K000728 | MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE | Medtronic Xomed | Mar 21, 2000 | SESE |
| K991572 | ISOLUX SURGICAL HEADLIGHT | Isolux America | Jul 8, 1999 | SESE |
| K972225 | UFR FIBEROPTIC CABLE | Universal Fiberoptic Repair, Inc. | Mar 18, 1998 | SESE |
| K955510 | X6000D SILENT SUN LIGHT SOURCE | Products For Medicine | Jan 31, 1996 | SESE |
| K936048 | LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND) | Cogent Light Technologies, Inc. | Mar 10, 1994 | SESE |
| K931546 | END-IRRIGATING ENDOILLUMINATOR | Infinitech, Inc. | Feb 9, 1994 | SESE |
| K922820 | WOODBINE XT350, XENON ARC LIGHT SOURCE | Woodbine Ptical Corp. | Sep 2, 1992 | SESE |
| K922544 | MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE | Kirschner Medical Corp. | Aug 7, 1992 | SESE |
| K921646 | NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON | Nextec Corp. | May 13, 1992 | SESE |
| K915274 | METAL HALIDE LIGHT SOURCE MODEL LM 250 | Pentax Precision Instrument Corp. | Jan 23, 1992 | SESE |
| K912252 | INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT | Fiberoptic Medical Products, Inc. | Jun 27, 1991 | SESE |
| K903800 | FIBER OPTIC LIGHT CABLE | Orlux Engineering and Instrumentation | Aug 29, 1990 | SESE |
| K901491 | CUDA SURGICAL LIGHT | Cuda Products Co. | Jun 18, 1990 | SESE |
| K901035 | FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE | Cuda Products Co. | Apr 23, 1990 | SESE |
| K893828 | ML-800 AUTOELECTRONIC LIGHT SOURCE | M.P. Video, Inc. | Jul 24, 1989 | SESE |
| K893491 | MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300 | Cuda Products Co. | Jun 22, 1989 | SESE |
| K875007 | PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA. | Advanced Surgical Products, Inc. | Mar 14, 1988 | SESE |
| K875006 | PRISMA DISPOSA. BRITE LITE FIBEROPTIC ENDO. W/PICK | Advanced Surgical Products, Inc. | Mar 14, 1988 | SESE |
| K875005 | PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA. | Advanced Surgical Products, Inc. | Mar 14, 1988 | SESE |
| K875004 | PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK | Advanced Surgical Products, Inc. | Mar 14, 1988 | SESE |
| K875195 | OPHTHALMIC LIGHT PIPE PICK | Trek Medical Products, Inc. | Mar 7, 1988 | SESE |
| K870942 | MVS FIBEROPTIC LIGHTPIPE | Advanced Surgical Products, Inc. | Apr 3, 1987 | SESE |
| K864380 | LUTEX HEADLIGHT SYSTEMS | Luxtec Corp. | Nov 19, 1986 | SESE |
| K761142 | HEADLIGHTS W/ FILTER-OPTICO CABLES | Pilling Co. | Jan 5, 1977 | SESE |
Top Applicants
- Advanced Surgical Products, Inc. — 5 clearances
- Cuda Products Co. — 3 clearances
- Sensormed — 2 clearances
- STERIS Corporation — 2 clearances
- Medical Illumination International, Inc. — 2 clearances
