Light, Surgical, Fiberoptic
FDA product code FST · Class II (moderate risk) · 21 CFR 878.4580 · General, Plastic Surgery
45510(k) clearances
0PMA approvals
12recalls
Manufacturers
- Advanced Surgical Products, Inc. 5
- Cuda Products Co. 3
- Medical Illumination International, Inc. 2
- Invuity, Inc. 2
- STERIS Corporation 2
- Sensormed 2
- Kirschner Medical Corp. 1
- Medtronic Xomed, Inc. 1
- Isolux America 1
- Products For Medicine 1
- Cogent Light Technologies, Inc. 1
- Infinitech, Inc. 1
- Woodbine Ptical Corp. 1
- Pilling Co. 1
- Innovasis, Inc. 1
- Pentax Precision Instrument Corp. 1
- Fiberoptic Medical Products, Inc. 1
- Orlux Engineering and Instrumentation 1
- M.P. Video, Inc. 1
- Trek Medical Products, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K200874 | TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With…FST · Traditional | Innovasis, Inc. | 06/30/2020SE |
| K141330 | Endo-CordFST · Traditional | Enroxtech, Inc. | 12/15/2014SE |
| K122637 | Lite Decompression System- Light Cable Model 48089999FST · Traditional | Stryker Spine | 11/01/2012SE |
| K113697 | Eigr Surgical Illumination SystemFST · Special | Invuity, Inc. | 02/10/2012SE |
| K113330 | CablecapFST · Traditional | Sensormed | 01/12/2012SE |
| K102266 | Isoled Ac-Powered LED Headlight SystemFST · Traditional | Isolux, LLC | 09/24/2010SE |
| K101496 | Cablecap Model: WLF, STZ, AcmFST · Traditional | Sensormed | 09/14/2010SE |
| K100388 | 21ST Century Centurion Exceled and System Two LED Lighting SystemsFST · Traditional | Medical Illumination International, Inc. | 06/22/2010SE |
| K100395 | Harmony Vled Surgical Lightning SystemFST · Special | STERIS Corporation | 03/17/2010SE |
| K093386 | Chromalume Turbo Light Source with Xtremebeam Fiber Optic Headlampfst Model FSTFST · Traditional | Bfw, Inc. | 01/28/2010SE |
| K090070 | Invuity Britefield Mcculloch Retractor SystemFST · Traditional | Invuity, Inc. | 04/22/2009SE |
| K083710 | Retractor LiteFST · Traditional | Thomas Surgical Instruments, Inc. | 02/23/2009SE |
| K082992 | Axxion Light GuideFST · Traditional | Spinal Elements, Inc. | 02/18/2009SE |
| K080962 | Lite Wand IIFST · Traditional | Thompson Surgical Instruments, Inc. | 06/25/2008SE |
| K080367 | Zimmer Mis LightFST · Traditional | Zimmer Spine, Inc. | 02/22/2008SE |
| K071218 | Proxenon 350, Model 902XXFST · Traditional | Welch Allyn, Inc. | 06/14/2007SE |
| K061690 | Surgical HeadlightFST · Traditional | Gulf Medical Fiberoptics | 09/15/2006SE |
| K053227 | Luxenon 150-300 Watt Medical Fiberoptic Light Source Illuminating Headlights…FST · Traditional | Medical Illumination International, Inc. | 01/13/2006SE |
| K051786 | Melide Fiberoptic LightFST · Special | Designs For Vision, Inc. | 08/15/2005SE |
| K042034 | Nuvasive Maxcess Light GuideFST · Traditional | Nuvasive, Inc. | 10/26/2004SE |
| K003577 | Steris Deepsite Fiber Optic Surgical LightFST · Abbreviated | STERIS Corporation | 01/29/2001SE |
| K000728 | Medtronic Solan Fiberoptic Corneal Light ProbeFST · Traditional | Medtronic Xomed | 03/21/2000SE |
| K991572 | Isolux Surgical HeadlightFST · Traditional | Isolux America | 07/08/1999SE |
| K972225 | Ufr Fiberoptic CableFST · Traditional | Universal Fiberoptic Repair, Inc. | 03/18/1998SE |
| K955510 | X6000D Silent Sun Light SourceFST · Traditional | Products For Medicine | 01/31/1996SE |
| K936048 | Lightwear(Tm) Syst (Lightwear Headlight Clip/Headband)FST · Traditional | Cogent Light Technologies, Inc. | 03/10/1994SE |
| K931546 | End-Irrigating EndoilluminatorFST · Traditional | Infinitech, Inc. | 02/09/1994SE |
| K922820 | Woodbine XT350, Xenon Arc Light SourceFST · Traditional | Woodbine Ptical Corp. | 09/02/1992SE |
| K922544 | Medicam 900 Autoelectronic Light SourceFST · Traditional | Kirschner Medical Corp. | 08/07/1992SE |
| K921646 | Nextec Fiberoptic Illuminator 300 Watt XenonFST · Traditional | Nextec Corp. | 05/13/1992SE |
| K915274 | Metal Halide Light Source Model LM 250FST · Traditional | Pentax Precision Instrument Corp. | 01/23/1992SE |
| K912252 | Infinity(R) Transilluminator Examination LightFST · Traditional | Fiberoptic Medical Products, Inc. | 06/27/1991SE |
| K903800 | Fiber Optic Light CableFST · Traditional | Orlux Engineering and Instrumentation | 08/29/1990SE |
| K901491 | Cuda Surgical LightFST · Traditional | Cuda Products Co. | 06/18/1990SE |
| K901035 | Fiber Optic Light Guide or Fiber Optic CableFST · Traditional | Cuda Products Co. | 04/23/1990SE |
| K893828 | ML-800 Autoelectronic Light SourceFST · Traditional | M.P. Video, Inc. | 07/24/1989SE |
| K893491 | Model M2-150/I-150/M2-150T/M3-150/M2-150,300-300FST · Traditional | Cuda Products Co. | 06/22/1989SE |
| K875007 | Prisma Dispos. Brite Lite Fiberoptic Endoillumina.FST · Traditional | Advanced Surgical Products, Inc. | 03/14/1988SE |
| K875006 | Prisma Disposa. Brite Lite Fiberoptic Endo. W/PickFST · Traditional | Advanced Surgical Products, Inc. | 03/14/1988SE |
| K875005 | Prisma Dispos. Brite Lite Fiberoptic Endoillumina.FST · Traditional | Advanced Surgical Products, Inc. | 03/14/1988SE |
| K875004 | Prisma Dispos. Brite Lite Fiberoptic Endo. W/PickFST · Traditional | Advanced Surgical Products, Inc. | 03/14/1988SE |
| K875195 | Ophthalmic Light Pipe PickFST · Traditional | Trek Medical Products, Inc. | 03/07/1988SE |
| K870942 | MVS Fiberoptic LightpipeFST · Traditional | Advanced Surgical Products, Inc. | 04/03/1987SE |
| K864380 | Lutex Headlight SystemsFST · Traditional | Luxtec Corp. | 11/19/1986SE |
| K761142 | Headlights W/ Filter-Optico CablesFST · Traditional | Pilling Co. | 01/05/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0930-2015 Class II | Harmony vLED Surgical Lighting System, one unit packaged per box The Harmony vLED…STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate… | Steris Corporation | 11/26/2014Terminated |
| Z-2029-2012 Class II | GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65 Replacement…The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm's 510k due… | Gulf Fiberoptics, Inc. | 04/09/2012Terminated |
| Z-0381-2012 | UltraLite Headlight module-grey Model: 001328 Product Usage: The fiber optic headlight…Headlight assembly (module) may become loose and separate from the headband assembly | Integra LifeSciences Corp. | 10/10/2011Terminated |
| Z-0380-2012 | Mark II Headlight module-black with short linkage Model: 001380LXSL Product Usage: The…Headlight assembly (module) may become loose and separate from the headband assembly | Integra LifeSciences Corp. | 10/10/2011Terminated |
| Z-0379-2012 | Mark II Headlight module-black Model: 001380LX Product Usage: The fiber optic headlight…Headlight assembly (module) may become loose and separate from the headband assembly | Integra LifeSciences Corp. | 10/10/2011Terminated |
| Z-0378-2012 | Luxtec UltraLite Headlight System sweatband with short linkage Model: AXI385BIFSL…Headlight assembly (module) may become loose and separate from the headband assembly | Integra LifeSciences Corp. | 10/10/2011Terminated |
| Z-0377-2012 | Luxtec UltraLite Headlight System sweatband Model: AXI385BIF Product Usage: The fiber…Headlight assembly (module) may become loose and separate from the headband assembly | Integra LifeSciences Corp. | 10/10/2011Terminated |
| Z-0376-2012 | Luxtec UltraLite Headlight System with short linkage Model: AX 1375BIFSL Product Usage:…Headlight assembly (module) may become loose and separate from the headband assembly | Integra LifeSciences Corp. | 10/10/2011Terminated |
| Z-0375-2012 | Luxtec UltraLite Headlight System Headband Model: AXI375BIF Product Usage: The fiber…Headlight assembly (module) may become loose and separate from the headband assembly | Integra LifeSciences Corp. | 10/10/2011Terminated |
| Z-0374-2012 | Luxtec UltraLite Headlight System with 9ft premium bifurcated cable Model: AX2100BIF…Headlight assembly (module) may become loose and separate from the headband assembly | Integra LifeSciences Corp. | 10/10/2011Terminated |
| Z-0373-2012 | Luxtec UltraLite Pro Headlight with 9ft bifurcated cable Model: AX2000BIF Product Usage:…Headlight assembly (module) may become loose and separate from the headband assembly | Integra LifeSciences Corp. | 10/10/2011Terminated |
| Z-0831-2012 | Surgical Headlight labeled in part *Gulf Medical Fiberoptics*OLDSMAR, FLORIDA U.S.A.*…Gulf Medical Fiberoptics, Inc. recalled their Surgical Headlight because the cleaning instructions for the… | Gulf Medical Fiberoptics, Inc. | 05/13/2011Terminated |