FST — Light, Surgical, Fiberoptic Class II
FDA Device Classification
Classification Details
- Product Code
- FST
- Device Class
- Class II
- Regulation Number
- 878.4580
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K200874 | innovasis | TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cab | June 30, 2020 |
| K141330 | enroxtech | ENDO-CORD | December 15, 2014 |
| K122637 | stryker spine | LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999 | November 1, 2012 |
| K113697 | invuity | EIGR SURGICAL ILLUMINATION SYSTEM | February 10, 2012 |
| K113330 | sensormed | CABLECAP | January 12, 2012 |
| K102266 | isolux | ISOLED AC-POWERED LED HEADLIGHT SYSTEM | September 24, 2010 |
| K101496 | sensormed | CABLECAP MODEL: WLF, STZ, ACM | September 14, 2010 |
| K100388 | medical illumination international | 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS | June 22, 2010 |
| K100395 | steris corporation | HARMONY VLED SURGICAL LIGHTNING SYSTEM | March 17, 2010 |
| K093386 | bfw | CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST | January 28, 2010 |
| K090070 | invuity | INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM | April 22, 2009 |
| K083710 | thomas surgical instruments | RETRACTOR LITE | February 23, 2009 |
| K082992 | spinal elements | AXXION LIGHT GUIDE | February 18, 2009 |
| K080962 | thompson surgical instruments | LITE WAND II | June 25, 2008 |
| K080367 | zimmer spine | ZIMMER MIS LIGHT | February 22, 2008 |
| K071218 | welch allyn | PROXENON 350, MODEL 902XX | June 14, 2007 |
| K061690 | gulf medical fiberoptics | SURGICAL HEADLIGHT | September 15, 2006 |
| K053227 | medical illumination international | LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SP | January 13, 2006 |
| K051786 | designs for vision | MELIDE FIBEROPTIC LIGHT | August 15, 2005 |
| K042034 | nuvasive | NUVASIVE MAXCESS LIGHT GUIDE | October 26, 2004 |