FST — Light, Surgical, Fiberoptic Class II
FDA product code FST covers "Light, Surgical, Fiberoptic", a Class II medical device regulated under 21 CFR 878.4580. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |