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-NumberApplicantDevice NameDate
K200874innovasisTruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light CabJune 30, 2020
K141330enroxtechENDO-CORDDecember 15, 2014
K122637stryker spineLITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999November 1, 2012
K113697invuityEIGR SURGICAL ILLUMINATION SYSTEMFebruary 10, 2012
K113330sensormedCABLECAPJanuary 12, 2012
K102266isoluxISOLED AC-POWERED LED HEADLIGHT SYSTEMSeptember 24, 2010
K101496sensormedCABLECAP MODEL: WLF, STZ, ACMSeptember 14, 2010
K100388medical illumination international21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMSJune 22, 2010
K100395steris corporationHARMONY VLED SURGICAL LIGHTNING SYSTEMMarch 17, 2010
K093386bfwCHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FSTJanuary 28, 2010
K090070invuityINVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEMApril 22, 2009
K083710thomas surgical instrumentsRETRACTOR LITEFebruary 23, 2009
K082992spinal elementsAXXION LIGHT GUIDEFebruary 18, 2009
K080962thompson surgical instrumentsLITE WAND IIJune 25, 2008
K080367zimmer spineZIMMER MIS LIGHTFebruary 22, 2008
K071218welch allynPROXENON 350, MODEL 902XXJune 14, 2007
K061690gulf medical fiberopticsSURGICAL HEADLIGHTSeptember 15, 2006
K053227medical illumination internationalLUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPJanuary 13, 2006
K051786designs for visionMELIDE FIBEROPTIC LIGHTAugust 15, 2005
K042034nuvasiveNUVASIVE MAXCESS LIGHT GUIDEOctober 26, 2004