Product code FST— General, Plastic Surgery
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
- Classification name
- Light, Surgical, Fiberoptic
- Device class
- Class 2
- Regulation
- 21 CFR 878.4580
- Advisory panel
- General, Plastic Surgery
- Total cleared
- 45
- First cleared
- Most recent
Market context for product code FST
FDA has cleared devices under product code FST between 1977 and 2020, filed by 35 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2020
- 2014
- 2012
- 2010
- 2009
- 2008
- 2007
- 2006
- 2005
- 2004
- 2001
- 2000
- 1999
- 1998
- 1996
Top applicants under product code FST
Recent clearances under product code FST
- K200874 — TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End
- K141330 — ENDO-CORD
- K122637 — LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999
- K113697 — EIGR SURGICAL ILLUMINATION SYSTEM
- K113330 — CABLECAP
- K102266 — ISOLED AC-POWERED LED HEADLIGHT SYSTEM
- K101496 — CABLECAP MODEL: WLF, STZ, ACM
- K100388 — 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS
- K100395 — HARMONY VLED SURGICAL LIGHTNING SYSTEM
- K093386 — CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST
- K090070 — INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM
- K083710 — RETRACTOR LITE
- K082992 — AXXION LIGHT GUIDE
- K080962 — LITE WAND II
- K080367 — ZIMMER MIS LIGHT
- K071218 — PROXENON 350, MODEL 902XX
- K061690 — SURGICAL HEADLIGHT
- K053227 — LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES
- K051786 — MELIDE FIBEROPTIC LIGHT
- K042034 — NUVASIVE MAXCESS LIGHT GUIDE
- K003577 — STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT
- K000728 — MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE
- K991572 — ISOLUX SURGICAL HEADLIGHT
- K972225 — UFR FIBEROPTIC CABLE
- K955510 — X6000D SILENT SUN LIGHT SOURCE
- K936048 — LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND)
- K931546 — END-IRRIGATING ENDOILLUMINATOR
- K922820 — WOODBINE XT350, XENON ARC LIGHT SOURCE
- K922544 — MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE
- K921646 — NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON
- K915274 — METAL HALIDE LIGHT SOURCE MODEL LM 250
- K912252 — INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT
- K903800 — FIBER OPTIC LIGHT CABLE
- K901491 — CUDA SURGICAL LIGHT
- K901035 — FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE
- K893828 — ML-800 AUTOELECTRONIC LIGHT SOURCE
- K893491 — MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300
- K875004 — PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK
- K875005 — PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
- K875006 — PRISMA DISPOSA. BRITE LITE FIBEROPTIC ENDO. W/PICK
- K875007 — PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
- K875195 — OPHTHALMIC LIGHT PIPE PICK
- K870942 — MVS FIBEROPTIC LIGHTPIPE
- K864380 — LUTEX HEADLIGHT SYSTEMS
- K761142 — HEADLIGHTS W/ FILTER-OPTICO CABLES
Data sourced from openFDA. This site is unofficial and independent of the FDA.