FDA Product Code
FDA Product Code FST — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4580
510(k) Clearances — 45 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K200874 | TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End | Innovasis, Inc. | 2020-06-30 | Traditional | PDF ↗ |
| K141330 | ENDO-CORD | Enroxtech, Inc. | 2014-12-15 | Traditional | PDF ↗ |
| K122637 | LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999 | Stryker Spine | 2012-11-01 | Traditional | PDF ↗ |
| K113697 | EIGR SURGICAL ILLUMINATION SYSTEM | Invuity, Inc. | 2012-02-10 | Special | PDF ↗ |
| K113330 | CABLECAP | Sensormed | 2012-01-12 | Traditional | PDF ↗ |
| K102266 | ISOLED AC-POWERED LED HEADLIGHT SYSTEM | Isolux, LLC | 2010-09-24 | Traditional | PDF ↗ |
| K101496 | CABLECAP MODEL: WLF, STZ, ACM | Sensormed | 2010-09-14 | Traditional | PDF ↗ |
| K100388 | 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS | Medical Illumination International, Inc. | 2010-06-22 | Traditional | PDF ↗ |
| K100395 | HARMONY VLED SURGICAL LIGHTNING SYSTEM | STERIS Corporation | 2010-03-17 | Special | PDF ↗ |
| K093386 | CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST | Bfw, Inc. | 2010-01-28 | Traditional | PDF ↗ |
| K090070 | INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM | Invuity, Inc. | 2009-04-22 | Traditional | PDF ↗ |
| K083710 | RETRACTOR LITE | Thomas Surgical Instruments, Inc. | 2009-02-23 | Traditional | PDF ↗ |
| K082992 | AXXION LIGHT GUIDE | Spinal Elements, Inc. | 2009-02-18 | Traditional | PDF ↗ |
| K080962 | LITE WAND II | Thompson Surgical Instruments, Inc. | 2008-06-25 | Traditional | PDF ↗ |
| K080367 | ZIMMER MIS LIGHT | Zimmer Spine, Inc. | 2008-02-22 | Traditional | PDF ↗ |
| K071218 | PROXENON 350, MODEL 902XX | Welch Allyn, Inc. | 2007-06-14 | Traditional | PDF ↗ |
| K061690 | SURGICAL HEADLIGHT | Gulf Medical Fiberoptics | 2006-09-15 | Traditional | PDF ↗ |
| K053227 | LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES | Medical Illumination International, Inc. | 2006-01-13 | Traditional | PDF ↗ |
| K051786 | MELIDE FIBEROPTIC LIGHT | Designs For Vision, Inc. | 2005-08-15 | Special | PDF ↗ |
| K042034 | NUVASIVE MAXCESS LIGHT GUIDE | Nuvasive, Inc. | 2004-10-26 | Traditional | PDF ↗ |
| K003577 | STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT | STERIS Corporation | 2001-01-29 | Abbreviated | PDF ↗ |
| K000728 | MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE | Medtronic Xomed | 2000-03-21 | Traditional | PDF ↗ |
| K991572 | ISOLUX SURGICAL HEADLIGHT | Isolux America | 1999-07-08 | Traditional | PDF ↗ |
| K972225 | UFR FIBEROPTIC CABLE | Universal Fiberoptic Repair, Inc. | 1998-03-18 | Traditional | PDF ↗ |
| K955510 | X6000D SILENT SUN LIGHT SOURCE | Products For Medicine | 1996-01-31 | Traditional | PDF ↗ |
| K936048 | LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND) | Cogent Light Technologies, Inc. | 1994-03-10 | Traditional | PDF ↗ |
| K931546 | END-IRRIGATING ENDOILLUMINATOR | Infinitech, Inc. | 1994-02-09 | Traditional | PDF ↗ |
| K922820 | WOODBINE XT350, XENON ARC LIGHT SOURCE | Woodbine Ptical Corp. | 1992-09-02 | Traditional | PDF ↗ |
| K922544 | MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE | Kirschner Medical Corp. | 1992-08-07 | Traditional | PDF ↗ |
| K921646 | NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON | Nextec Corp. | 1992-05-13 | Traditional | PDF ↗ |
| K915274 | METAL HALIDE LIGHT SOURCE MODEL LM 250 | Pentax Precision Instrument Corp. | 1992-01-23 | Traditional | PDF ↗ |
| K912252 | INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT | Fiberoptic Medical Products, Inc. | 1991-06-27 | Traditional | PDF ↗ |
| K903800 | FIBER OPTIC LIGHT CABLE | Orlux Engineering and Instrumentation | 1990-08-29 | Traditional | PDF ↗ |
| K901491 | CUDA SURGICAL LIGHT | Cuda Products Co. | 1990-06-18 | Traditional | PDF ↗ |
| K901035 | FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE | Cuda Products Co. | 1990-04-23 | Traditional | PDF ↗ |
| K893828 | ML-800 AUTOELECTRONIC LIGHT SOURCE | M.P. Video, Inc. | 1989-07-24 | Traditional | PDF ↗ |
| K893491 | MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300 | Cuda Products Co. | 1989-06-22 | Traditional | PDF ↗ |
| K875006 | PRISMA DISPOSA. BRITE LITE FIBEROPTIC ENDO. W/PICK | Advanced Surgical Products, Inc. | 1988-03-14 | Traditional | PDF ↗ |
| K875005 | PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA. | Advanced Surgical Products, Inc. | 1988-03-14 | Traditional | PDF ↗ |
| K875004 | PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK | Advanced Surgical Products, Inc. | 1988-03-14 | Traditional | PDF ↗ |
| K875007 | PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA. | Advanced Surgical Products, Inc. | 1988-03-14 | Traditional | PDF ↗ |
| K875195 | OPHTHALMIC LIGHT PIPE PICK | Trek Medical Products, Inc. | 1988-03-07 | Traditional | PDF ↗ |
| K870942 | MVS FIBEROPTIC LIGHTPIPE | Advanced Surgical Products, Inc. | 1987-04-03 | Traditional | PDF ↗ |
| K864380 | LUTEX HEADLIGHT SYSTEMS | Luxtec Corp. | 1986-11-19 | Traditional | PDF ↗ |
| K761142 | HEADLIGHTS W/ FILTER-OPTICO CABLES | Pilling Co. | 1977-01-05 | Traditional | PDF ↗ |
Product code FST · Class II · General, Plastic Surgery. Data: openFDA.