Atlas FDA

FST

45 FDA 510(k) clearances · Product code

70 daysmedian time to decision
126 days90th percentile
45clearances measured

FDA profile

Official device name
Light, Surgical, Fiberoptic
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Medical specialty
General, Plastic Surgery
Flags
Third-party review eligible
Adverse events (MAUDE)
2018: 12 · 2019: 29 · 2020: 33 · 2021: 20 · 2024: 40 · 2025: 28
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End (K200874)Innovasis, Inc.2020-06-30
ENDO-CORD (K141330)Enroxtech, Inc.2014-12-15
LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999 (K122637)Stryker Spine2012-11-01
EIGR SURGICAL ILLUMINATION SYSTEM (K113697)Invuity, Inc.2012-02-10
CABLECAP (K113330)Sensormed2012-01-12
ISOLED AC-POWERED LED HEADLIGHT SYSTEM (K102266)Isolux, LLC2010-09-24
CABLECAP MODEL: WLF, STZ, ACM (K101496)Sensormed2010-09-14
21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS (K100388)Medical Illumination International, Inc.2010-06-22
HARMONY VLED SURGICAL LIGHTNING SYSTEM (K100395)STERIS Corporation2010-03-17
CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST (K093386)Bfw, Inc.2010-01-28
INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM (K090070)Invuity, Inc.2009-04-22
RETRACTOR LITE (K083710)Thomas Surgical Instruments, Inc.2009-02-23
AXXION LIGHT GUIDE (K082992)Spinal Elements, Inc.2009-02-18
LITE WAND II (K080962)Thompson Surgical Instruments, Inc.2008-06-25
ZIMMER MIS LIGHT (K080367)Zimmer Spine, Inc.2008-02-22
PROXENON 350, MODEL 902XX (K071218)Welch Allyn, Inc.2007-06-14
SURGICAL HEADLIGHT (K061690)Gulf Medical Fiberoptics2006-09-15
LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES (K053227)Medical Illumination International, Inc.2006-01-13
MELIDE FIBEROPTIC LIGHT (K051786)Designs For Vision, Inc.2005-08-15
NUVASIVE MAXCESS LIGHT GUIDE (K042034)Nuvasive, Inc.2004-10-26
STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT (K003577)STERIS Corporation2001-01-29
MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE (K000728)Medtronic Xomed2000-03-21
ISOLUX SURGICAL HEADLIGHT (K991572)Isolux America1999-07-08
UFR FIBEROPTIC CABLE (K972225)Universal Fiberoptic Repair, Inc.1998-03-18
X6000D SILENT SUN LIGHT SOURCE (K955510)Products For Medicine1996-01-31
LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND) (K936048)Cogent Light Technologies, Inc.1994-03-10
END-IRRIGATING ENDOILLUMINATOR (K931546)Infinitech, Inc.1994-02-09
WOODBINE XT350, XENON ARC LIGHT SOURCE (K922820)Woodbine Ptical Corp.1992-09-02
MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE (K922544)Kirschner Medical Corp.1992-08-07
NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON (K921646)Nextec Corp.1992-05-13
METAL HALIDE LIGHT SOURCE MODEL LM 250 (K915274)Pentax Precision Instrument Corp.1992-01-23
INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT (K912252)Fiberoptic Medical Products, Inc.1991-06-27
FIBER OPTIC LIGHT CABLE (K903800)Orlux Engineering and Instrumentation1990-08-29
CUDA SURGICAL LIGHT (K901491)Cuda Products Co.1990-06-18
FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE (K901035)Cuda Products Co.1990-04-23
ML-800 AUTOELECTRONIC LIGHT SOURCE (K893828)M.P. Video, Inc.1989-07-24
MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300 (K893491)Cuda Products Co.1989-06-22
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK (K875004)Advanced Surgical Products, Inc.1988-03-14
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA. (K875007)Advanced Surgical Products, Inc.1988-03-14
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA. (K875005)Advanced Surgical Products, Inc.1988-03-14
PRISMA DISPOSA. BRITE LITE FIBEROPTIC ENDO. W/PICK (K875006)Advanced Surgical Products, Inc.1988-03-14
OPHTHALMIC LIGHT PIPE PICK (K875195)Trek Medical Products, Inc.1988-03-07
MVS FIBEROPTIC LIGHTPIPE (K870942)Advanced Surgical Products, Inc.1987-04-03
LUTEX HEADLIGHT SYSTEMS (K864380)Luxtec Corp.1986-11-19
HEADLIGHTS W/ FILTER-OPTICO CABLES (K761142)Pilling Co.1977-01-05

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