Light, Surgical, Fiberoptic

FDA product code FST · 44 cleared devices

Class 2 General, Plastic Surgery

Regulation: 21 CFR 878.4580
Review panel: SU
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-01-05 – 2020-06-30

FST 2020-06-30

TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End

Applicant Innovasis, Inc.

K number K200874

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FST 2012-11-01

LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999

Applicant Stryker Spine

K number K122637

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FST 2012-02-10

EIGR SURGICAL ILLUMINATION SYSTEM

Applicant Invuity, Inc.

K number K113697

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FST 2012-01-12

CABLECAP

Applicant Sensormed

K number K113330

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FST 2010-09-24

ISOLED AC-POWERED LED HEADLIGHT SYSTEM

Applicant Isolux, LLC

K number K102266

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FST 2010-09-14

CABLECAP MODEL: WLF, STZ, ACM

Applicant Sensormed

K number K101496

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FST 2010-06-22

21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS

Applicant Medical Illumination International, Inc.

K number K100388

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FST 2010-03-17

HARMONY VLED SURGICAL LIGHTNING SYSTEM

Applicant STERIS Corporation

K number K100395

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FST 2010-01-28

CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST

Applicant Bfw, Inc.

K number K093386

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FST 2009-04-22

INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM

Applicant Invuity, Inc.

K number K090070

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FST 2009-02-23

RETRACTOR LITE

Applicant Thomas Surgical Instruments, Inc.

K number K083710

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FST 2009-02-18

AXXION LIGHT GUIDE

Applicant Spinal Elements, Inc.

K number K082992

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FST 2008-06-25

LITE WAND II

Applicant Thompson Surgical Instruments, Inc.

K number K080962

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FST 2008-02-22

ZIMMER MIS LIGHT

Applicant Zimmer Spine, Inc.

K number K080367

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FST 2007-06-14

PROXENON 350, MODEL 902XX

Applicant Welch Allyn, Inc.

K number K071218

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FST 2006-09-15

SURGICAL HEADLIGHT

Applicant Gulf Medical Fiberoptics

K number K061690

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FST 2006-01-13

LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES

Applicant Medical Illumination International, Inc.

K number K053227

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FST 2005-08-15

MELIDE FIBEROPTIC LIGHT

Applicant Designs For Vision, Inc.

K number K051786

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FST 2004-10-26

NUVASIVE MAXCESS LIGHT GUIDE

Applicant Nuvasive, Inc.

K number K042034

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FST 2001-01-29

STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT

Applicant STERIS Corporation

K number K003577

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FST 2000-03-21

MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE

Applicant Medtronic Xomed

K number K000728

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FST 1999-07-08

ISOLUX SURGICAL HEADLIGHT

Applicant Isolux America

K number K991572

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FST 1998-03-18

UFR FIBEROPTIC CABLE

Applicant Universal Fiberoptic Repair, Inc.

K number K972225

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FST 1996-01-31

X6000D SILENT SUN LIGHT SOURCE

Applicant Products For Medicine

K number K955510

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FST 1994-03-10

LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND)

Applicant Cogent Light Technologies, Inc.

K number K936048

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FST 1994-02-09

END-IRRIGATING ENDOILLUMINATOR

Applicant Infinitech, Inc.

K number K931546

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FST 1992-09-02

WOODBINE XT350, XENON ARC LIGHT SOURCE

Applicant Woodbine Ptical Corp.

K number K922820

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FST 1992-08-07

MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE

Applicant Kirschner Medical Corp.

K number K922544

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FST 1992-05-13

NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON

Applicant Nextec Corp.

K number K921646

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FST 1992-01-23

METAL HALIDE LIGHT SOURCE MODEL LM 250

Applicant Pentax Precision Instrument Corp.

K number K915274

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FST 1991-06-27

INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT

Applicant Fiberoptic Medical Products, Inc.

K number K912252

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FST 1990-08-29

FIBER OPTIC LIGHT CABLE

Applicant Orlux Engineering and Instrumentation

K number K903800

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FST 1990-06-18

CUDA SURGICAL LIGHT

Applicant Cuda Products Co.

K number K901491

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FST 1990-04-23

FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE

Applicant Cuda Products Co.

K number K901035

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FST 1989-07-24

ML-800 AUTOELECTRONIC LIGHT SOURCE

Applicant M.P. Video, Inc.

K number K893828

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FST 1989-06-22

MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300

Applicant Cuda Products Co.

K number K893491

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FST 1988-03-14

PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.

Applicant Advanced Surgical Products, Inc.

K number K875007

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FST 1988-03-14

PRISMA DISPOSA. BRITE LITE FIBEROPTIC ENDO. W/PICK

Applicant Advanced Surgical Products, Inc.

K number K875006

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FST 1988-03-14

PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.

Applicant Advanced Surgical Products, Inc.

K number K875005

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FST 1988-03-14

PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK

Applicant Advanced Surgical Products, Inc.

K number K875004

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FST 1988-03-07

OPHTHALMIC LIGHT PIPE PICK

Applicant Trek Medical Products, Inc.

K number K875195

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FST 1987-04-03

MVS FIBEROPTIC LIGHTPIPE

Applicant Advanced Surgical Products, Inc.

K number K870942

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FST 1986-11-19

LUTEX HEADLIGHT SYSTEMS

Applicant Luxtec Corp.

K number K864380

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FST 1977-01-05

HEADLIGHTS W/ FILTER-OPTICO CABLES

Applicant Pilling Co.

K number K761142

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