FST · Class II · 21 CFR 878.4580

FDA Product Code FST: Light, Surgical, Fiberoptic

Leading manufacturers include Advanced Surgical Products, Inc., Cuda Products Co. and Medical Illumination International, Inc..

45
Total
45
Cleared
79d
Avg days
1977
Since
45 devices
25–45 of 45
Cleared Jan 31, 1996
X6000D SILENT SUN LIGHT SOURCE
K955510
Products For Medicine
General & Plastic Surgery · 58d
Cleared Mar 10, 1994
LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND)
K936048
Cogent Light Technologies, Inc.
General & Plastic Surgery · 80d
Cleared Feb 09, 1994
END-IRRIGATING ENDOILLUMINATOR
K931546
Infinitech, Inc.
General & Plastic Surgery · 317d
Cleared Sep 02, 1992
WOODBINE XT350, XENON ARC LIGHT SOURCE
K922820
Woodbine Ptical Corp.
General & Plastic Surgery · 83d
Cleared Aug 07, 1992
MEDICAM 900 AUTOELECTRONIC LIGHT SOURCE
K922544
Kirschner Medical Corp.
General & Plastic Surgery · 70d
Cleared May 13, 1992
NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON
K921646
Nextec Corp.
General & Plastic Surgery · 37d
Cleared Jan 23, 1992
METAL HALIDE LIGHT SOURCE MODEL LM 250
K915274
Pentax Precision Instrument Corp.
General & Plastic Surgery · 59d
Cleared Jun 27, 1991
INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT
K912252
Fiberoptic Medical Products, Inc.
General & Plastic Surgery · 37d
Cleared Aug 29, 1990
FIBER OPTIC LIGHT CABLE
K903800
Orlux Engineering and Instrumentation
General & Plastic Surgery · 9d
Cleared Jun 18, 1990
CUDA SURGICAL LIGHT
K901491
Cuda Products Co.
General & Plastic Surgery · 81d
Cleared Apr 23, 1990
FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE
K901035
Cuda Products Co.
General & Plastic Surgery · 48d
Cleared Jul 24, 1989
ML-800 AUTOELECTRONIC LIGHT SOURCE
K893828
M.P. Video, Inc.
General & Plastic Surgery · 61d
Cleared Jun 22, 1989
MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300
K893491
Cuda Products Co.
General & Plastic Surgery · 49d
Cleared Mar 14, 1988
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDO. W/PICK
K875004
Advanced Surgical Products, Inc.
General & Plastic Surgery · 101d
Cleared Mar 14, 1988
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
K875005
Advanced Surgical Products, Inc.
General & Plastic Surgery · 101d
Cleared Mar 14, 1988
PRISMA DISPOSA. BRITE LITE FIBEROPTIC ENDO. W/PICK
K875006
Advanced Surgical Products, Inc.
General & Plastic Surgery · 101d
Cleared Mar 14, 1988
PRISMA DISPOS. BRITE LITE FIBEROPTIC ENDOILLUMINA.
K875007
Advanced Surgical Products, Inc.
General & Plastic Surgery · 101d
Cleared Mar 07, 1988
OPHTHALMIC LIGHT PIPE PICK
K875195
Trek Medical Products, Inc.
General & Plastic Surgery · 81d
Cleared Apr 03, 1987
MVS FIBEROPTIC LIGHTPIPE
K870942
Advanced Surgical Products, Inc.
General & Plastic Surgery · 25d
Cleared Nov 19, 1986
LUTEX HEADLIGHT SYSTEMS
K864380
Luxtec Corp.
General & Plastic Surgery · 14d
Cleared Jan 05, 1977
HEADLIGHTS W/ FILTER-OPTICO CABLES
K761142
Pilling Co.
General & Plastic Surgery · 40d