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510(k) Data Aggregation
K Number
K032283Device Name
DESIGNS FOR VISION FIBEROPTIC LIGHT
Manufacturer
DESIGNS FOR VISION, INC.
Date Cleared
2003-08-20
(27 days)
Product Code
GDB
Regulation Number
876.1500Why did this record match?
Product Code :
GDB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Designs for Vision Fiberoptic Light is indicated for use in surgery and medical applications where high intensity illumination is required.
Device Description
The Designs for Vision Fiberoptic Light is composed of a high intensity light source, fiberoptic cables, and fiberoptic headsets. The Designs for Vision headsets have been marketed since the early 1970s with a long history of safe use in the surgical suite. The headsets are coaxial, bifurcated, or focusable designs.
The light source includes a chuck for fiberoptic cable attachment. The Light source provides a 150-watt power output and contains a continuous illumination level adjustment, which provides 3200 K color temperature light.
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K Number
K961536Device Name
FLEXSCOPE
Manufacturer
MATRIX MEDICA, INC.
Date Cleared
1996-09-18
(149 days)
Product Code
GDB
Regulation Number
876.1500Why did this record match?
Product Code :
GDB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FlexScope is intended to be used for visualization of tissue in The general surgical applications.
Device Description
The FlexScope™ is a flexible deflectable endoscope intended to allow physicians to visualize tissue in body cavities and through natural body orifices. The device is designed to be advanced to the site of interest through a cannula or trocar or may be used in an open procedure. The device will is available in various diameters.
The method of construction and materials used for these flexible fiber optic endoscopes are substantially equivalent to previous endoscope products.
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