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510(k) Data Aggregation
K Number
K051786Device Name
MELIDE FIBEROPTIC LIGHT
Manufacturer
DESIGNS FOR VISION, INC.
Date Cleared
2005-08-15
(45 days)
Product Code
FST
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
DESIGNS FOR VISION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Designs for Vision Melide Fiberoptic Light is indicated for use in surgery and medical applications where high intensity illumination is required.
Device Description
The Designs for Vision Melide Fiberoptic Light (Melide Fiberoptic Light) is a modification of other legally marketed Designs for Vision surgical headlight systems. The Melide Fiberoptic Light consists of a lamp mounted in a chassis that also holds the AC power supply, dimmer for light intensity control, and a 530 nm filter. Light is passed through a fiberoptic cable to a set of optics in the headlight. The Melide Fiberoptic Light is compatible with all of the headsets available for use with the Designs for Vision surgical headlight systems described in K032283.
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K Number
K043530Device Name
DVI CURING LIGHT
Manufacturer
DESIGNS FOR VISION, INC.
Date Cleared
2005-01-25
(35 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
DESIGNS FOR VISION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DVI Curing Light is a dental curing light that is intended for the photopolymerization of dental resins.
Device Description
The DVI Curing Light consists of three major components; a handpiece, curved fiber optic end tip, and cradle. The handpiece contains the LED light source and a fiber optic light guide that directs light to the treatment area on the patient. The handpiece is placed in a cradle, which is connected via a plug-in transformer to an AC outlet for charging. A Protective light-shield and Fiber-optic end-tips are accessories provided with the DVI Curing Light, which support the operation and maintenance of the device.
The DVI curing light initiates curing (polymerization) of materials that are activated by photo initiators with an absorption in the wavelength range of between 405 to 470 nm. It is recommended that materials manufacturer's directions be followed for curing times. It is recommended that curing times be extended when curing through the tooth structure or when the distance from the curing light end tip to the material exceeds 3 mm.
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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?
Applicant Name (Manufacturer) :
DESIGNS FOR VISION, INC.
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
K013880Device Name
DAYLITE XENON LIGHT SOURCES
Manufacturer
DESIGNS FOR VISION, INC.
Date Cleared
2001-12-07
(14 days)
Product Code
GCT
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
DESIGNS FOR VISION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Daylite Xenon Light Source is indicated for use in surgery and medical applications where high intensity illumination is required
Device Description
The Daylite XeNon Light Sources are comprised of high intensity xenon light sources, fiberoptic cables and fiberoptic headsets. The Designs for Vision Daylite Light Sources are supplied with headsets that were first placed into service prior to 1976 and are preamendment devices. The Designs for Vision headsets have been marketed since the early 1970's with a long history of safe use in the surgical suite. The headsets are either coaxial, bifurcated, or focusable designs. The light source includes a universal chuck for fiberoptic cable attachment. The universal chuck accepts various sizes of light cables. The XeNon Light sources provide either 180-watt or 300-watt power output and contain a continuous illumination level adjustment which provides 6000°K color temperature light.
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