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510(k) Data Aggregation

    K Number
    K051786
    Device Name
    MELIDE FIBEROPTIC LIGHT
    Manufacturer
    DESIGNS FOR VISION, INC.
    Date Cleared
    2005-08-15

    (45 days)

    Product Code
    FST
    Regulation Number
    878.4580
    Why 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
    K043530
    Device Name
    DVI CURING LIGHT
    Manufacturer
    DESIGNS FOR VISION, INC.
    Date Cleared
    2005-01-25

    (35 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why 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
    K032283
    Device Name
    DESIGNS FOR VISION FIBEROPTIC LIGHT
    Manufacturer
    DESIGNS FOR VISION, INC.
    Date Cleared
    2003-08-20

    (27 days)

    Product Code
    GDB
    Regulation Number
    876.1500
    Why 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
    K013880
    Device Name
    DAYLITE XENON LIGHT SOURCES
    Manufacturer
    DESIGNS FOR VISION, INC.
    Date Cleared
    2001-12-07

    (14 days)

    Product Code
    GCT
    Regulation Number
    876.1500
    Why 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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