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510(k) Data Aggregation

    K Number
    K102083
    Device Name
    VELSCOPE VX
    Manufacturer
    LED DENTAL INC.
    Date Cleared
    2010-11-18

    (115 days)

    Product Code
    NXV
    Regulation Number
    872.6350
    Why did this record match?
    Applicant Name (Manufacturer) :

    LED DENTAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VELscope Vx is intended to be used by a dentist or health-care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer and premalignant dysplasia. VELscope Vx is further intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for surgical excision.
    Device Description
    The VELscope Vx system is a natural tissue fluorescence direct visualization system to be used as an adjunctive tool for oral mucosal examination. The main components of VELscope are the Handpiece, incorporating light source, viewing optics and rechargeable battery. Charging Cradle and external power supply. The VELscope Handpiece emits a safe, visible, blue light into the oral cavity, which excites the oral tissue and causes it to fluoresce. The oral cavity can then be examined in real time and suspicious tissue that may require further investigation can be quickly identified. When viewed through the VELscope Handpiece, abnormal tissue typically appears as an irregular, dark area that stands out against the otherwise normal green fluorescence pattern of surrounding health tissue.
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    K Number
    K070523
    Device Name
    MODIFICATION TO: VELSCOPE
    Manufacturer
    LED DENTAL INC.
    Date Cleared
    2007-04-05

    (41 days)

    Product Code
    NXV
    Regulation Number
    872.6350
    Why did this record match?
    Applicant Name (Manufacturer) :

    LED DENTAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VELscope is intended to be used by a dentist or health-care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or premalignant dysplasia. VELscope is further intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for surgical excision.
    Device Description
    VELscope is a natural tissue fluorescence direct visualization system to be used as an adjunctive tool for oral mucosal examination. The main components of VELscope are the Light Source Unit (LSU) and the viewing Handpiece. The VELscope Handpiece emits a safe, visible, blue light into the oral cavity, which excites the oral tissue and causes it to fluoresce. The oral cavity can then be examined in real time and suspicious tissue that may require further investigation can be quickly identified. When viewed through the VELscope Handpiece, healthy tissue typically shows up as a brighter green color while suspicious tissue can cause a loss of fluorescence, which thus appears dark.
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