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510(k) Data Aggregation

    K Number
    K060920
    Device Name
    VELSCOPE
    Manufacturer
    LED MEDICAL DIAGNOSTICS INC.
    Date Cleared
    2006-04-27

    (23 days)

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

    LED MEDICAL DIAGNOSTICS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VELscope is to be used by qualified health-care providers to enhance the identification and visualization of oral mucosal abnormalities by exciting the tissue with blue light and allowing the direct visualization of the resulting natural tissue fluorescence. VELscope is complimentary to and is intended to be used in combination with a traditional oral mucosal examination with white light. VELscope is intended to be used by a dentist or heatth-care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities.
    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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