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510(k) Data Aggregation

    K Number
    K070296
    Device Name
    VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM
    Manufacturer
    ACE VISION GROUP
    Date Cleared
    2007-10-03

    (245 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACE VISION GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VisioLite® is indicated for the ophthalmic soft tissue surrounding the eye and orbit.
    Device Description
    The VisioLite® Ophthalmic Er: Y AG Laser System creates a laser beam with a wavelength of 2940nm, which is highly absorbed by water, collagen and hydroxy apatite and therefore causes rapid vaporization, or ablation, in both hard and soft biological tissues. Because the absorption is highly efficient, tissue removal is very precise with virtually no collateral thermal damage.
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