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510(k) Data Aggregation

    K Number
    K150986
    Device Name
    Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants
    Manufacturer
    MEDDEV CORPORATION
    Date Cleared
    2015-08-17

    (125 days)

    Product Code
    MML
    Regulation Number
    886.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDDEV CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MedDev Contour™ and ThinProfile™ Eyelid Weight Implants are designed for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.
    Device Description
    MedDev Contour™ and ThinProfile™ Eyelid Weight Implants were designed for the treatment of lagophthalmos, i.e. the inability of the eyelid to fully close. This condition is typically due to a degree of facial paralysis. The MedDev Contour™ and ThinProfile™ Eyelid Weight Implants are passive implants surgically placed in the eyelid. The density of their construct material (pure gold or platinum) provides the weight necessary to close the eyelid over the eye. The patient can use their functional orbital musculature to keep their eyes open, but have the gravitational assist from the Implant to close the eyelid.
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