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510(k) Data Aggregation

    K Number
    K222109
    Device Name
    Accure Laser
    Manufacturer
    Date Cleared
    2022-11-17

    (122 days)

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

    Accure Acne, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Accure Laser System is indicated for the treatment of mild to severe inflammatory acne vulgaris.
    Device Description
    Not Found
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