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510(k) Data Aggregation

    K Number
    K241358
    Device Name
    BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E
    Manufacturer
    Sun Pharmaceutical Industries, Inc.
    Date Cleared
    2024-06-13

    (30 days)

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

    Sun Pharmaceutical Industries, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BLU-U® Blue Light Photodynamic Therapy Illuminator Model 4170E is intended to provide phototherapeutic light to the body. The BLU-U Model 4170E is generally indicated to treat dermatological indications. The BLU-U® Model 4170E is specifically indicated to treat moderate inflammatory acne vulgaris.
    Device Description
    Not Found
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