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510(k) Data Aggregation

    K Number
    K070934
    Device Name
    PANOSOL II TRU-BLU, MODEL UBL-417
    Manufacturer
    NATIONAL BIOLOGICAL CORP.
    Date Cleared
    2007-05-22

    (49 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K100378
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Panosol II Tru-Blu UBL-417 is generally indicated to treat dermatological indications. The Panosol II Tru-Blu UBL-417 is specifically indicated to treat moderate inflammatory Acne Vulgaris

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, I cannot answer your request with the provided information. The text is a 510(k) clearance letter from the FDA for a phototherapy system. It confirms that the device is substantially equivalent to a predicate device and can be marketed. It does not contain any details about acceptance criteria or a study proving the device meets those criteria, as it is a regulatory document and not a clinical study report.

    Therefore, I cannot provide:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes, data provenance, number of experts, qualifications of experts, adjudication methods for a test set.
    3. Information about MRMC comparative effectiveness studies or standalone algorithm performance.
    4. Details about the type of ground truth used or the training set size and ground truth establishment.
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