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510(k) Data Aggregation

    K Number
    K101430
    Device Name
    MLS-AC DERMA SCANNER
    Manufacturer
    ERCHONIA CORPORATION
    Date Cleared
    2010-06-22

    (32 days)

    Product Code
    NHN
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MLS-AC Derma Scanner™ is indicated while using the red diodes for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin, and while using the blue diode, to treat moderate inflammatory Acne Vulgaris.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the MLS-AC Derma Scanner™, and it does not contain information about acceptance criteria or a study proving the device meets those criteria.

    The letter from the FDA states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance. This substantial equivalence is typically established by demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or if there are differences, that those differences do not raise new questions of safety or effectiveness.

    Therefore, I cannot extract the requested information from this document. To answer your questions, one would need access to the actual 510(k) submission and the studies referenced within it, which are not included in the provided text.

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