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510(k) Data Aggregation

    K Number
    K051548

    Validate with FDA (Live)

    Device Name
    IRRADIA MID - LASER (S3)
    Manufacturer
    IRRADIA AB
    Date Cleared
    2005-10-24

    (133 days)

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

    Provide topical heating for the purpose of elevating tissue temperature for the relief of muscle and joint pain and stiffness, minor arthritis pain and muscle spasm

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the given text.

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