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510(k) Data Aggregation

    K Number
    K091675
    Device Name
    LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER
    Manufacturer
    REIMERS AND JANSSEN GMBH
    Date Cleared
    2009-12-15

    (189 days)

    Product Code
    ILY
    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 RJ Low Level Laser are intended to emit energy in the infrared spectrum to provide topical heating for the purposes of elevating tissue temperature when heat is indicated for the temporary relief of minor muscle and joint pain and stiffness, for the temporary relief of minor joint pain associated with arthrilis, to temporarily increase local blood circulation where applied and the relaxation of muscles. This is a prescription only device.

    Device Description

    RJ Low Level Laser Family

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA. It does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, experts, adjudication), or MRMC comparative effectiveness studies for the "LaserPen® Expert" or related devices.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on FDA's determination of substantial equivalence to a predicate device and regulatory compliance.

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