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510(k) Data Aggregation

    K Number
    K033015
    Device Name
    AXIOM BIOLASER LLLT SERIES-3
    Manufacturer
    AXIOM USA. INC
    Date Cleared
    2003-11-25

    (60 days)

    Product Code
    NHN
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K030692,K010175
    Why did this record match?
    Device Name :

    AXIOM BIOLASER LLLT SERIES-3

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Axiom BioLaser LLLT Series-3 is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.

    Device Description

    The Axiom Bio LLLT Series -3 is a non thermal triple diode infrared laser.

    AI/ML Overview

    There is no information in the provided text regarding acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) summary and the FDA's clearance letter for the Axiom BioLaser LLT Series-3, which establishes its substantial equivalence to predicate devices for its intended use in temporarily relieving hand and wrist pain associated with Carpal Tunnel Syndrome.

    Therefore, I cannot provide the requested information in the table or answer the specific questions about the study design, sample sizes, ground truth establishment, or multi-reader studies.

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