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510(k) Data Aggregation

    K Number
    K040662
    Device Name
    VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) LASER SYSTEMS
    Manufacturer
    CHATTANOOGA GROUP
    Date Cleared
    2004-09-08

    (180 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K951167,K971033,K003716,K050186,K100224
    Predicate For
    K050070,K052647,K053473,K070516,K073352,K081962,K082969,K132284,K141564,K150353
    Why did this record match?
    Reference Devices :

    K951167, K971033, K003716, K050186, K100224

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

    For Infrared Lamp (Laser)

    Vectra Genisys (Intelect XT) Laser Module and Vectra Genisys (Intelect XT) Laser Transportable Systems are indicated for topical heating for:

    • temporary increase in local blood circulation
    • temporary relief of minor muscle and joint aches, pains and stiffness
    • relaxation of muscles
    • temporary relief of muscle spasms
    • temporary relief of minor pain and stiffness associated with arthritis
    Device Description

    Vectra Genisys Laser System (Intelect XT Laser System)

    AI/ML Overview

    I am sorry, but based on the provided documents, I cannot answer your request. The documents are a 510(k) clearance letter from the FDA for a medical device (Vectra Genisys Laser System) and its indications for use. They do not contain information about acceptance criteria, study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), multi-reader multi-case studies, or standalone algorithm performance.

    These documents primarily confirm that the device is substantially equivalent to a legally marketed predicate device and outline its approved indications for use. They do not describe the specific testing and validation studies typically required to demonstrate performance against acceptance criteria in the way your request specifies.

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