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510(k) Data Aggregation

    K Number
    K073503
    Device Name
    VERSA LITE
    Manufacturer
    DIOMEDICS, INC.
    Date Cleared
    2008-01-23

    (41 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIOMEDICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K982546
    Device Name
    PHASER-2000
    Manufacturer
    DIOMEDICS, INC.
    Date Cleared
    1998-09-22

    (63 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIOMEDICS, INC.

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

    The PAIN-X-2000 is indicated for use to emit energy in the Infrared Spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device named PAIN-X-2000. It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this letter does not contain any information regarding specific acceptance criteria, device performance metrics, or study details such as sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information about sample sizes, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, or training set specifics based on this document.

    The document only states the device's indications for use: "to emit energy in the Infrared Spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature." It then confirms its regulatory classification and allows it to be marketed.

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