LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K072399
    Device Name
    DEL SOL RED LIGHT THERAPY SYSTEM
    Manufacturer
    EDGE SYSTEMS, INC.
    Date Cleared
    2008-05-23

    (270 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 Del Sol Red Light Therapy System is intended to emit energy in the near infrared spectrum (880nm) to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the document provided does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a red light therapy system, and it primarily focuses on the regulatory aspects of the device, such as its substantial equivalence to a predicate device and its intended use. It does not include details about device performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement as typically found in clinical study reports or detailed technical documentation.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1