LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K142078
    Device Name
    VELASII THERAPY LASER SYSTEM
    Manufacturer
    ASPEN LASER SYSTEMS, LLC
    Date Cleared
    2014-10-30

    (91 days)

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

    VELASII THERAPY LASER SYSTEM

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

    The VelasII Therapy Laser System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for the VelasII Therapy Laser System. It does not contain any information about acceptance criteria or supporting studies that demonstrate the device meets these criteria.

    Therefore, I cannot provide the requested information. The document focuses on the regulatory approval process based on substantial equivalence to a predicate device, rather than detailed performance study results.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1