LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K091158
    Device Name
    SCALAR WAVE LASER SYSTEM
    Manufacturer
    STELLAR LASERS
    Date Cleared
    2009-08-10

    (111 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 Scalar Wave Laser System is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Scalar Wave Laser System." It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The letter is primarily concerned with establishing "substantial equivalence" of the Scalar Wave Laser System to a predicate device, which is a regulatory pathway for certain medical devices. It confirms that the device can be marketed in the US, subject to general controls and FDA regulations.

    Therefore, I cannot provide the requested information based on the input text. The questions you've asked are typically addressed in a clinical study report or a 510(k) submission's performance data section, not in the FDA's clearance letter itself.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1