LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K080513
    Device Name
    QLASER SYSTEM
    Manufacturer
    2035, INC.
    Date Cleared
    2009-01-30

    (340 days)

    Product Code
    NHN
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    2035, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The QLaser System is indicated for providing temporary relief of pain associated with osteoarthritis of the hand, which has been diagnosed by a physician or other licensed medical professional.
    Device Description
    Not Found
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1