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510(k) Data Aggregation

    K Number
    K100116
    Device Name
    LASERTOUCHONE (OTC)
    Date Cleared
    2010-04-15

    (90 days)

    Product Code
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    LASER HEALTH TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LaserTouchOne™(OTC) is a low level laser and electrical stimulation device. This combination of low level light and electrical stimulation provides symptomatic relief of chronic, intractable pain, and is indicated for adjunctive treatment of post-surgical and post-traumatic acute pain and for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
    Device Description
    The LaserTouchOne™ (LTO) device is a rechargeable hand-held pain therapy device. It combines the technology of low level laser and transcutaneous electrical nerve stimulation in one unit. The low level (cold) laser therapy (LLLT) is delivered with a single diode laser of <1 mW, 670 nm. The pulsed electrical stimulation is simultaneously delivered though stainless steel contact points, using an electroconductive gel as the contact medium.
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    K Number
    K083822
    Device Name
    LASER TOUCHONE
    Date Cleared
    2009-05-06

    (135 days)

    Product Code
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    LASER HEALTH TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LaserTouchOne™ is a low level laser and electrical stimulation device. This combination of low level light and electrical stimulation provides symptomatic relief of chronic, intractable pain, and is indicated for adjunctive treatment of postsurgical and post-traumatic acute pain and for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
    Device Description
    The LaserTouchOne™ device is a rechargeable hand-held pain therapy device. It combines the technology of low level laser and transcutaneous electrical nerve stimulation in one unit. The low level (cold) laser therapy is delivered with a single diode laser of <1 mW, 670 nm, and the pulsed electrical stimulation is of low magnitude. The device is provided with a power recharging unit and a tube of electroconductive gel.
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