Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K080689
    Device Name
    SPECTRA THERAPY SYSTEM A1000 LASER DEVICE
    Date Cleared
    2008-07-09

    (120 days)

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

    PREMIER DYNAMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Spectra Therapy Spectra A1000 is an infrared lamp intended to provide topical heating. The Spectra Therapy Spectra A1000 is indicated for the 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
    The Spectra Therapy Spectra A1000 is an infrared lamp intended to provide topical heating. The Spectra A1000 is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle pain and/or the temporary relaxation of muscle. The Spectra A1000 System houses multiple photo energy devices. The photo devices consist of 4 dual [infrared and RED visible] lasers combined with a cluster of 8 visible RED LED's, and 8 Infrared LED's and a yellow indicator lamp. The Spectra A1000 Laser Therapy Device consists of a docking unit, a USB and laser port, a key port and a key. The laser and light therapy releases radiation with wing wavelengths, all of which fall within the infrared range as defined in 21 CFR 890.5500.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1