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510(k) Data Aggregation

    K Number
    K061656
    Device Name
    LASER-D68
    Manufacturer
    LASER PAIN CLINICS LP
    Date Cleared
    2006-12-15

    (189 days)

    Product Code
    GEX, ILY
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    LASER PAIN CLINICS LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Laser-D68 System provides visible red and infrared therapy to provide topical heating for the temporary: - Increase in local blood circulation - Relief of minor muscles and joint aches, pains and stiffness . - Relaxation of muscles . - . Relief of muscle spasms - . Relief of minor pain and stiffness associated with arthritis
    Device Description
    The Laser-D68 is a non-invasive, low energy infrared therapeutic medical laser that is intended to perform laser therapy in healthcare centers, physical therapy laboratories, and family doctor practices. The Laser D68 is supplied with three different probes that are used to generate, laser radiation when connected to the D68 driver unit. Probe #1 is a 660nm, Indium Gallium Aluminum Phoshpide (InGaAIP) laser diode (visible red light) with an adjustable treatment power output from 1 milliwatts (mW) to 50 milliwatts (mW) (in 1mW increments). Probe #2 is an 830nm, Gallium Aluminum Arsenide (GaAIAs) Iaser diode (infrared light) with an adjustable treatment power output from 20 milliwatts to 400 milliwatts (in 5mW increments). Probe #3 is a 904nm, Gallium Arsenide (GaAs) laser diode (infrared light) with adjustable treatment power output of either SmW to 90mW (in 5mW increments) (45W laser power source) or 5 mW to 150mW (in 5 mW increment) (75W modulated laser power source). Each of the laser probes are fully interchangeable with the D68 driver.
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