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510(k) Data Aggregation

    K Number
    K082586
    Device Name
    LIGHTWAVE PROFESSIONAL DELUXE
    Manufacturer
    LIGHTWAVE TECHNOLOGIES LLC
    Date Cleared
    2010-01-04

    (483 days)

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

    LIGHTWAVE TECHNOLOGIES LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LIGHTWAVE Deluxe Red light is indicated for use in dermatology for treatment of superficial; benign vascular, and pigmented lesions. The LIGHTWAVE Deluxe Red and Blue light combination is intended to emit energy in the red and blue region of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris. THE LIGHTWAVE Deluxe Blue light is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. THE LIGHTWAVE Deluxe Red and Blue light combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. THE LIGHTWAVE Deluxe Infrared Light is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
    Device Description
    The LIGHTWAVE™ Professional Deluxe System uses high-end Light Emitting Diodes (LED's) to distribute the specific wavelengths of light it uses. This technology is commonly referred to as Photobiostimulation, Light Emitting Diode Therapy (LEDT), LLLT, or LED's. The application of LED's to tissue is non-invasive. These devices are solid state and hand free mounted for placement directly over the skin where the treatment is to occur. The LIGHTWAVE Professional Deluxe LED system is a combination of two sources of high chromatic accuracy. They provide uniform even coverage exposure area. The output wavelengths of LIGHTWAVE Professional Deluxe Range from 630 nm (visible red) to 830nm (near infrared). The LIGHTWAVE Professional Deluxe base unit contains the power supplies and the control unit. The LED panel can be configured to contain one (1), two (2) or three (3) row(s) of LED (600, 1200 or 1800 LEDs respectively) based on system configuration. The LED panel is attached to the end of the arms and then positioned for patient treatment. The control unit consists of an LCD and keyboard together with the control electronics. The user interface software allows the operator to access and control all device functions.
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