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510(k) Data Aggregation

    K Number
    K073000
    Device Name
    LUMAPROBE
    Manufacturer
    Date Cleared
    2008-10-01

    (343 days)

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

    CLAREBLEND, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LumaProbe is intended to provide light to the body. LumaProbe (Red-631) is generally indicated for the treatment of superficial, benign vascular, and pigmented lesions. LumaProbe (Blue-415) is generally indicated for the treatment of dermatological conditions and specially indicated for the treatment of mild to moderate inflammatory acne vulgaris. LumaProbe (IR-830) is generally indicated 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 LumaProbe is a device that utilizes Light Emitting Diodes to provide LED light to the body. The LumaProbe Red, IR and Blue are a visible light source of high spectral purity. They provide uniform or "hot-spot" free illumination. The output is pre-tuned to one wavelength with a narrow spectral bandwidth. The output wavelength of Red is 631 +/- 4nm, IR is 830 +/- nm and Blue is 415 +/- 5nm. The LumaProbe unit contains the power supplies and the control unit; it has the capabilities to power and sequence up to 2 attachable probes depending on the product model, that deliver the light to the skin as they are moved over the skin surface. The STOP button directly on the probes allows the user to immediately remove all power to the probes.
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    K Number
    K073022
    Device Name
    CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830
    Manufacturer
    Date Cleared
    2008-10-01

    (341 days)

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

    CLAREBLEND, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Clareblend Probes are intended to provide light to the body. Clareblend Probe (Red-631) is generally indicated for the treatment of superficial, benign vascular and pigmented lesions Clareblend Probe (Blue-415) is generally indicated for the treatment of dermatological conditions and specially indicated for the treatment of mild to moderate inflammatory acne vulgaris. Clareblend Probe (IR-830) is generally indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffiess; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
    Device Description
    The Clareblend Probes are hand held devices that utilizes Light Emitting Diodes to provide LED light to the body. The hand hold device contains the power supply. The probe will be simply activated by an alternote action ON/OFF pushbutton switch which is located on the top of the probe. The probe when activated anplies full power (100% duty cycle). The OFF button is provided for the user to immediately remove all power to the probes. The probe housing is 100% machined aluminum and has a recessed clear lexanowindow. The device delivers the light to the skin as it moves over the skin. The output is pre-tuned to one wavele. gth a narrow spectral bandwidth. The output wavelength of Red is 631 +/- 4nm, IR is 830 +/- 5mm and Blue is 415 +/- 5nm.
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