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510(k) Data Aggregation

    K Number
    K172111
    Device Name
    Vevazz LED
    Manufacturer
    Date Cleared
    2017-11-22

    (132 days)

    Product Code
    Regulation Number
    878.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vevazz, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vevazz LED can be used to provide the non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.
    Device Description
    The Vevazz is a non-invasive red-light system. The device is a moderately complex device that consists of a base unit that plugs into 120 VAC or 240 VAC main power with Ground (earth) and a 2 amp 250 VAC Fuse. The base unit can support up to 16 large LED paddles and 4 small LED paddles. The connections on the base are female phono jacks that are low voltage having a maximum electrical output of 16 VDC @ .5 amps for a total of 8 Watts per port. The large paddles consist of 28 LEDs in a series/parallel electrical connection that has a cord with a male phono jack. Small paddles consist of 4 LEDs and have matching electrical characteristics as the large paddles. Each LED produces 50 mw/cm2 of light energy with a wavelength of 650 nm; +/- 25 nm uniformly over the treatment area without producing hot spots. Treatment time is preset to 7 minutes for non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.
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    K Number
    K162763
    Device Name
    Vevazz LED Heat Lamp
    Manufacturer
    Date Cleared
    2017-01-05

    (97 days)

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

    Vevazz, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vevazz is a device that emits energy in the infrared spectrum and is to be used to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, arthritis, stiffness or muscle spasms; the temporary increasing of local blood circulation and/or the temporary relaxation of muscle.
    Device Description
    The Vevazz device is a moderately complex device that consists of a base unit that plugs into 120 VAC or 240 VAC main power with Ground (earth) and a 2 amp 250 VAC Fuse. The base unit can support up to 16 large LED paddles and 4 small LED paddles. The connections on the base are female phono jacks that are low voltage having a maximum electrical output of 16 VDC @ .5 amps for a total of 8 Watts per port. The large paddles consist of 28 LEDs in a series/parallel electrical connection that has a cord with a male phono jack. Small paddles consist of 4 LEDs and have matching electrical characteristics as the large paddles. Each LED produces 50 mw/cm2 of light energy with a wavelength of 650 nm: +/- 25 pm uniformly over the treatment area without producing hot spots.
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