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510(k) Data Aggregation

    K Number
    K170709
    Device Name
    CURVE Laser System
    Manufacturer
    YOLO Medical, Inc.
    Date Cleared
    2017-06-06

    (90 days)

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

    YOLO Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CURVE Laser System is indicated for non-invasive aesthetic treatment for the temporary reduction in circumference of the waist.
    Device Description
    The CURVE Laser System consists of a main console and 4 treatment paddles. The console houses the main electronics, controls and embedded software. The liquid crystal display (LCD) identifies all key treatment parameters. The main console is also equipped with a micro controller that provides automatic calculation of energy output for a specific set of treatment parameters. The treatment paddles are constructed so that each paddle contains 8 laser emission diode sources at a power output of 40mW per laser diode. These treatment paddles are non-thermal and non-invasive, at a wavelength of 630-680.
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    K Number
    K143741
    Device Name
    Lipofina Laser System
    Manufacturer
    YOLO MEDICAL, INC.
    Date Cleared
    2015-04-24

    (114 days)

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

    YOLO MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lipofina Laser System is indicated for non-invasive aesthetic treatment for the temporary reduction in circumference of the waist.
    Device Description
    The Lipofina Laser System (Figure 1) consists of a main console and 8 treatment paddles. The console houses the main electronics, controls and embedded software. The liquid crystal display (LCD) identifies all key treatment parameters. The main console is also equipped with a micro controller that provides automatic calculation of energy output for a specific set of treatment parameters. The treatment paddles are constructed so that each paddle contains 12 laser emission diode sources at a power output of 35mW per laser diode. These treatment paddles are non-thermal and noninvasive, at a wavelength of 658 (central).
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