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510(k) Data Aggregation

    K Number
    K243854

    Validate with FDA (Live)

    Device Name
    Contour Light (CL-100)
    Manufacturer
    Contour Research, LLC
    Date Cleared
    2026-02-13

    (424 days)

    Product Code
    OLI
    Regulation Number
    878.5400
    Type
    Special
    Panel
    General & Plastic Surgery
    Age Range
    18 - 120
    Reference & Predicate Devices
    K202955
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Contour Light CL-100 device is intended for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

    The Contour Light CL-100 device is indicated to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, and pain and stiffness associated with arthritis, for promoting relaxation of the muscle tissue, and to temporarily increase local blood circulation.

    Device Description

    The Contour Research, LLC Contour Light CL-100 device applies a light emitting diode (LED) technology, and is used to perform red light LED-based circumferential reduction of the hips, thighs and waist in adults within a treatment time of 30 minutes. The device is comprised of a panel of LEDs that is adjustable to conform generally to the outer dimensions of the individual being treated, a software controlled console that is used to select and maintain the application of the LED light, a medical-grade power adaptor, and cables that connect to the energy source.

    AI/ML Overview

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