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510(k) Data Aggregation

    K Number
    K151337
    Device Name
    Strialite
    Date Cleared
    2016-02-24

    (281 days)

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

    Centre Light Solutions, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Strialite is an over-the-counter device in the temporary reduction of redness in striae rubra (red stretch marks). Strialite does not remove the stretch marks but may improve their appearance.
    Device Description
    The Strialite is an over the counter (OTC) device utilizing a combination of light emitting diode (LED) lights and a heating element as a phototherapy/thermal treatment for the end users' stretch marks (striae). It is a hand-held, compact, lightweight device, designed to specifically treat and reduce the visible appearance of an individual's red stretch marks. A stretch mark is a defect in the skin caused by damaged collagen that occurs from rapid skin stretching, that may have a red appearance. The red LED light and heat work together to stimulate the skin at the cellular level to produce and repair collagen. As the damaged collagen tissue is gradually replaced, over time the appearance of the stretch mark is reduced. Typical areas for treatment are the abdomen, breasts, back, hips, and thighs. The recommended treatment schedule is two (2) 20-minute sessions a week for at least four (4) weeks. Strialite is intended for home use by adults under the age of 50 years. The Strialite device consists of a housing enclosure with an ergonomic handle, electronic circuit boards, treatment plate with a specific array of LED lights, thermal heating elements that generate temperature up to 105 degree F (40 degree C), touch control power button (On/Off), and a power cord. The flat LED panel, consisting of thirty-five (35) visible red LEDs in the 633 nm (±5nm) spectrum, is located on the base of the device, and directly contacts the area of skin to be treated. The device is provided non-sterile and reusable.
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