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510(k) Data Aggregation

    K Number
    K213830
    Device Name
    Home use hair removal device, model: Precise Touch Pro
    Date Cleared
    2022-02-01

    (55 days)

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

    Iluminage Beauty Co., Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Home use hair removal device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
    Device Description
    The Precise Touch Pro Home use hair removal device is a personal. light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology to perform hair removal. The device mainly consists of IPL main body, AC adapter and device stand three parts and it is only powered by the external power adapter, as well as the treatment window located in the main body which is the source of optical radiation, namely a Xenon flashlamp and the built-in skin sensor to detect the body skin area. If the device is not properly applied to the expected treatment area (in full contact with the skin), the device cannot be automatic triggered a pulse emitting.
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