LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K160691
    Device Name
    Acne Light Therapy Wand
    Manufacturer
    ZUKO, INC.
    Date Cleared
    2016-06-21

    (102 days)

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

    ZUKO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Acne Light Therapy Wand is indicated to treat mild to moderate inflammatory acne.
    Device Description
    The Acne Light Therapy Wand uses known LED light therapy technology for the treatment of acne. A combination of blue light and red light is emitted. The Acne Light Therapy Wand device does not emit any ultraviolet (UV) light. UV light is defined as light with the range of 100-400nm. To use the Acne Light Therapy Wand device, users place the device over the treatment area and press the "On" button on the device to start treatment. The device will automatically turn off after each treatment cycle.
    Ask a Question

    Page 1 of 1