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510(k) Data Aggregation

    K Number
    K202442
    Device Name
    Carewear Firefly Wrinkle Reduction
    Manufacturer
    Carewear Corp.
    Date Cleared
    2020-11-19

    (85 days)

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

    Carewear Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Carewear® Firefly® Wrinkle Reduction device is an over the counter, battery operated, wearable device which emits energy in the red region of the spectrum, specifically indicated to treat fine lines and wrinkles.
    Device Description
    The Carewear® Firefly® Wrinkle Reduction device is an over the counter, battery operated, wearable device which emits energy in the red region of the spectrum.
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