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510(k) Data Aggregation

    K Number
    K190443
    Device Name
    MMSphere
    Manufacturer
    Galactic Beauty, LLC
    Date Cleared
    2019-06-24

    (119 days)

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

    Galactic Beauty, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MMSphere™Light Therapy Device emits energy in the red, blue and amber regions of the spectrum, specifically indicated to treat wrinkles and/or mild to moderate acne. The MMSphere™is designed to be used for 20 minute treatments three to seven times per week.
    Device Description
    MMSphere™is an OTC, multi-use Light Therapy Device using LED light therapy technology for the treatment of mild to moderate wrinkles and/or acne. The device uses a combination of red light (625nm), blue light (465nm), and amber (605nm) to create different treatment settings. The user will wear provided goggles for treatments. Device can be used with handheld option or placed on a countertop.
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