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510(k) Data Aggregation

    K Number
    K200616
    Device Name
    E>EyeC
    Manufacturer
    E-SWIN
    Date Cleared
    2020-06-11

    (94 days)

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

    E-SWIN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The E>Eye is a prescription device intended for the treatment of rosacea.
    Device Description
    The E>Eye C is an intense pulsed light system composed of a base housing the electric and electronics sub-assemblies, and a handheld piece "applicator" connected to the base by a cord. The applicator contains the source of optical radiation.
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