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510(k) Data Aggregation

    K Number
    K043377
    Device Name
    ZENO
    Manufacturer
    TYRELL, INC.
    Date Cleared
    2005-06-01

    (175 days)

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

    TYRELL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Zeno is indicated for the treatment of individual actic pimples in persons with mild to moderate inflammatory acne.
    Device Description
    Zeno is a portable hand-held device that produces accurately controlled low level sustained heat for use in treating dermatological disorders, specifically, mild to moderate acne. Individual acne blemishes are treated for a preset time of 2 ½ minutes at a preset temperature. The treatment tip is made from a biocompatible material and delivers the specific low-level heat to the individual acne blemish. The device is powered by rechargeable AAA nickel-metal hydride batteries.
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