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510(k) Data Aggregation

    K Number
    K050950
    Device Name
    MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS
    Manufacturer
    ACTIVE OPTICAL SYSTEMS, LTD./EFRAIM BIDAS
    Date Cleared
    2005-04-29

    (14 days)

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

    ACTIVE OPTICAL SYSTEMS, LTD./EFRAIM BIDAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Crystal , Record & Optima are generally intended for dermatological use. The device is specifically indicated for removal of hair by using selective light energy.
    Device Description
    The Crystal & Record are two models of the same device. The Optima is an additional commercial name of the Record. The device applies photothermal energy to human skin tissue to effect a desired change in the structure of the tissue. The energy is transmitted from a light source to the target tissue by a Treatment Handpiece that is in contact with the skin.
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