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510(k) Data Aggregation

    K Number
    K123407
    Device Name
    CELLULAZE LASER
    Manufacturer
    CYNOSURE, INC.
    Date Cleared
    2013-03-29

    (144 days)

    Product Code
    OYW
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    OYW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cynosure Cellulaze™ Laser is intended for the improvement in the appearance of cellulite as supported by long-term clinical data (at least 6 months with no observed reduction in treatment benefits up to 9 months of observation).
    Device Description
    Not Found
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    K Number
    K102541
    Device Name
    CYNOSURE CELLULAZE LASER
    Manufacturer
    CYNOSURE, INC.
    Date Cleared
    2012-01-26

    (510 days)

    Product Code
    OYW
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    OYW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cynosure Cellulaze Laser is intended for the short term improvement in the appearance of cellulite.
    Device Description
    The Cynosure Cellulaze laser is an Nd: Y AG laser, with a wavelength of 1440nm. The energy delivering laser optical fiber is housed within a cannula and is combined with the temperature monitoring guide functioning as a safety feature that prevents the laser from generating temperature above the safety range.
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