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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
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for the Cynosure Cellulaze™ Laser. It does not contain the detailed information required to answer the prompt regarding acceptance criteria and performance studies. The letter only states that the device is "substantially equivalent" to legally marketed predicate devices 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)".

    Without the actual 510(k) submission or a summary of safety and effectiveness, it's impossible to extract the specific data requested in the prompt. Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, or comparative effectiveness studies.

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