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510(k) Data Aggregation

    K Number
    K091800
    Device Name
    LIPOEZE LASER ASSISTED ASPIRATION CANNULA
    Manufacturer
    CURVE MEDICAL
    Date Cleared
    2009-09-23

    (98 days)

    Product Code
    GEX,DEV
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K933017,K073617
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LipoEze Cannula is a suction hand piece intended for use with a 980nm laser fiberoptic delivery system during laser assisted lipolysis.

    Device Description

    The LipoEze Cannula is a suction hand piece.

    AI/ML Overview

    This document is a 510(k) premarket notification for the LipoEze Cannula, a medical device. It does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it focuses on the administrative aspects of a 510(k) submission, confirming substantial equivalence to predicate devices.

    Therefore, I cannot provide the requested information.

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