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510(k) Data Aggregation

    K Number
    K073715
    Device Name
    ELIPO
    Manufacturer
    SYNERON MEDICAL LTD.
    Date Cleared
    2008-04-23

    (114 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K062321
    Why did this record match?
    Device Name :

    ELIPO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LipoLite (eLipo) is intended for dermatological procedures requiring incision, excision, vaporization, ablation and coagulation of soft tissue. The LipoLite (eLipo) is further indicated for laser-assisted lipolysis.

    Device Description

    The LipoLite (eLipo) is a microprocessor-controlled 1064 nm Nd: YAG laser system. It is composed of the following main units: high voltage power supply, laser assembly, control panel and cooling unit. The LipoLite (eLipo) delivers pulsed energy to pre-determined anatomical areas via an optical fiber.

    AI/ML Overview

    I am sorry, but the provided text describes a 510(k) submission for a laser surgical instrument (LipoLite/eLipo) and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found for software or AI/ML-based medical devices.

    Therefore, I cannot extract the requested information regarding device performance, sample sizes, expert qualifications, ground truth, or comparative effectiveness studies. This type of information is not present in the provided context, which is primarily a regulatory clearance document for a hardware device, not an AI/ML device.

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