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510(k) Data Aggregation

    K Number
    K100098
    Device Name
    PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE
    Manufacturer
    JM SYSTEM CO., LTD.
    Date Cleared
    2010-08-13

    (212 days)

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

    PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE

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

    The PlasmaLipo / Plasma D30 Laser Surgical Device is used for delivery of laser light to soft tissue in the contact mode during surgical procedures, including via catheters. The PlamsaLipo / Plasma D30 is generally indicated for incision, excision, vaporizetion, ablation, hemostasis, or coagulation of soft tissue, particularly for laser assisted lipolysis.

    Device Description

    PlasmaLipo / Plasma D30 Laser Surgical Device

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "PlasmaLipo/Plasma D30 Laser Surgical Device." It is an approval letter and does not contain detailed information about acceptance criteria or a study proving the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory obligations for the manufacturer.

    Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory approval based on substantial equivalence, rather than providing a detailed study report with performance metrics and acceptance criteria.

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