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510(k) Data Aggregation

    K Number
    K213557
    Device Name
    Finexel
    Manufacturer
    SNJ Co., Ltd
    Date Cleared
    2022-04-12

    (155 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K231514
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Finexel CO2 laser system is intended for use in non-fractionated mode for Incision, Ablation, Vaporization, and Coagulation of Human body soft Tissues in Dermatology, Plastic surgery, Gynecology, Neurosurgery, and in Podiatry.

    Device Description

    Finexel CO2 Laser System

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about a study that proves a medical device meets acceptance criteria, nor does it include a table of acceptance criteria and reported device performance.

    The document is an FDA 510(k) clearance letter for the "Finexel CO2 Laser System". It states that the device is substantially equivalent to legally marketed predicate devices for specific indications for use. It lists the general controls and regulations that the manufacturer must comply with.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the information provided.

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