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510(k) Data Aggregation

    K Number
    K024374
    Device Name
    RMO PLASMA CURING LIGHT
    Manufacturer
    LOKKI LASERS MEDICAUX
    Date Cleared
    2003-03-10

    (69 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RMO PLASMA CURING LIGHT

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

    The RMO Plasma Curing Light is a source of illumination for curing dental restorative materials and is a source of illumination for tooth whitening activities performed in dentistry.

    Device Description

    Not Found

    AI/ML Overview

    This is an FDA 510(k) clearance letter for a dental device, specifically a "RMO Plasma Curing Light." This document does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

    The letter states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA has determined that the new device is as safe and effective as a device already on the market. This often involves comparing the new device's technological characteristics and performance data to that of the predicate device, but the details of such a comparison are not included in this document.

    Therefore, I cannot extract the requested information as it is not present in the provided text.

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