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510(k) Data Aggregation

    K Number
    K011677
    Device Name
    MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER
    Manufacturer
    CONTINUUM ELECTRO-OPTICS, INC.
    Date Cleared
    2001-06-22

    (23 days)

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

    MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER

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

    • Tattoo Removal
    • Treatment of Vascular Lesions
    • Treatment of Pigmented Lesions
    • Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology

    Device Description

    The MedliteTM C3 Q-Switched Nd:YAG Laser bases its design/construction from the integration of primary subsystems extracted from legally marketed predicate Continuum products. The new device performs and is specified within all product parameters of the predicate devices.

    AI/ML Overview

    The provided 510(k) summary for the Medlite™ C3 Q-Switched Nd:YAG Laser explicitly states "None" for both "Nonclinical Performance Data" and "Clinical Performance Data".

    Therefore, no information is available within this document to answer the requested questions regarding acceptance criteria and a study demonstrating the device meets those criteria. The device was found substantially equivalent to predicate devices based on its design/construction and performance within product parameters of those predicates, not on new performance data.

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