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510(k) Data Aggregation

    K Number
    K050696
    Device Name
    MEDLITE C1 Q-SWITCHED ND:YAG LASER
    Manufacturer
    HOYA PHOTONICS, INC.
    Date Cleared
    2005-06-17

    (91 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K042456
    Why did this record match?
    Device Name :

    MEDLITE C1 Q-SWITCHED ND:YAG LASER

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

    The MedLite™ C1 Q-Switched Nd:YAG Laser is intended for: Treatment of Pigmented Lesions Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for the MedLite™ C1 Q-Switched Nd:YAG Laser, which focuses on demonstrating substantial equivalence to a predicate device rather than providing performance data against specific acceptance criteria.

    The "Nonclinical Performance Data" and "Clinical Performance Data" sections both state "None," indicating that no specific performance studies were included in this submission to prove device performance against acceptance criteria.

    Therefore, I cannot extract the requested information from the provided text.

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