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510(k) Data Aggregation

    K Number
    K142984
    Device Name
    Leo Minor
    Manufacturer
    SUNNEX, INC.
    Date Cleared
    2014-10-29

    (13 days)

    Product Code
    FSY
    Regulation Number
    878.4580
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUNNEX, INC.

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

    The Leo Minor is intended to provide visible illumination of the surgical field and the patient during surgical and non surgical procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets any specific criteria.

    The document is a 510(k) clearance letter from the FDA for a surgical lamp called "Leo Minor." It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. The letter also includes the "Indications for Use" for the device, stating it is "intended to provide visible illumination of the surgical field and the patient during surgical and non-surgical procedures."

    This type of document does not typically include detailed performance data, acceptance criteria, or study results. This information would usually be found in a separate submission document or a scientific publication.

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