Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K163257
    Device Name
    VitreOx Anti-fog Solution
    Manufacturer
    SiO2 Nanotech, LLC
    Date Cleared
    2017-05-24

    (191 days)

    Product Code
    OCT, GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    SiO2 Nanotech, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VitreOx® is a temporary anti-fog coating and therein defogs devices such as a laparoscopic accessory intended to facilitate intraoperative defogging of the laparoscope lens thereby maintaining visualization of the surgical site.
    Device Description
    The device, VitreOx®, is a biocompatible, aqueous solution, when used as indicated. In addition, the solution is alcohol-free. It functions in the same manner as the predicate device. The device is intended to be used prior and during minimal invasive surgeries, to prevent fogging of the lens of devices (laparoscope) that provide visualization during the procedure. The device accessory VitreOx®, can be removed from the lens with typical surgical cleaning methods such as scrubbing with soap and water, autoclaving, etc. It is a sterile, single-use, disposable, long-lasting (beyond average surgery time of 90 minutes) anti-fog solution that can be applied on endoscope and laparoscope lenses, as well as endoscope sheaths. It is effective instantaneously, wet; but is even more lasting if allowed to dry, or applied prior to surgery to lenses.
    Ask a Question

    Page 1 of 1