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510(k) Data Aggregation

    K Number
    K221533
    Device Name
    Plasma Shield
    Manufacturer
    Date Cleared
    2022-09-12

    (108 days)

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

    Plasmatica LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Plasma Shield is to be used prior to and during endoscopic procedures to prevent fogging of the scope lens
    Device Description
    The Plasma Shield is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens. The Plasma Shield device is designed for reducing laparoscopic lens fogging by performing cold plasma treatment of a laparoscope lens. The Plasma Shield device is a cold plasma-based device to be used in an operating room, prior to and during laparoscopic procedures. The cold plasma creates a super hydrophilic scope lens surface after treatment (aka activation). The device does not interact directly with the patient's body.
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