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510(k) Data Aggregation

    K Number
    K122593
    Device Name
    PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2
    Manufacturer
    OPTIM LLC
    Date Cleared
    2012-09-13

    (20 days)

    Product Code
    FEH, KNS
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPTIM LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PRECISION Endoscopic Infrared Coagulator with single-use disposable MAXiguide flexible light guide is intended for treatment of hemorrhoids and other lesions in the colon and rectum when used as an accessory to a flexible colonoscope, flexible sigmoidoscope, or other flexible gastrointestinal endoscope.
    Device Description
    This device is designed to coagulate blood and tissue, specifically for treatment of hemorrhoids and small lesions in the colon and rectum, when used as an accessory to a flexible endoscope.
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