BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);

    K Number: K242184 · Decision Dec 4, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    39
    Applicant Total
    43
    Review Days
    132

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    Basic Information

    Device Name
    Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);
    K Number
    K242184
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alcon Laboratories, Inc.
    Date Received
    July 25, 2024
    Decision Date
    December 4, 2024
    Product Code
    MPA
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MPA Endoilluminator

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    Other Clearances by Alcon Laboratories, Inc.

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    K230785 Precision1, Precision1 for Astigmatism
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