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

    ELITA™ Femtosecond Laser System, ELITA™ Patient Interface

    K Number: K223566 · Decision Apr 14, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    46
    Applicant Total
    4
    Review Days
    136

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    Basic Information

    Device Name
    ELITA™ Femtosecond Laser System, ELITA™ Patient Interface
    K Number
    K223566
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Johnson & Johnson Surgical Vision, Inc.
    Date Received
    November 29, 2022
    Decision Date
    April 14, 2023
    Product Code
    OOE
    Advisory Committee
    Ophthalmic
    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
    OOE Ophthalmic Femtosecond Laser

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