BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HOYA IS INJECTOR SYSTEM

    K Number: K081346 · Decision Mar 23, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    60
    Applicant Total
    1
    Review Days
    313

    Basic Information

    Device Name
    HOYA IS INJECTOR SYSTEM
    K Number
    K081346
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4300
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    HOYA SURGICAL OPTICS, INC.
    Date Received
    May 14, 2008
    Decision Date
    March 23, 2009
    Product Code
    MSS
    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
    MSS Folders And Injectors, Intraocular Lens (Iol)

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