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

    AMO ELITE

    K Number: K924235 · Decision Dec 23, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    7
    Review Days
    121

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    Basic Information

    Device Name
    AMO ELITE
    K Number
    K924235
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Allergan Medical Optics
    Date Received
    August 24, 1992
    Decision Date
    December 23, 1992
    Product Code
    HQC
    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
    HQC Unit, Phacofragmentation

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    Other Clearances by Allergan Medical Optics

    K Number Device Name
    K951462 AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM
    K941603 AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE
    K930320 AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR
    K925254 AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38
    K911998 MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM
    K893199 PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR