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

    AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38

    K Number: K925254 · Decision Jan 7, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    7
    Review Days
    80

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    Basic Information

    Device Name
    AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38
    K Number
    K925254
    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
    October 19, 1992
    Decision Date
    January 7, 1993
    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
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    K930320 AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR
    K924235 AMO ELITE
    K911998 MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM
    K893199 PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR