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

    GEMINI OPHTHALMIC SURGERY SYSTEM

    K Number: K911808 · Decision Jun 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    47
    Review Days
    63

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    Basic Information

    Device Name
    GEMINI OPHTHALMIC SURGERY SYSTEM
    K Number
    K911808
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alcon Laboratories
    Date Received
    April 23, 1991
    Decision Date
    June 25, 1991
    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 Alcon Laboratories

    K Number Device Name
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    K000148 RGP MULTI-PURPOSE SOLUTION ID 100136
    K984573 OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP
    K990480 OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER
    K984575 MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
    K983973 OPTI-ONE MULTI-PURPOSE SOLUTION
    K983780 MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
    K981561 LIQUID ENZYME ID 90133
    K981571 MONARCH IOL DELIVERY SYSTEM
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