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

    VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551

    K Number: K080803 · Decision Sep 22, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    6
    Review Days
    185

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    Basic Information

    Device Name
    VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551
    K Number
    K080803
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Optisurgical, Inc.
    Date Received
    March 21, 2008
    Decision Date
    September 22, 2008
    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 American Optisurgical, Inc.

    K Number Device Name
    K101561 TX1 TISSUE REMOVAL SYSTEM
    K020527 HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030
    K953538 RM001 REUSABLE
    K953539 DM001 DISPOSABLE PACK
    K952331 AOI LC-40 PHACOEMULSIFIER