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

    STAAR PHACO XL SMALL INCISION SYSTEM

    K Number: K884241 · Decision Feb 17, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    22
    Review Days
    129

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    Basic Information

    Device Name
    STAAR PHACO XL SMALL INCISION SYSTEM
    K Number
    K884241
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Staar Surgical Co.
    Date Received
    October 11, 1988
    Decision Date
    February 17, 1989
    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 Staar Surgical Co.

    K Number Device Name
    K090161 EPIPHANY INJECTION SYSTEM
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    K032412 RE-USEABLE MICROSTAAR INJECTOR, MSI-S
    K020734 SURGE-FREE ASPIRATION ADAPTER
    K983129 DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)
    K980696 FOAM TIP INJECTOR
    K954600 MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION)
    K913626 SOFTRANS INJECTOR
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