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

    STELLARIS PC VISION ENHANCEMENT SYSTEM

    K Number: K101325 · Decision Aug 17, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    92
    Review Days
    97

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    Basic Information

    Device Name
    STELLARIS PC VISION ENHANCEMENT SYSTEM
    K Number
    K101325
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bausch & Lomb, Inc.
    Date Received
    May 12, 2010
    Decision Date
    August 17, 2010
    Product Code
    HQC
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    Y

    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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