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

    AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM

    K Number: K111697 · Decision Sep 27, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    13
    Review Days
    102

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    Basic Information

    Device Name
    AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM
    K Number
    K111697
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott Medical Optics, Inc.
    Date Received
    June 17, 2011
    Decision Date
    September 27, 2011
    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 Abbott Medical Optics, Inc.

    K Number Device Name
    K170322 Catalys Precision Laser System
    K160236 Dual Pump Pack
    K151636 AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control
    K151783 COMPACT INTUITIV Multiple-Use Pack
    K143434 One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series
    K133115 COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK
    K121721 LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)
    K113151 IFS LASER SYSTEM
    K111446 SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM
    K111882 LAMINAR FLOW PHACO TIPS
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