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

    ALCON ULTRACHOPPER

    K Number: K091777 · Decision Oct 20, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    16
    Review Days
    125

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    Basic Information

    Device Name
    ALCON ULTRACHOPPER
    K Number
    K091777
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alcon Research, Ltd.
    Date Received
    June 17, 2009
    Decision Date
    October 20, 2009
    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 Research, Ltd.

    K Number Device Name
    K161794 CENTURION Vision System (Active SentryTM)
    K170520 HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+
    K141065 CONSTELLATION VISION SYSTEM
    K121031 WAVELIGHT FS200 PATIENT INTERFACE 1505
    K112977 MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)
    K110951 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA
    K110166 CLEARCUT S SAFETY KNIFE
    K102860 ALCON MULTI-PIRPOSE DISINFECTING SOLUTION
    K101006 WAVELIGHT FS200 LASER SYSTEM MODEL: FS200
    K093305 ENHANCED ULTRA VIT PROBE
    Search all 16 clearances from Alcon Research, Ltd. →