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

    DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal

    K Number: K254052 · Decision Feb 13, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    485
    Applicant Total
    43
    Review Days
    58

    Basic Information

    Device Name
    DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal
    K Number
    K254052
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alcon Laboratories, Inc.
    Date Received
    December 17, 2025
    Decision Date
    February 13, 2026
    Product Code
    LPL
    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
    LPL Lenses, Soft Contact, Daily Wear

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    Other Clearances by Alcon Laboratories, Inc.

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    K243909 Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric
    K242184 Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);
    K233876 UNITY VCS (8065000296); UNITY CS (8065000297)
    K233902 Centurion™ Vision System (Active Sentry™) (8065753057)
    K233856 Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal
    K232921 DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1® Multifocal Toric
    K230785 Precision1, Precision1 for Astigmatism
    K222500 AIR OPTIX COLORS
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