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

    ACUVUE OASYS (senofilcon A) with Photochromic Additive

    K Number: K180299 · Decision Apr 10, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    485
    Applicant Total
    12
    Review Days
    67

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    Basic Information

    Device Name
    ACUVUE OASYS (senofilcon A) with Photochromic Additive
    K Number
    K180299
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Johnson & Johnson Vision Care, Inc.
    Date Received
    February 2, 2018
    Decision Date
    April 10, 2018
    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 Johnson & Johnson Vision Care, Inc.

    K Number Device Name
    K210930 ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)
    K200243 ACUVUE (senofilcon A) Soft Contact Lens Multifocal
    K160212 ACUVUE (senofilcon C) Soft Contact Lens
    K141670 ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA
    K100349 VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER
    K073485 VISTAKON (NARAFILCON) A SOFT CONTACT LENS
    K062614 VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY)
    K051900 ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR
    K032340 VISTAKON (GALYFILCON A) SOFT CONTACT LENS
    K024177 ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER
    Search all 12 clearances from Johnson & Johnson Vision Care, Inc. →