BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™

    K Number: K241707 · Decision Jul 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    485
    Applicant Total
    5
    Review Days
    29

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    Basic Information

    Device Name
    OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™
    K Number
    K241707
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Unicon Optical Co., Ltd.
    Date Received
    June 13, 2024
    Decision Date
    July 12, 2024
    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 Unicon Optical Co., Ltd.

    K Number Device Name
    K213216 Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
    K191929 UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
    K182734 Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac
    K141917 UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR