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

    CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS

    K Number: K080632 · Decision Oct 15, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    99
    Registration Numbers
    99
    Same Product Code
    24
    Applicant Total
    2
    Review Days
    224

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    Basic Information

    Device Name
    CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS
    K Number
    K080632
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clearlab SG Pte, Ltd.
    Date Received
    March 5, 2008
    Decision Date
    October 15, 2008
    Product Code
    MVN
    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
    MVN Lens, Contact, (Disposable)

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    Other Clearances by Clearlab SG Pte, Ltd.

    K Number Device Name
    K192129 ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens