BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇲🇾 Malaysia

    Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses

    K Number: K180985 · Decision Jun 8, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    485
    Applicant Total
    2
    Review Days
    56

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    Basic Information

    Device Name
    Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses
    K Number
    K180985
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Supervision Optimax Sdn Bhd
    Date Received
    April 13, 2018
    Decision Date
    June 8, 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 Supervision Optimax Sdn Bhd

    K Number Device Name
    K162223 Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)