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

    METRO SOFT

    K Number: K100244 · Decision Oct 28, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    485
    Applicant Total
    8
    Review Days
    274

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    Basic Information

    Device Name
    METRO SOFT
    K Number
    K100244
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Metro Optics of Austin, Inc.
    Date Received
    January 27, 2010
    Decision Date
    October 28, 2010
    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 Metro Optics of Austin, Inc.

    K Number Device Name
    K233221 Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
    K080512 REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT
    K031532 SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT LENS FOR DAILY WEAR
    K001620 METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT FROM LEN
    K990264 COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS
    K964902 CONTACT LENSES METRO-G 3X (HIOXIFILCON B)
    K961606 METRO FOCAL ASPHERIC (POLYMACON)