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

    CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES

    K Number: K994320 · Decision Oct 20, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    4
    Review Days
    303

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    Basic Information

    Device Name
    CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES
    K Number
    K994320
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cantor & Silver , Ltd.
    Date Received
    December 22, 1999
    Decision Date
    October 20, 2000
    Product Code
    NCZ
    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
    NCZ Lens, Contact, For Color Vision Deficiency

    Other Clearances by Cantor & Silver , Ltd.

    K Number Device Name
    K992500 CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS
    K990757 CANTOR & SILVER 5X TINTED (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT WEAR CONTACT LENS, TINTED (TRANSPA
    K981779 CANTOR & SILVER 5X (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINTED, LAT