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

    SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS

    K Number: K991995 · Decision Aug 27, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    74

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    Basic Information

    Device Name
    SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS
    K Number
    K991995
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Softchrome, Inc.
    Date Received
    June 14, 1999
    Decision Date
    August 27, 1999
    Product Code
    MZD
    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
    MZD System, In-Office Tinting, Contact Lenses