BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P960022 · Decision Dec 16, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    SOFLENS66(TM)
    PMA Number
    P960022
    Device Class
    FDA Class 3
    Product Code
    LPM
    Generic Name
    Lenses, soft contact, extended wear
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 16, 1996
    Date Received
    June 28, 1996
    Expedited Review
    N
    Docket Number
    97M-0183

    Advisory Committee Statement

    APPROVAL FOR THE BAUSCH & LOMB(R) SOFLENS66(TM) (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENS FOR EXTENDED WEAR.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LPM Lenses, Soft Contact, Extended Wear