BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Lenses, Soft Contact, Daily Wear

    PMA: P850079 · Supplement: S028 · Decision Aug 1, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135

    Basic Information

    Device Name
    Lenses, Soft Contact, Daily Wear
    Trade Name
    HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHALICON B) SOFT (HYDROPHILIC) CONTACT LENSES
    PMA Number
    P850079
    Supplement Number
    S028
    Device Class
    FDA Class 2
    Product Code
    LPL
    Generic Name
    Lenses, soft contact, daily wear
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 1, 1996
    Date Received
    July 12, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REFORMATTING THE PACKAGE INSERT, PROFESSIONAL FITTING AND INFORMATION GUIDE, AND PATIENT INSTRUCTIONS. THE MODIFIED LABELING DOES NOT RESULT IN CHANGES IN THE INDICATIONS FOR USE FOR THE DEVICES

    Classifications

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

    Product Code Device Name
    LPL Lenses, Soft Contact, Daily Wear