BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P890012 · Supplement: S004 · Decision Sep 12, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    GENTLE TOUCH UV (NETRAFILCON) SOFT CONTACT LENSES
    PMA Number
    P890012
    Supplement Number
    S004
    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
    September 12, 2000
    Date Received
    March 25, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1) A CHANGE IN MANUFACTURING METHOD FROM LATHE-CUT TO CAST-MOLDED; 2) A CHANGE IN HANDLING TINT FROM VAT DYES TO D & C GREEN #6; 3) TO ADD AN ULTRAVIOLET ABSORBER INTO NETRAFILCON A LENS MATERIAL; 4) AN ALTERNATE MANUFACTURING SITE AT WESLEY JESSEN PBH, LTD., SOUTHAMPTON, UNITED KINGDOM; 5) MODIFICATION TO THE INDICATINOS FOR USE INCLUDING THE SENTENCE "GENTLE TOUCH(TM) UV (NETRAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES HELP TO PROTECT AGAINST THE TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE"; AND 6) MODIFICATION OF THE NOTE AND WARNING IN LABELING.

    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