BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P830037 · Decision Apr 24, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    DURASOFT(R) 3 FOR EXT WEAR
    PMA Number
    P830037
    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    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    April 24, 1984
    Date Received
    July 7, 1983
    Expedited Review
    N
    Docket Number
    84M-0164

    Advisory Committee Statement

    APPROVAL FOR THE DURASOFT 3 (PHEMFILCON A) EXTENDED WEAR HYDROPHILIC CONTACT LENS. THE LENS IS INDICATED FOR UP TO 14 DAYS OF CONTINUOUS WEAR BETWEEN CLEANING AND DISINFECTION (EXTENDED WEAR) BY PERSONS WITH EYES THAT ARE NON-DISEASED, NOT-APHAKIC, HAVE NO MORE THAN 2.00 DIOPTERS (D) OF ASTIGMATISM, AND REQUIRE A SPHERICAL LENS IN THE POWER RANGE FROM -20.00 D TO +0.00 D FOR THE CORRECTION OF NEARSIGHTEDNESS (MYOPIA) OR FARSIGHTEDNESS (HYPEROPIA). THE LENS IS TO BE DISINFECTED USING EITHER A HEAT (THERMAL) OR A CHEMICAL (NOT HEAT) DISINFECTION SYSTEM.

    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