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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P940013 · Decision Sep 30, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    PRECISION(TM) UV (VASURFILCON)
    PMA Number
    P940013
    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    Approved (Withdrawn)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
    September 30, 1994
    Date Received
    May 6, 1994
    Expedited Review
    N

    Advisory Committee Statement

    FOR THE PRECISION (IV' (VASURFILCON A) HYDROPHILIC CONTACTLENS FOR EXTENDED WEAR. THIS DEVICE IS INDICATED FOR NON-APHAKIC DAILY OREXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING, RINSING, ANDDISINFECTING, AS RECOMMENDED BY THE EYE CARE PRACTITIONER. CANDIDATES TO USETHE PRECISION UV'" HYDROPHILIC CONTACT LENS INCLUDE PERSONS WHO ARE NEARSIGHTED(MYOPIC) AND FARSIGHTED (HYPEROPIC) AND WHO MAY HAVE ASTIGMATISM OF 2.0DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.

    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