BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

    PMA: P830064 · Supplement: S003 · Decision May 28, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    4

    Basic Information

    Device Name
    Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
    Trade Name
    NEODYMIUM-YAG OP LASER OPL-3
    PMA Number
    P830064
    Supplement Number
    S003
    Device Class
    FDA Class 2
    Product Code
    LXS
    Generic Name
    Laser, neodymium:Yag, ophthalmic for posterior capsulotomy and cutting pupilla
    Regulation Number
    886.4392
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 28, 1986
    Date Received
    August 8, 1985
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    LXS Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla