BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

    PMA: P850083 · Supplement: S005 · Decision Sep 30, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
    Trade Name
    VISULAS ND:YAG LASER
    PMA Number
    P850083
    Supplement Number
    S005
    Device Class
    FDA Class 3
    Product Code
    LOI
    Generic Name
    Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 30, 1987
    Date Received
    August 12, 1987
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    LOI Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary