BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P990078 · Decision Jun 30, 2000
    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
    HYPERION LTK SYSTEM
    PMA Number
    P990078
    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
    June 30, 2000
    Date Received
    November 3, 1999
    Expedited Review
    N
    Docket Number
    00M-1386

    Advisory Committee Statement

    APPROVAL FOR THE SUNRISE HYPERION(TM) LTK SYSTEM. THE DEVICE IS INDICATED FOR TEMPORARY REDUCTION OF HYPEROPIA IN PATIENTS WITH +0.75 TO +2.5 DIOPTERS OF MANIFEST REFRACTION SPHERICLA EQUIVALENT (MRSE) AT THE SPECTACLE PLANE (WITH CYLINDER LESS THAN OR EQUAL TO +-0.75 DIOPTERS) WHO ARE 40 YEARS OF AGE OR OLDER WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 6 MONTHS, AS DEMONSTRATED BY A CHANGE OF LESS THAN OR EQUAL TO 0.50D IN SPHERICAL, AND CYLINDRICAL COMPONENTS OF THE MANIFEST REFRACS

    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