BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Excimer Laser System

    PMA: P930016 · Supplement: S053 · Decision Jun 15, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    10

    Basic Information

    Device Name
    Excimer Laser System
    Trade Name
    iDESIGNRefractive Studio, STAR Excimer Laser System
    PMA Number
    P930016
    Supplement Number
    S053
    Device Class
    FDA Class 3
    Product Code
    LZS
    Generic Name
    Excimer laser system
    Medical Specialty
    Unknown
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 15, 2018
    Date Received
    September 29, 2017
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval to upgrade the software and hardware to its combined corneal topographer and wavefront aberrometry device, the iDesign Advanced WaveScan Studio System, and expansion of the indications for use of the iDesign system, in combination with the STAR S4 IR Excimer Laser Systems, to include the monovision treatment of myopic presbyopes. The device, as modified, will be marketed under the trade name iDesign Refractive Studio, STAR Excimer Laser System and is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) to achieve monovision by the targeted retention of myopia (-1.25 to -2.00 D) in the non-dominant eye of presbyopic myopes: 1) 40 years or older who may benefit from increased spectacle independence across a range of distances with useful near vision,;2) with myopic astigmatism up to -6.00 D spherical equivalent as measured by iDESIGN® Refractive Studio, with cylinder up to -3.00 D, and a minimum pre-operative myopia in their non-dominant eye at least as great as their targeted myopia; 3) with an agreement between manifest refraction (adjusted for optical infinity) and iDESIGN® Refractive Studio refraction as follows: a. Spherical Equivalent: Magnitude of the difference is less than 0.625 D. b. Cylinder: Magnitude of the difference is less than or equal to 0.5 D. c. Cylinder Axis: If either the manifest cylinder entered into the iDESIGN® Refractive Studio or the iDESIGN® Refractive Studio cylinder selected for treatment is less than 0.5 D, there is no requirement for axis tolerance. When both cylinders have a magnitude of at least 0.5 D, the axis tolerance is linearly reduced from 15>= (0.5 D) to 7.5 >= (7.0 D or greater) based on the average magnitude of both cylinders;4) with documented evidence of a change in manifest refraction of no more than +0.5 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination; and 5) with a successful preoperative trial of monovision or history of monovision experience.

    Classifications

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

    Product Code Device Name
    LZS Excimer Laser System