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510(k) Data Aggregation

    K Number
    K213559
    Device Name
    FEMTO LDV Z8 Femtosecond Surgical Laser
    Manufacturer
    SIE AG, Surgical Instrument Engineering
    Date Cleared
    2022-04-21

    (168 days)

    Product Code
    OOE
    Regulation Number
    886.4390
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIE AG, Surgical Instrument Engineering

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FEMTO LDV™ Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface. In addition, the FEMTO LDV™ Z8 Surgical Laser is intended for use in the creation of capsulotomy, phacofragmentation and the creation of single plane, multi-plane, arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
    Device Description
    The FEMTO LDV™ Z8 Femtosecond Surgical Laser is a solid state femtosecond laser used in ophthalmology. It is used for producing cuts in ocular tissue and can be used in corneal and cataract surgery. The Z8 produces femtosecond laser energy that is absorbed by the tissue, resulting in plasma formation. This plasma rapidly expands, creating a cavitation bubble separating the tissue. This process is known as photodisruption. Because of its very short pulse duration, femtosecond laser technology deploys low pulse energy that virtually eliminates damage peripheral to the incision site and can therefore be used to dissect tissue on a microscopic scale. Femtosecond laser systems may use closer spot spacing to overlap these cavitation regions, producing less tissue bridges. The FEMTO LDV™ Z8 Femtosecond Surgical Laser system consists of the following functional units: - Base Station (BS), integrating the Laser Cavity, Fixed Mirror Articulated Arm (FMAA), Power -Supply, Computer, Touchscreen Monitor, Suction Unit, OCT Box, and Safety System - Handpiece (HP) integrating the Cutting Lens and Topview Camera - Disposable accessories
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