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510(k) Data Aggregation

    K Number
    K150323
    Device Name
    FEMTO LDV Z8 Surgical Laser
    Manufacturer
    SIE AG,Surgical Instrument Engineering
    Date Cleared
    2015-10-23

    (256 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 LDVIM 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 design of the FEMTO LDV™ Z8 is based on the FDA cleared FEMTO LDV™ Z Models Femtosecond Surgical Lasers Z2-Z6. The application of femtosecond lasers in the field of cataract surgery was achieved with extended focusing capabilities and improved visualization based on existing technologies. The FEMTO LDV™ Z8 Femtosecond Surgical Laser uses smaller spots with lower pulse energies at higher repetition rates to achieve tissue dissection.
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