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510(k) Data Aggregation

    K Number
    K131207
    Device Name
    FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER
    Manufacturer
    SURGICAL INSTRUMENT ENGINEERING AG
    Date Cleared
    2013-10-09

    (163 days)

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

    SURGICAL INSTRUMENT ENGINEERING AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for the use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the comea at a varying depth with respect to the corneal surface. In addition, the FEMTO LDV Z6 Surgical Laser is intended for use in patients undergoing cataract surgery for the creation of single-plane, multi-plane, partial thickness and full thickness cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
    Device Description
    Corneal dissection with the FEMTO LDV Z6 Femtosecond Surgical Laser is achieved through precise individual microphotodisruptions of tissue, created by tightly focused ultrashort optical pulses which are delivered through an applanation window assembly while fixating the eye under a vacuum.
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