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510(k) Data Aggregation

    K Number
    K112154
    Device Name
    FEMTO LDV
    Manufacturer
    SIE AG,SURGICAL INSTUMENT ENGINEERING
    Date Cleared
    2012-03-16

    (233 days)

    Product Code
    HQF
    Regulation Number
    886.4390
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SIE AG,SURGICAL INSTUMENT ENGINEERING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface.

    The FEMTO LDV Z4 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for 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 or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that does not enclose a volume of the cornea.

    The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for 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 cornea at a varying depth with respect the corneal surface that may enclose a volume of the cornea.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to SIE AG for their Femto LDV™ Z-Generation Femtosecond Surgical Lasers (models FEMTO LDV Z2, Z4, and Z6). This document is an approval letter, not a study report or clinical trial summary.

    Therefore, it does not contain the detailed information required to answer the request about acceptance criteria, device performance, study methodology, sample sizes, expert qualifications, or ground truth establishment.

    The letter merely states that the FDA has reviewed the 510(k) and determined the device is "substantially equivalent" to legally marketed predicate devices for the stated indications for use. It outlines regulatory requirements and general information but does not include the specifics of the performance testing.

    In summary, the input text does not provide the information needed to fill out the requested table and answer the study-related questions.

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