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510(k) Data Aggregation

    K Number
    K060372
    Device Name
    INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3
    Manufacturer
    INTRA LASE CORP.
    Date Cleared
    2006-08-16

    (184 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTRA LASE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IntraLase® FS Laser is an ophthalmic surgical laser with the following indications for use: - . In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; - . In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; - In lamellar keratoplasty and corneal harvesting; - In the creation of a corneal flap in patients undergoing LASIK surgery or other o treatment requiring initial lamellar resection of the cornea: - . In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty and in the creation of a penetrating cut/incision for penetrating keratoplasty.
    Device Description
    The IntraLase FS Laser is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections and incisions. The cutting action of the IntraLase FS Laser is achieved through precise individual microphotodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.
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