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510(k) Data Aggregation

    K Number
    K033354
    Device Name
    FEMTEC LASER MICROKERATOME
    Manufacturer
    20/10 PERFECT VISION OPTISCHE GERATE GMBH
    Date Cleared
    2004-02-18

    (121 days)

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

    20/10 PERFECT VISION OPTISCHE GERATE GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FemTec™ Laser Microkeratome is indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
    Device Description
    The FemTec Laser Microkeratome is intended for use in the creation of a corneal flap by producing short bursts of laser pulses, with each laser pulse having a duration on the order of 500 to 1000 femtoseconds ("fs", 10-15 seconds). Microscopic gas bubbles, which form as a result of the laser induced optical breakdown (LIOB), arc created adjacent to each other at a pre-determined depth in the cornea. It is this continuous layer of gas bubbles that create the lamellar corneal dissection plane just like a mechanical microkeratome blade. The FemTec Laser Microkeratome creates a flap under very low vacuum (250 mbar), and delivers the laser energy directly to the stromal layer of the cornea through a disposable PMMA contact lens, referred to as the Patient Interface (PI).
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