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510(k) Data Aggregation

    K Number
    K993154
    Device Name
    LASER PHOTOLYSIS SYSTEM, PHARO OPHTHALMIC SURGERY SYSTEM
    Manufacturer
    A.R.C. LASER CORP.
    Date Cleared
    2000-06-29

    (282 days)

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

    A.R.C. LASER CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. The Laser Photolysis System is indicated for use in fragmentation and removal of the cataractous crystalline lens. 2. The Pharo Ophthalmic Surgery System is indicated for use in anterior and posterior ophthalmic surgery.
    Device Description
    Pharo Ophthalmic Surgery System is a class II ophthalmic surgical system intended for use in anterior and/or posterior segment ocular surgery. Functions include Irrigation/Aspiration, Ultrasound phacoemulsification, Bipolar diathermy, pneumatic vitrectomy, pneumatic cutters scissors, air and oil infusion system, and illumination. The user interfaces include a foot controller and a touch screen control panel. The vaccuum system utilizes either a venturi or peristaltic pump system. Peripherals include the printer module, cart and trolley. Accessories include an electric or manual infusion pole, cutters in several models, vitrectomes in several models, diathermy forceps and pencils in several models, ultrasound handpieces in either of two models, I/A handpieces in several models, fiber optic cables for illumination in several models, air exchange sets, tubing sets, and collection cassettes. The Photolysis System is intended for use in Laser fragmentation of cataracts. The device consists of a laser console, which delivers energy by fiber optic via a disposable probe. The probe converts the laser light energy into acoustic energy, which is used to fragment the crystalline lens. The system is controlled by push buttons on the front panel and via footswitch. Irrigation/aspiration is provided by the Pharo system. Accessories include the laser photolysis probe and a dedicated irrigation handpiece.
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