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510(k) Data Aggregation

    K Number
    K081774
    Device Name
    SOLX 790 TITANIUM SAPPHIRE LASER
    Manufacturer
    Date Cleared
    2008-09-12

    (81 days)

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

    SOLX INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Laser trabeculoplasty to reduce intraocular pressure in patients with poorly controlled intraocular pressure on maximally tolerated medical therapy or prior failed laser trabeculoplasty
    Device Description
    The SOLX 790 Titanium Sapphire system is a flashlamp-pumped laser intended for use in performing laser trabeculoplasty. The laser operates at a wavelength of 790 nanometers (nm), and delivers user-selectable pulse energies of 30-80 millijoules (mJ), with nominal pulse duration of 8 microseconds (7+2usec) and a nominal spot size of 200 microns (um). A footswitch activates the laser to deliver pulses of laser energy through an optical fiber to a slit lamp. A trained physician then directs the laser pulses exiting the slit lamp to the desired regions of the trabecular meshwork inside the eye using a Goldman goniolens. A low power, visible aiming beam allows the physician to direct the treatment laser pulses.
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