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Laser trabeculoplasty to reduce intraocular pressure in patients with poorly controlled intraocular pressure on maximally tolerated medical therapy or prior failed laser trabeculoplasty

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.

The SOLX 790 Titanium Sapphire Laser is a medical device intended for laser trabeculoplasty to reduce intraocular pressure in patients with poorly controlled intraocular pressure on maximally tolerated medical therapy or prior failed laser trabeculoplasty. The device's performance was assessed through preclinical and clinical investigations to demonstrate substantial equivalence to a legally marketed predicate device, the COHERENT (LUMENIS) Ultima 2000 Argon Laser (K913127).

1. Table of Acceptance Criteria & Reported Device Performance

The acceptance criteria for the SOLX 790 Titanium Sapphire Laser are based on demonstrating substantial equivalence to the predicate device, K913127, in terms of intended use, safety, and effectiveness. The table below compares the key features and performance parameters of the SOLX 790 with the predicate device. The "Reported Device Performance" column reflects the specifications of the SOLX 790, which are deemed acceptable by showing equivalence or demonstrating that differences do not raise new questions of safety or effectiveness.

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