FDA clears 577-nm laser

August 24, 2011

The FDA has granted 510(k) clearance for a solid-state, true-yellow, 577-nm wavelength system (Pascal Streamline 577, Topcon Medical Laser Systems).

Santa Clara, CA-The FDA has granted 510(k) clearance for a solid-state, true-yellow, 577-nm wavelength system (Pascal Streamline 577, Topcon Medical Laser Systems).

The system has pattern-scanning capabilities for treating anterior and posterior ophthalmic disorders including glaucoma, diabetic retinopathy, neovascular age-related macular degeneration, and retinal vascular occlusive disease. It is designed to allow surgeons to perform treatments with exceptional control and efficiency, and offers the ability to tune laser parameters to improve patient comfort.

Maintaining the same features available with another of the company’s lasers (532-nm Pascal Streamline), the new system also has options for providing printed summaries of each procedure, and an optional on-board video teaching system with an integrated video camera and monitor.

“The innovative software coupled with the [new system] provides a complete solution: a precise, multi-specialty laser system to cater to the discerning surgeon,” said Hideharu Suzuki, president and chief executive officer of Topcon Medical Laser Systems.

The new laser is priced comparatively with the company’s standard 532-nm laser, “giving physicians ready access to this desirable wavelength and technology,” Suzuki added.

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