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Topcon receives 510(k) clearance for ophthalmic laser system
SANTA CLARA, Calif. — The U.S. Food and Drug Administration has granted 510(k) clearance to Topcon Medical Laser Systems to market its PASCAL Streamline 577 laser system, the company announced in a news release.
The Streamline 577 is a solid-state, true-yellow 577-nm wavelength system with pattern-scanning capabilities for treating anterior and posterior ophthalmic disorders such as diabetic retinopathy, wet age-related macular degeneration, glaucoma and retinal vascular occlusive disease.
"The innovative software coupled with the Streamline 577 provides a complete solution: a precise, multi-specialty laser system to cater to the discerning surgeon," Hideharu Suzuki, Topcon president and CEO, said in the release. "The Streamline 577 is priced comparatively to our standard 532-nm PASCAL laser, giving physicians ready access to this desirable wavelength and technology."
The Streamline 577 lets surgeons fine-tune laser parameters and enhance patient comfort. The 577-nm wavelength is "macula-friendly," giving physicians more control over laser output and minimizing trauma to the retina.
The new platform retains some features of the 532-nm PASCAL Streamline. New features include printed summaries of procedures and an optional on-board video teaching system with integrated video camera and monitor, according to the release.