FDA clearance


Posted: Friday, December 1, 2017

Topcon Medical Systems has announced that its PASCAL® Synthesis TwinStar™ laser, (combined 577Nm and 638Nm) has received FDA 510(k) clearance. (K170409)
“The Synthesis TwinStar further expands the PASCAL line of laser photocoagulators offering the ability to treat retinal disorders with a 577Nm yellow wavelength or with a 638Nm red wavelength,” said a spokeswoman.
““The yellow module allows doctors to treat with a single spot as well as with a variety of patterns and four spot sizes. The yellow module can also be used with the optional Endpoint Management software for sub-threshold procedures. The red wavelength, ideal for targeting choroidal vessels in the neovascular membrane, is for single spot treatments and has two different spot sizes,” she said.