FDA clears 532 nm laser for Stellaris system
The Stellaris PC Vision Enhancement System has received 510(k) clearance from the U.S. Food and Drug Administration for the integrated 532 nm green laser and software, Bausch + Lomb announced in a press release.
The laser can be upgraded for existing Stellaris systems.
The system has a wireless, dual linear foot pedal with integrated laser control and improved versatility and flexibility. The pedal and foot rest reduce pitch, which improves comfort during longer procedures. An optional LIO foot pedal, cable and headset are available, the release said.
Multifunction laser fibers, a redesigned interface and laser control software are also offered.
The system can be used for posterior segment, anterior segment and combined procedures.