B+L Stellaris receives 510(k) clearance

April 1, 2014

The FDA has granted 510(k) clearance to Bausch + Lomb’s comprehensive surgical platform-the Stellaris PC Vision Enhancement System-for the integrated 523-nm laser and software.

 

Bridgewater, NJ-The FDA has granted 510(k) clearance to Bausch + Lomb’s comprehensive surgical platform-the Stellaris PC Vision Enhancement System-for the integrated 523-nm laser and software.

“This updated technology is another demonstration of Bausch + Lomb’s unwavering commitment to continuous innovation and improvement that is inspired by the evolving needs of our customers and the patients they serve,” said Cal Roberts, MD, chief medical officer, Bausch + Lomb.

With the advance, the surgical platform now offers the following to surgeons’ facilities:

·      A fully integrated 532-nm green laser, which is upgradable for the existing surgical platform and connects within the sterile field.

·      A wireless, dual linear foot pedal that features integrated laser control and improved design offering versatility and flexibility for procedural needs. The pedal and ergonomic footrest aims to improve comfort for longer procedures by reducing pitch.  An optional LIO foot pedal, cable, and headset are also available.

·      A full portfolio of multifunction laser fibers that meet a wide range of procedural needs, including straight, curved, illuminated, and aspirating probes with a soft tip for added security when working close to the retina.

·      A redesigned interface and laser control software that offers improved clarity, enhanced contrast, and ease of use for both surgeons and staff.

 

 

“To address the clinical, efficiency, and value requirements of the ophthalmic surgeon, the (surgical platform) now offers even greater procedural choice and more opportunities to improve surgical outcomes, from the lens to the retina, on a single, integrated fully capable system,” added Dr. Roberts.

 

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