Bausch + Lomb Receives FDA 510(k) Clearance for Stellaris Elite Phacoemulsification Platform

Source: Bausch + Lomb

Thursday, April 06, 2017 | FDA Approval/Clearance , Product Releases , Bausch+Lomb


Bausch + Lomb announced that it has received 510(k) clearance from the FDA for the Stellaris Elite vision enhancement system, the company’s next generation phacoemulsification platform. The machine offers many new cutting-edge innovations, as well as the opportunity to add upgrades and enhancements continuously, allowing surgeons to customize their machines and expand their capabilities more rapidly than ever before, according to a company news release.

“Bausch + Lomb maintains constant communication with surgeons and uses feedback to ensure that we are innovating to meet their needs,” Chuck Hess, vice president and general manager, U.S. Surgical, Bausch + Lomb, said in the news release. “We know that our customers are looking for a surgical system that will deliver responsiveness and maximum control throughout  every moment of the procedure while having the latest technology machine very cost effectively, and that’s exactly what we’ve designed Stellaris Elite to do.”

Stellaris Elite will be the first phacoemulsification platform on the market to offer Adaptive Fluidics, which combines precise aspiration control with predictive infusion management to create a highly responsive and controlled surgical environment for efficient lens removal. This system aims to reduce IOP fluctuation and postocclusion surge through variable infusion pressure in response to changes in vacuum levels.

The new platform also features Attune energy management system, which utilizes highly efficient, longitudinal cutting to complement Adaptive Fluidics. Attune energy management works synergistically with the chamber stability and vacuum efficiency of Adaptive Fluidics to deliver efficient, low energy controlled emulsification.

Bausch + Lomb, the leader in dual function ophthalmic surgical systems, plans to launch Stellaris Elite for retina applications this summer, which will integrate both retina and cataract capabilities into a single machine. It will offer additional functionality and broad range of accessories and probes, including the exciting new Vitesse technology, which is currently under FDA review.   


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