LENSAR, Inc. has announced last week that its LENSAR® Laser System with Streamline™ IV platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This expands the platform’s capabilities to include the creation of the corneal pockets and flaps used in ophthalmic procedures treating presbyopia.
The LENSAR Laser System with Streamline IV is featured as the only femtosecond laser on the market developed specifically for refractive cataract surgery. The system aims to help surgeons manage astigmatism with extreme treatment planning insights by featuring quick and easy patient docking, as well as superior imaging capabilities. The new presbyopia features of the system include a new curved contact patient interface device that enables the creation of corneal pockets and flaps without compromising patient comfort.
“This latest innovation from LENSAR speaks to the company’s strong partnership with its customers. Adapting the LENSAR platform for stromal pockets and corneal flaps delivers on their promise to expand the platform capabilities to facilitate presbyopia inlay procedures,” said Gregory Parkhurst, M.D., F.A.C.S. of Parkhurst NuVision. “LENSAR has always been open to feedback from its customer base and this clearance is just the latest example of their ability to incorporate the clinical experience with the technology to drive innovation.”
The new presbyopia procedure capabilities will be rolling out to LENSAR users in the U.S. in 2018. LENSAR has applied for regulatory approval in the EU and anticipates availability of the new features there later in the year, pending approval.
The LENSAR Laser System has been cleared by the U.S. Food and Drug Administration for anterior capsulotomy, lens fragmentation, corneal incisions including corneal pockets and flaps, and arcuate incisions. For other indications, it is an investigational device limited by U.S. law to investigational use only.
Read the full press release from LENSAR, Inc.