Lensar said today it won FDA 510(k) clearance for its Lensar Laser System with Streamline IV designed to create corneal pockets and flaps used in presbyopia treatments.
With the new clearance, the Lensar Laser System is now indicated for use in procedures to implant presbyopic inlay devices, the Orlando, Fla.-based company said.
The newly cleared features of the Lensar Laser System with Streamline IV include a curved contact patient interface that enables the creation of corneal pockets and flaps, and will be launched to Lensar users this year.
“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. 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,” Dr. Gregory Parkhurst of Parkhurst NuVision said in a prepared statement.
Lensar said it has applied for regulatory approval in the European Union and it is hopeful it will receive approval for the new features later this year.
“The continued expansion of capabilities with the Lensar Laser System is the latest demonstration of our commitment to technological innovation that serves surgeons pursuing excellent visual outcomes for their patients. Lensar’s technology is known for its adaptability and high-quality treatment capability. It made sense to evolve our platform to support surgeons meeting the increasing patient demand with options for the treatment of presbyopia with corneal inlay devices,” CEO Nicholas Curtis said in a press release.
In December 2016, Lensar filed for Chapter 11 bankruptcy protection, saying it needs to reduce its debt and strengthen its balance sheet and platform for future growth.