LENSAR Laser System Receives 510(k) Clearance for Corneal Pockets, Flaps

April 13, 2018: By Jon Swedien

LENSAR logoLENSAR’s Laser System with Streamline IV has received US FDA 510(k) clearance to perform corneal pockets and flaps for corneal inlay procedures, the Orlando, Florida, company announced April 11.

The system’s new features include a curved-contact patient-interface device that allows surgeons to create the corneal pockets and flaps, LENSAR said.

The company said the device’s new capabilities will be rolled out to US users in 2018.

LENSAR has applied for regulatory approval in the EU and anticipates the new features will be available there in 2018, as well, pending approval, the company said.

The system also features LENSAR’s proprietary augmented reality 3-D model and allows for individual treatment plans, including precise laser delivery and efficient lens fragmentation that can reduce or eliminate the ultrasonic energy delivered into the eye, the company said.

It is the system’s fourth upgrade in two years, LENSAR said.

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