FDA Approves Five New Performance Upgrades for Lensar Laser System
Lensar has received FDA 510(k) clearance of five new application technologies for its flagship Lensar Laser System. With these additions, collectively referred to as Streamline, the system is the first of its kind to include automation and customization at essential steps of refractive cataract surgeries, the Orlando, Fla., devicemaker announced Wednesday.
Streamline’s wireless integration with preoperative diagnostic devices, using the Cassini Corneal Shape Analyzer, permits preoperative iris registration data capture and maps it to the image of the eye taken under the laser during procedure time. This eliminates having to manually ink mark an eye to identify and adjust for any cyclorotation that can occur during surgery, and abolishes manual data entry errors, the devicemaker said.
Surgeons can use the Streamline arcuate incision planning table to pinpoint the location, depth and extent of an intended arcuate incision. Plans can be saved for later use, maximizing efficiency, the company added.
The Streamline applications include integrated cataract density imaging, which automatically categorizes cataracts to a preprogrammed fragmentation pattern based off cataract density and isolates fragmentation to the nucleus.
Since July 2012, the Lensar Laser System has been used in close to 60,000 cataract surgeries.
The system is indicated by the FDA for anterior capsulotomy, lens fragmentation, and corneal and arcuate incisions. — Jason Scott