The U.S. Food and Drug Administration has given 510(k) clearance to LensAR’s next-generation commercial laser system for use in anterior capsulotomy, with and without laser phacofragmentation, during cataract surgery, according to a company press release.
The regulatory action covers the new LensAR system that is in the final stages before commercial launch in the United States, the release said.
“The enhancements that LensAR has made to its technology have been quite impressive and have significantly increased the range of benefits the system can deliver to cataract surgeons,” Louis D. “Skip” Nichamin, MD, a member of LensAR’s medical advisory board and OSN Cataract Surgery Board Member, said in the release.
The system reduces the amount of ultrasound energy needed to complete surgery due to improved cataract fragmentation cutting algorithms that can address all cataract grades, the release said. It also allows for precise measurement of lens tilt and decentration in 3-D to better align the treatment plan with the patient’s position and anatomy.
The system’s footprint has been designed for compatibility within the workflows of various operating room and treatment room layouts, according to the release. The laser head and patient docking system can move to the patient while accommodating a standard patient gurney.