Date Announced: 22 Mar 2011
Latest regulatory clearance brings laser system a step closer to commercial use in the US.
ORLANDO, Fla.--(BUSINESS WIRE)--LensAR, Inc., the leading developer of next-generation laser technology for refractive cataract surgery, announced today that the company has received 510(k) clearance from the FDA for use of the LensAR™ Laser System for anterior capsulotomy and lens fragmentation during cataract surgery.
“Receiving the additional FDA indication for lens fragmentation is a significant milestone achievement in getting our technology one step closer to commercialization. We are very pleased with the exceptional fragmentation data that was submitted to obtain the indication and the resulting FDA clearance,” said Randy Frey, founder and Chief Executive Officer of LensAR™.
Louis “Skip” Nichamin, MD, went on to comment, “In 2010, I was honored to be the first US surgeon to use the LensAR™ Laser System. I found that even in the most advanced grades of cataract that the lens fragmentation and extraction process was considerably more proficient and seamless than conventional phacoemulsification. The recent FDA clearance is a tremendous accomplishment in advancing innovative technologies that will improve lens replacement surgery.”
The LensAR™ Laser System has been developed to meet the advancing needs of refractive cataract surgeons and their patients. The proprietary 3D-CSI™ (Confocal Structured Illumination) imaging and biometry system is being designed to image and analyze the anatomy across all grades of cataract to improve proficiency.
Unlike traditional imaging systems, 3D-CSI™ provides clean, low noise images that are both high contrast and high-resolution from the anterior surface of the cornea to the posterior capsule. The precision of the LensAR™ Laser System creates an exact capsulotomy incision size and placement based on IOL selection and fragments high grade cataracts for easier removal.
The LensAR™ Laser System is cleared by the FDA for anterior capsulotomy and lens fragmentation. The system has been used in more than 500 eyes outside the United States to date. For other indications it is an investigational device limited by US law to investigational use only.
Web Site: www.lensar.com