May 19 2010
LensAR reported that it has received FDA’s 510(k) clearance for using its Laser System in anterior capsulotomy while performing a cataract surgery.
LensAR Laser System
The LensAR Laser System incorporates the company’s proprietary 3D laser scanning and ocular measurement technologies in combination with a latest tissue cutting laser.
The data from a clinical trial conducted by the APEC Hospital Mexico City revealed that laser capsulotomies delivered more precise results than the manual capsulorhexis in circularity and in the achieved vs. intended diameter.
The company’s Medical Monitor Dr. David F. Chang said that capsulotomy is a critical step in cataract surgery. It is a vital advance that the centration, sizing and consistency of the capsulotomy can be now improved through automation, he noted. The CEO and founder of LensAR, Randy Frey, stated that this is an important milestone for them.
A member of the Medical Advisory Board, Dr. Louis D. "Skip" Nichamin said that the higher precision of this technology can help to enhance the surgical results and at the same time aid the surgeons to get more consistent outcomes.