Winter Park, FL-- LensAR, Inc. has received 510(k) clearance from the FDA for use of the LensAR Laser System for anterior capsulotomy during cataract surgery. The LensAR Laser System integrates propriety ocular measurement and 3D laser scanning technologies with an advanced tissue-cutting laser. The clinical data from the APEC Hospital Mexico City showed the laser capsulotomies were significantly more precise than manual capsulorhexis in the intended vs. achieved diameter and in circularity.
"The capsulotomy is arguably the most critical and precise step in cataract surgery and the ability to improve its sizing, centration, and consistency through automation is an important and exciting advance," stated Dr. David F. Chang, LensAR Medical Monitor, who has personally used the LensAR Laser System in Mexico.
Dr. Louis D. "Skip" Nichamin, Medical Advisory Board member, who also has had experience using the system directly, commented, "The application of femtosecond technology to cataract surgery is the most exciting development in ophthalmic surgery in decades. The increased precision of the LensAR technology can help in the improvement of surgical outcomes while assisting experienced and inexperienced surgeons achieve more consistent results."
"This is a critical milestone for the company. Our first cleared indication of what we believe will be many to come in this exciting new field of laser cataract surgery," said Randy Frey, founder and chief executive officer of LensAR.