WINTER PARK, Fla., May 18 /PRNewswire/ — LensAR, Inc., the
leading developer of next generation laser technology for cataract
surgery and presbyopia, today announced that the company 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
“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.