LensAR Laser System Receives FDA Clearance for Use in Cataract Surgery
Author: LensAR, Inc.
Synopsis and Key Points:
Clearance from the FDA for use of the LensAR Laser System for anterior capsulotomy during cataract surgery.
Main DigestLensAR Laser System Receives FDA Clearance for Use in Cataract Surgery - 510(k) Clearance for Anterior Capsulotomy is Major Step Forward for LensAR, Inc.
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 circularity.
"The capsulotomy is arguably the most critical and precise step in cataract surgery and the ability to improve its sizing, concentration, 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.
LensAR, Inc. is the leading developer of next generation laser technology for cataract surgery and presbyopia. The LensAR Laser System, which integrates an advanced ultra short pulse laser with propriety ocular measurement and laser scanning technologies, is being designed to allow physicians to perform several of the steps in cataract surgery (capsulotomy, lens fragmentation, precise astigmatic corrections and unique clear corneal incisions) in a single laser procedure. In addition to advancing its laser technology in the area of cataract surgery, the company is also developing the LensAR Laser System for the treatment of presbyopia.
For more information on LensAR and its laser technology, please visit our website at www.lensar.com
The LensAR Laser System is cleared by the FDA for anterior capsulotomy. For other indications it is an investigational device limited by United States law to investigational use only.
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