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The FDA has awarded 510(k) clearance to a proprietary laser system (LensAR, LensAR Inc.) for use for anterior capsulotomy during cataract surgery.
Winter Park, FL
-The FDA has awarded 510(k) clearance to a proprietary laser system (LensAR, LensAR Inc.) for use for anterior capsulotomy during cataract surgery.
"This is a critical milestone for the company. [It marks] 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.
The laser system integrates proprietary ocular measurement and three-dimensional laser scanning technologies with an advanced tissue-cutting laser.
"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," said David F. Chang, MD, medical monitor for the company. He has used the laser system in Mexico.
Louis D. "Skip" Nichamin, MD, a member of the company's medical advisory board, also has had experience using the system. He said, "The application of femtosecond technology to cataract surgery is the most exciting development in ophthalmic surgery in decades. The increased precision of [this] technology can help in the improvement of surgical outcomes while assisting experienced and inexperienced surgeons achieve more consistent results."
For indications other than anterior capsulotomy during cataract surgery, the laser system is an investigational device in the United States.