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LensAR Laser System receives 510(k) clearance for anterior capsulotomy during cataract surgery

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WINTER PARK, Fla. — LensAR has received 510(k) clearance from the U.S. Food and Drug Administration for its LensAR Laser System for performing anterior capsulotomy during cataract surgery, the company announced.

This follows the release of clinical data from APEC Hospital Mexico City that demonstrated laser capsulotomies are significantly more precise than manual capsulorrhexis regarding diameter and circularity, according to the release.

The LensAR system couples metric and 3-D laser scanning technologies with an advanced tissue cutting laser.

"This is a critical milestone for the company," Randy Frey, founder and CEO of LensAR, said in the release. "Our first cleared indication of what we believe will be many to come in this exciting new field of laser cataract surgery."

LensAR is also developing the LensAR Laser System for treating presbyopia.

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