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LensAR laser system gains 510(k) clearance for corneal incisions in cataract surgery
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The LensAR laser system was granted 510(k) clearance from the U.S. Food and Drug Administration for performing corneal incisions during cataract surgery, according to a news release.
The system now has FDA clearance for all key aspects of laser cataract surgery, including lens fragmentation, anterior capsulotomy with or without phacofragmentation and corneal incisions, the release said.
The laser platform is designed to make use of LensAR’s proprietary high-resolution 3-D imaging measurement technology to provide low-noise images with high contrast from the anterior corneal surface to the posterior capsule of the crystalline lens, according to the release.
The system is being sold in the United States, Europe and several countries elsewhere, the release said.