LensAR has announced it has received FDA 510(k) clearance for company's next-generation LensAR Laser System for use in anterior capsulotomy, with and without laser phacofragmentation during cataract surgery, according to a news release.
The system includes a number of features, including technology for 3D-imaging measurement and beam-guided delivery, precise measurement of lens tilt and decentration in 3D and an easily moveable laser head and patient docking system, according to the release.
"Today's regulatory milestone validates all the work our team has put into enhancing our laser platform and moves us one critical step closer to the commercialization of the LensAR Laser System in the United States," said Nick Curtis, LensAR's CEO, in the release. "With final preparations for our U.S. commercial launch underway, we are excited to begin working with cataract surgeons across the country to integrate our leading laser technology into their practices."
To date, commercial LensAR Laser Systems have been installed at the Instituto de Ojos Sacro Cuore in Lima, Peru, and the Asian Eye Institute in the Philippines.
LensAR is headquartered in Orlando, Fla.
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