The U.S. Food and Drug Administration granted 510(k) clearance to the Victus femtosecond laser platform, designed to be used in both cataract and corneal procedures, according to a news release from Bausch + Lomb and Technolas Perfect Vision.
The platform is cleared for creation of a corneal flap for LASIK surgery or other treatment requiring initial lamellar resection of the cornea and anterior capsulotomy during cataract surgery, the release said.
“Cataract surgery, in its traditional form, delivers excellent results, and is arguably one of the safest and most successful surgical procedures performed anywhere in the body. The opportunity to further improve the outcomes of cataract surgery is something I am proud to be a part of,” Steven J. Dell, MD, of Dell Laser Consultants in Austin, Texas, said in the release.
The Victus platform may offer greater precision compared to manual cataract surgery techniques by allowing for more precise, controllable and centered capsulotomy, according to the release.
“The Victus platform represents a major advancement for ophthalmic surgeons that can potentially enhance patient outcomes,” Kristian Hohla, PhD, chief executive officer of Technolas, said in the release. “We look forward to the continued commercialization of the technology around the world, so that ophthalmic surgeons can experience its potential for themselves.”
The platform received CE mark approval in Europe in December and is now available for shipment in the United States. The companies plan to submit additional indications to the FDA.
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