根据Bausch + Lomb和Technolas完美愿景的新闻发布,美国食品和药物管理局为维多斯飞秒激光平台授予510(k)间隙,旨在用于白内障和角膜手术。
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.
“维多利斯平台代表了可潜行患者结果的眼科外科医生的主要进步,”Technolas的首席执行官博士博士学位,博士学位在释放中表示。“我们期待着世界各地技术的持续商业化,使眼科外科医生可以体验其自身的潜力。”
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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