FDA clears Faros anterior cataract surgery system
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The FDA granted 510(k) clearance to the Faros anterior cataract surgery system from Oertli Instrumente, according to a press release.
Faros is designed to enhance operational efficiency in cataract surgery through a compact design that takes up less space in the operating room and allows for easy integration into office-based surgery with a fast setup time. It also features adaptability to different levels of cataract hardness through fluid and vacuum control, according to the release.
The company said that the clearance allows the Faros and CataRhex 3 devices, which are approved under the European medical device regulation framework, to be “almost universally available.”
“We are excited to bring Faros to the United States, offering American ophthalmologists a system that integrates seamlessly into their operating theaters and supports the latest standards of patient care,” Thomas Bosshard, co-CEO of Oertli, said in the release. “This approval is not just a certification; it’s a testament to our pursuit of excellence and innovation in eye surgery.”
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