Oertli Receives FDA 510(k) Clearance for Faros Surgical System

Oertli Instrumente announced it has received FDA 510(k) clearance for the Faros anterior cataract surgery system.

According to a company news release, the Faros system offers a compact design and rapid operational readiness, requiring minimal space in operating rooms. It is optimized for fast setup, with a readiness time of under 1 minute, making it ideal for integrating into office-based surgery. Its precision in fluid or vacuum control enables adaptability to different cataract hardness. Its slim footprint and fast setup time can enhance operational efficiency, allowing health care facilities to optimize their surgical schedules.

This 510(k) clearance allows the family of Faros and CataRhex 3 devices to be almost universally available, according to Oertli. The approval also includes all consumables for cataract surgery and emergency vitrectomy.

"For Oertli, this approval marks another step in expanding global market coverage and highlights the company's expertise in securing worldwide approvals. Alongside Faros, the CataRhex 3 family and other Oertli products are fully approved under the European MDR regulatory framework, showcasing Oertli's commitment to compliance and safety in medical technology," the company stated in a news release.