Oertli Instrumente AG announced FDA 510(k) clearance for the Faros anterior cataract surgery system. This milestone underscores Oertli's global reach and commitment to providing advanced, reliable surgical equipment worldwide, the company said in a press 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 one minute, making it ideal for integrating into office-based surgery. In addition, its precision in fluid or vacuum control enables adaptability to different cataract hardness.

The 510(k) clearance allows the comprehensive family of Faros and CataRhex 3 devices to be almost universally available, meeting the latest safety standards, including new cybersecurity norms. The approval also includes all consumables for cataract surgery and emergency vitrectomy, ensuring that surgeons have access to a complete set of tools for eye care.

According to 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.