FDA 510(k) Clearance for Faros ANTERIOR CATARACT SURGERY SYSTEM
We are proud to announce the U.S. Food and Drug Administration (FDA) 510(k) clearance for the worldwide established Faros anterior cataract surgery system. This milestone underscores our global reach and commitment to providing advanced, reliable surgical equipment worldwide.
The Faros system stands out for its 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 *. Its precision in fluid or vacuum control enables adaptability to different cataract hardness, making it a versatile choice for eye surgeons.
Already proven in millions of cataract surgeries, Faros's precision, robustness, and effectiveness have contributed to reliable surgical outcomes worldwide. Its slim footprint and fast setup time can enhance operational efficiency, allowing healthcare facilities to optimize their surgical schedules.
This 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.
For us, this approval marks another step in expanding global market coverage and highlights our 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.
«We are excited to bring Faros to the United States, offering American ophthalmologists a system that integrates seamlessly into their operating theatres and supports the latest standards of patient care. This approval is not just a certification; it's a testament to our pursuit of excellence and innovation in eye surgery.»
Christoph and Thomas Bosshard, Co-CEO's Oertli Instrumente AG
Efficient and highly effective
The Faros is an efficient and powerful surgical platform for cataract, vitreoretinal and glaucoma surgery *. During surgery, there is no time to work through complex menu structures and clumsy user processes. This is why the Faros surgical platform is systematically designed for user friendliness *.