BVI Medical reports that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its new glaucoma surgical system. The Laser Endoscopy Ophthalmic System, or Leos, is a laser-based device designed to lower intraocular pressure (IOP) through a minimally invasive ab interno procedure.

The Leos system combines laser endoscopy with enhanced visualization capabilities and aims to improve glaucoma treatment at earlier stages of the disease and across a broad range of glaucoma types, the company said in a press release. According to BVI, the device integrates into standard surgical workflows and provides a more intuitive approach to endoscopic cyclophotocoagulation (ECP), a procedure that targets aqueous humor production.

BVI said that the safety and effectiveness of the Leos system is supported by data from a randomized controlled trial. Mikhail Boukhny, BVI’s vice president of global research and development, said the device was developed with clinician needs in mind, particularly the challenge of anatomical visualization during surgery.

A full US commercial launch of Leos is expected later this year.