BVI Medical's Leos Laser Receives FDA 510(k) Clearance

The Laser Endoscopy Ophthalmic System is designed for early-stage glaucoma as well as a wide spectrum of glaucoma types.

Ophthalmic Professional April 17, 2025

Clinical Scorecard: BVI Medical's Leos Laser for Glaucoma Receives FDA 510(k) Clearance

Category	Detail
Condition	Glaucoma (early-stage and broad spectrum)
Key Mechanisms	Laser endoscopy with enhanced visualization for endoscopic cyclophotocoagulation targeting aqueous humor production to lower intraocular pressure
Target Population	Patients with early-stage and various types of glaucoma
Care Setting	Surgical ophthalmology settings with standard surgical workflows

Leos system is a minimally invasive ab interno laser device designed to lower intraocular pressure.
Combines laser endoscopy with enhanced visualization to improve anatomical visualization during surgery.
FDA 510(k) clearance supported by randomized controlled trial data demonstrating safety and effectiveness.

Identify glaucoma patients suitable for early-stage or broad spectrum laser surgical intervention.

Utilize Leos system for endoscopic cyclophotocoagulation to reduce aqueous humor production and lower intraocular pressure.

Monitor intraocular pressure post-procedure to assess treatment efficacy and safety.

Consider standard surgical risks associated with minimally invasive laser cyclophotocoagulation procedures.

Patients with early-stage and various types of glaucoma requiring surgical intervention.

Leos system integrates into standard surgical workflows and offers improved visualization to enhance procedural safety and effectiveness.

Incorporate enhanced visualization techniques during endoscopic cyclophotocoagulation to optimize anatomical targeting.
Select patients based on glaucoma stage and type appropriate for minimally invasive laser ab interno procedures.
Follow established surgical protocols integrating the Leos system to ensure procedural consistency.