Israeli medical device company Belkin Vision has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its glaucoma laser, the Eagle device.
The Q-switched, 532nm-wavelength, frequency-doubled laser is designed to be used in performing selective laser trabeculoplasty (SLT).
Belkin said that the FDA’s approval of the Eagle marks a significant opportunity in glaucoma management.
As an initial contactless laser designed specifically for this condition, the Eagle offers an automated, non-invasive solution for both patients and healthcare providers in managing glaucoma.
Belkin Vision CEO Daria Lemann-Blumenthal said: “This achievement has been possible thanks to the skill, passion, and dedication of our entire team. We believe that this FDA clearance will have a positive impact on the lives of those affected by glaucoma, offering novel treatment methods and renewed hope for the future.”
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Said to offer several advantages over traditional treatment options, the device administers laser energy directly through the limbus to the trabecular meshwork in a non-contact procedure, eliminating the need for a gonioscopy lens.
Furthermore, it autonomously identifies the target area and executes the laser treatment sequence while an eye tracker adjusts for any eye movement.
Belkin Vision aims to expand access to early laser therapy for more patients with the introduction of Direct-SLT (DSLT) technology.
The automated glaucoma laser treatment DSLT allows ophthalmologists to treat more patients in any location and promotes accessibility to first-line drop-free glaucoma care.
Glaucoma stands as a primary cause of irreversible blindness, impacting 70 million individuals globally.
In May 2022, the company received a CE Mark under Medical Device Regulation from its notified body DEKRA for the Eagle device.
