Israeli ophthalmic medical solutions provider BELKIN Vision has secured the US Food and Drug Administration (FDA) 510(k) approval for its Eagle laser device to treat glaucoma.
Eagle is a Q-switched, 532 nm-wavelength, frequency-doubled Nd:YAG laser device, intended for use in selective laser trabeculoplasty (SLT) procedures.
BELKIN Vision said the advanced laser device is designed to provide several advantages over traditional treatment options.
Eagle’s laser energy is delivered directly through the limbus to the trabecular meshwork in a non-contact procedure, eliminating the need for a gonioscopy lens.
The device automatically defines the target location and applies the laser treatment sequence while the eye tracker compensates for any eye movement.
Also, BELKIN Vision introduced Direct-SLT (DSLT) technology for the Eagle laser device.
The technology expands access to early laser therapy for more patients and allows a large number of eye care professionals to perform the procedure.
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.”
According to the medical device company, Glaucoma is a major cause of irreversible blindness.
The Eagle laser device is the first and only contactless laser for glaucoma that provides an automated and non-invasive solution for patients and healthcare professionals.
Its FDA approval provides a significant opportunity in the management of glaucoma and provides patients with expanded treatment options.
Furthermore, The American Academy of Ophthalmology classifies laser trabeculoplasty as an initial or adjunctive therapy for primary open-angle glaucoma, said BELKIN Vision.
In May last year, the Israeli medical device company received the CE Mark approval for Eagle automated, non-contact glaucoma laser treatment, under the Medical Device Regulation (MDR).
