Belkin Vision has received FDA 510(k) clearance for its Eagle device, a Q-switched, 532 nm-wavelength, frequency-doubled Nd:YAG laser developed for selective laser trabeculoplasty (SLT).
The Eagle is positioned by Belkin as the first and only contactless laser for glaucoma, offering an automated and noninvasive solution for patients and healthcare professionals.
An essential feature of the Eagle is its non-contact procedure, delivering laser energy directly through the limbus to the trabecular meshwork without requiring a gonioscopy lens. Furthermore, the device incorporates an automated system for defining the target location and applying the laser treatment sequence. The built-in eye tracker compensates for any eye movement during the procedure, ensuring precision.
Belkin Vision introduces Direct-SLT (DSLT) technology, simplifying the process and making early laser therapy more accessible. This user-friendly approach aims to broaden the range of eye care professionals capable of performing the procedure.
"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," Belkin Vision CEO, Daria Lemann-Blumenthal, said in a company news release.
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