BELKIN Vision, a provider of ophthalmic medical solutions, said the FDA has granted 510(k) clearance for its glaucoma laser, the Eagle device. A Q-switched, 532 nm-wavelength, frequency-doubled Nd:YAG laser, the Eagle is intended for use in performing selective laser trabeculoplasty (SLT).
Glaucoma is a leading cause of irreversible blindness, affecting 70 million people worldwide with more than 3.6 million diagnosed patients in the US alone. The clearance of the Eagle by the FDA represents a significant opportunity in the management of glaucoma, as the first and only contactless laser for glaucoma, providing an automated and non-invasive solution for patients and healthcare professionals alike. The American Academy of Ophthalmology recognizes laser trabeculoplasty as an initial or adjunctive therapy in patients with primary open angle glaucoma.
The Eagle uses laser energy that's delivered in a non-contact procedure directly through the limbus to the trabecular meshwork without the need for the use of a gonioscopy lens. In addition, the device automatically defines the target location then applies the laser treatment sequence while the eye tracker compensates for any eye movement. By introducing Direct-SLT (DSLT), a streamlined, user-friendly technology, BELKIN Vision aims to expand access to early laser therapy for more patients by enabling a larger number of eye care professionals to perform the procedure.