LensAR laser platform garners FDA approval for corneal incisions in cataract surgery
LensAR has received FDA 510(k) clearance for another utility for its LensAR Laser System, which now can perform corneal incisions in refractive cataract surgery.
LensAR (Orlando, FL) has received FDA 510(k) clearance for another utility for its LensAR Laser System, which now can perform corneal incisions in refractive cataract surgery. The system is now cleared by the FDA for all of the critical components of laser cataract surgery, including lens fragmentation, anterior capsulotomy (with or without phacofragmentation), and corneal incisions.
The system features the company's Augmented Reality technology platform, which consists of high-resolution 3D imaging measurement technology that enables precise imaging and biometric measurements of the anterior segment eye anatomy, even for dense cataracts. The platform provides low-noise images from the anterior surface of the cornea to the posterior capsule of the crystalline lens, while correcting for lens tilt or centration during the customized treatment to accommodate each patient’s individual anatomy. It also enables creation of the precise capsulotomy incision size, shape, and location for effective intraocular lens (IOL) positioning and fitting for individual patients.
The system's phacofragmentation techniques enable removal of all grades of cataracts and reduce the need for ultrasound energy required in conventional cataract surgery. Furthermore, the entire procedure can take place in a single procedure room.
The company is currently selling the system to cataract surgeons in the US, Europe, and several other countries around the world.
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