The U.S. Food and Drug Administraton (FDA) has now given 510(k) clearance to LensAR (Orlando, FL) for its LensAR Laser System for lens fragmentation during cataract surgery. The system earned FDA clearance for anterior capsulotomy in May 2010. The system uses proprietary 3-D confocal structured illumination imaging and biometry technology, which images and analyzes the anatomy across all grades of cataract to improve proficiency, according to the company.
And Carl Zeiss Meditec (Dublin, CA) has secured premarket approval for its MEL 80 excimer laser for the treatment of hyperopia. This new indication complements the existing FDA-approved applications of the surgical laser for myopia and astigmatism.
The FDA has also approved the GenesisPlus laser by Cutera Inc. (Brisbane, CA) for treatment of fungal nail infections without the risk of serious side effects. Such infections often cause toenails to become discolored, thickened and separated from the nail bed.