FORT WORTH, Texas, Sept. 26 /PRNewswire/ The Alcon Summit Autonomous LADARVision® System is the first to win approval from the U.S. Food and Drug Administration to treat farsightedness (hyperopia) (less than or equal to +6.0 D), with or without astigmatism (less than or equal to -6.0 D) and for mixed astigmatism, using the LASIK procedure. The approval, which was announced Friday, September 22, gives LADARVision® the broadest range of approvals of any FDA-approved excimer laser and makes it the only one capable of treating all types of refractive errors with LASIK. Additionally, the LADARVision® system is the only FDA-approved laser system to combine laser radar eye tracking with small scanning spot technology during surgery.
The FDA granted expedited review to the company's filing because it represents a first for LASIK's use in hyperopia, hyperopic astigmatism and mixed astigmatism. The LADARVision® System is currently the only FDA-approved laser system to achieve these indications in a single procedure, minimizing the amount of tissue removed and eliminating potential risk of misalignment possible in second procedures.
Founded in 1985 and acquired by Alcon in 2000, Summit Autonomous Inc. is a leading developer, manufacturer and marketer of ophthalmic laser systems and related products designed to correct common vision disorders such as nearsightedness, farsightedness and astigmatism. In 1995, Summit Autonomous was the first to receive FDA approval for an excimer laser system for the correction of mild to moderate myopia in the U.S., and in 1999 became the first commercial excimer laser manufacturer to receive FDA approval for the popular LASIK procedure.
Created September 29, 2000