WINTER PARK, Fla., Nov. 2 -- LaserSight Inc. said its PMA supplement to increase the repetition rate of its LaserScan LSX microspot scanning system to 200 Hz for the LASIK treatment of myopia and myopic astigmatism was approved by the FDA. The PMA supplement was submitted to the FDA on Oct. 5 with a request for review on a 30-day real-time basis.
This approval is necessary for the launch of the LaserScan LSX, which is the only laser system approved in the US that combines a 200-Hz repetition rate, a microspot and the high resolution of optimized low-laser fluence.