WaveLight earns FDA approval for further clinical studies

September 17, 2004

The U.S. FDA has granted WaveLight Laser Technologie AG, an investigational device exemption that allows the company, based in Erlangen, Germany, to conduct additional clinical studies in the United States for its Allegretto Wave excimer laser system.

The U.S. FDA has granted WaveLight Laser Technologie AG, an investigational device exemption that allows the company, based in Erlangen, Germany, to conduct additional clinical studies in the United States for its Allegretto Wave excimer laser system.

The added clinical studies, expected to begin in the fall of 2004, will expand substantially the range of treatments already approved in the United States, including the correction of mixed astigmatism and wavefront-guided LASIK.

"The FDA approval for the Allegretto Wave in October 2003 was a crucial step in our international expansion," said Max Reindl, founder and chief executive officer of WaveLight. "The upcoming studies will help to further expand the Allegretto Wave's treatment range and its international market success."