|Approval Order Statement |
Approval for software changes introduced in software version 4. 23a that affected the error message displays during the conditioning, energy verification, and treatment phases. The device, as modified, will be marketed under the trade name technolas t217z zyoptix laser system for personalized vision correction and is indicated for wavefront-guided laser assisted in-situ keratomileusis (lasik) treatments for the reduction or elimination of myopia with sphere up to -7. 00d and cylinder up to -3. 00d and mrse <=7. 50d at the spectacle plane.