|Approval Order Statement |
Approval for an expansion of +- 0. 75 d for the allowable target offset parameter range for the wavefront-guided myopic lasik indication. The device, as modified, will be marketed under the trade name ladarvision 4000 excimer laser system and is indicated for the reduction or elimination of myopia up to -7. 00 d with less than -0. 50 d of astigmatism at the spectacle plane.