|Trade Name||LADARVISION 4000 EXCIMER LASER SYSTEM|
|Classification Name||excimer laser system|
|Generic Name||ophthalmic excimer laser system|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the customcornea surgery planning software to be used with the ladarvision 4000 excimer laser system which will allow treatment planning by the practitioner prior to the actual date of surgery. 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.