|Trade Name||LASERVISION/VISX EXCIMER LASER FOR PRK AND PTK (MOBILEXCIMER)|
|Classification Name||excimer laser system|
|Applicant||LASER VISION CENTERS, INC.|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - indications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for two add'l indications, myopic astigmatic prk (prka) and high myopia with and without astigmatism for the device. The device, as modified, will be marketed under the trade name mobilexcimer(r) for ptk and prk. The mobilexcimer(r) for ptk and prk remains indicated for the indications listed in fda's letter of 4/27/97 (p960019/s001 and the new indications contained in this supplement.