|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||SVS APEX APEX EXIMER LASER WORKSTATION|
|Classification Name||excimer laser system|
|Applicant||SUMMIT TECHNOLOGY, INC.|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for discontinuing further follow-up and report of the <6. 0 mm subjects in accordance with the post approval requirements.