|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||NIDEK EC-5000 EXCIMER LASER SYSTEM|
|Classification Name||excimer laser system|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to replace the 60hz eyetracker with the 200 hz eyetracker in the nidek ec-5000 excimer laser system for the treatment of myopia and myopic astigmatism.