|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|
|Classification Name||excimer laser system|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to the nidek ec-5000 excimer laser system (model cxii) including a reduction in size, the standardization of previously optional features, incorporating the control computer into the computer (previously stand-alone) and replacing the original (manual magnification) microscope with a new model with motorized magnification control. The new device will be named the nidek ec-5000 excimer laser system model cxiii.