|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||VISX STAR S4 IR EXCIMER LASER SYSTEM AND WAVESCAN SYSTEM|
|Classification Name||excimer laser system|
|Generic Name||excimer laser for ophthalmic use|
|Supplement Type||real-time process|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an upgrade of the wavescan software to version 3. 67 to correct a design flaw that led to an incorrect patient treatment being delivered, and to introduce an additional software check to mitigate treatment calculation errors.