|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||LADARVISION 4000 AND LADAR6000 EXCIMER LASER SYSTEMS AND THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE|
|Classification Name||excimer laser system|
|Generic Name||ophthalmic excimer laser system|
|Supplement Type||real-time process|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a software change to the wavefront-image gathering sequence in the customcornea surgery planning software to allow for different pre-op and surgery days; a change to the ladar6000 software to allow for conventional centration photos to be imported from the ladarwave customcornea wavefront system; and, minor enhancements/bug fixes to the ladarvision 4000 software, the ladar6000 system software, and the customcornea surgery planning software.