DevicePMAs@therightstef:P970053_S006 JSONTXT 11 Projects

Approval to modify the approved claim for the ec-5000 excimer laser system to allow for threatments using an optical zone size of 5.5 mm to 6.5 mm, in addition to the approved optical zone size of t. t mm, for lasik treatment of myopia and myopia with astigmatism. The device, as modified, will continue to be marketed under the trade name nidek ec-5000 excimer laser system and remains indicated for the reduction or elimination of -1.00 d to -14.00 d myopia spherical equivalent with or without <=-4 d astigmatism.