ANSI - Z80.11
Ophthalmics – Laser Systems for Corneal Reshaping
|Publication Date:||9 August 2012|
Scope and purpose
This standard applies to any laser system whose primary intended use is to alter the shape of the cornea through the removal of corneal tissue, resulting in the improvement of visual performance.
This standard addresses the vocabulary, performance requirements, labeling, and clinical investigations necessary for this type of device.