The FEMTO LDV Z2, Z4, Z6 and Z8 are CE marked and FDA cleared. For some countries, availability may be restricted due to regulatory requirements; please contact Ziemer for details. Presbyopia treatments occur exclusively by a pocket creation and the implantation of a corresponding corneal inlay of a third party. Availability of related corneal inlays and implants may vary according to policy of the individual manufacturers and regulatory status in the individual countries. To comply with FDA regulations, devices for sale in the U. S. do not mention 'Presbyopia' on the panels.