FDAnews
www.fdanews.com/articles/69346-visx-iris-registration-product-approved-by-the-fda

VISX Iris Registration Product Approved by the FDA

March 2, 2005

VISX has announced it received approval from the FDA to market and sell Iris Registration technology, the first fully automated method of aligning and registering wavefront corrections for CustomVue treatment.

Iris Registration is designed to replace the current means of registration, which involves manual marking of the eye to assess rotational movement. The technology enhances VISX CustomVue individualized laser vision correction, which enables physicians to measure and correct unique imperfections in each patient's vision.

Iris Registration is a hardware and software product enhancement that is a field installed upgrade to the VISX WaveScan and VISX STAR laser systems. VISX intends to begin U.S. shipment of Iris Registration in the second quarter.