Interventional, prospective, longitudinal (follow-up: 30 ± 10 days), single-arm, single center, open trial. The first-in-man character of this investigation relies on the ergonomics of CATSYS (handpiece), and not on the laser technique, which is similar to other FLACS.~The purpose of the clinical investigation is to document the compliance of the investigational medical device with the general requirements of performance, safety and clinical benefit, in order to complete existing data and obtaining CE-mark for CATSYS.
This study is a Pre-market first-in-man clinical investigation to validate performance of a hand-held femtosecond laser named CATSYS.