Carl Zeiss Meditec (ETR:AFX) said today it won FDA premarket approval for its ReLEx Smile laser system intended for ophthalmological use.
The German company said that with the approval, its ReLEx Smile system is now cleared for patients with astigmatism. The approval also allows for a small entry incision to be made, allowing the company’s Smile procedure to be less disruptive to the corneal surface tissue.
“The expansion of Myopia treatment to patients with Astigmatism will enable current and future Smile surgeons to expand their patient base, paving the way for a new generation of refractive surgery patients,” ophthalmic devices global prez Jim Mazzo said in a prepared statement.
The ReLEx Smile uses a VisuMax femtosecond laser to create a lenticule inside the cornea and an access incision in the same step, Carl Zeiss said.
“Thanks to our continued collaboration with partner surgeons worldwide, we are able to pave the way for new developments and technologies in the refractive space. Now with the FDA approval for US Smile Astigmatism, we can now extend this great treatment option to US astigmatism patients as well,” prez & CEO Dr. Ludwin Monz said in a press release.
In August, Carl Zeiss Meditec said that it is acquiring cloud-based ophthalmological tech developer Veracity Innovations for an undisclosed amount.
