13 September 2016 - The U.S. FDA today approved the VisuMax Femtosecond Laser for the small incision lenticule extraction (SMILE) procedure to reduce or eliminate nearsightedness in certain patients 22 years of age or older.

Not all patients are candidates for SMILE, and individuals should carefully review the patient labeling and discuss their expectations with their eye care professional.

“This approval expands the surgical treatment options available to patients for correcting nearsightedness,” said Malvina Eydelman, M.D., director of Ophthalmic and Ear, Nose and Throat Devices, in FDA’s Center for Devices and Radiological Health.

Read FDA press release