FDA Approves Zeiss’ ReLEx SMILE

Zeiss’ medical technology segment has announced FDA premarket approval (PMA) for its ReLEx SMILE system, expanding myopia treatment to patients with astigmatism.

ReLEx SMILE utilizes the high-precision femtosecond laser VisuMax to create a lenticule inside the cornea and an access incision in a single treatment step. Incisions are made through microscopic photodisruptions of tissue created by ultrashort pulses. The PMA also provides for a small entry incision to be made, allowing the SMILE procedure to be potentially less disruptive to the corneal surface tissue.

The VisuMax laser is the first femtosecond laser to receive FDA PMA approval for the treatment of a refractive indication in addition to 510(k) clearances for LASIK flap, keratoplasty, and intrastromal corneal ring. With the approval of ReLEx SMILE, patients can now benefit from a minimally invasive surgery, performed on one laser versus two.

The ReLEx SMILE made its U.S. debut in 2016. In the last 10 years, more than 1.5 million SMILE treatments have been performed worldwide, constituting more than 10 percent of global laser vision correction procedures.