FDA Premarket ApprovaL for ReLEx SMILE expanding myopia treatment to patients with astigmatism.-Carl Zeiss Meditec

The Medical Technology business group of Zeiss announced the FDA Premarket Approval (PMA) for ReLEx SMILE PMA expanding myopia treatment to patients with astigmatism. 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.

Zeiss ReLEx SMILE utilizes the high-precision femtosecond laser VisuMax to create a lenticule inside the cornea and access incision in a single treatment step. Its outstanding cutting precision, exceptional speed and gentle treatment make it an ideal platform for advanced corneal surgery such as SMILE. Incisions are made through microscopic-photodisruptions of tissue, created by ultrashort pulses.

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