Zeiss Receives FDA Approval for Laser Eye Surgery Device
ZEISS has won FDA approval to introduce the VisuMax Small Incision Lenticule Extraction (SMILE) procedure to the U.S. market.
SMILE is a femtosecond laser-based vision correction procedure.
Approval was based on study results submitted to the FDA, and they showed positive outcomes for the 336 eyes treated at five investigational sites in the U.S.
The device is currently available in approximately 500 clinics in 61 countries around the world. — Cynthia Jessup