Are Epi-LASIK and LASIK FDA approved?
Laser Vision Correction has been approved by the FDA. PRK was the first to be approved. Epi-LASIK is an advanced form of PRK and the EPIVISION Keratome is approved for use in the United States. Most recent FDA trials have been done with LASIK. With some lasers and treatment modalities PRK and Epi-LASIK were not studied but are commonly done “off-label.” This means they were not formally tested by the FDA but must be done under physician discretion. In all cases where we do Epi-LASIK and custom ablation there is significant data to indicate this “off-label” use is safe and the procedures are effective procedures.
