LASIK was originally performed internationally in 1989 before being introduced to LASIK Surgeons in the United States in 1990.  LASIK was subjected to Food and Drug Administration clinical trials to prove its safety, efficacy and predictability in the early 1990’s before being approved in 1998 from the data provided as part of a Pre-market Approval Application (PMA).  Patients need to be aware of the two processes leading to FDA approval.  The PMA approval process is thorough, lengthy and demonstrates how a device or procedure will perform with regards to safety and efficacy in the real world. There is another route available call the 510(k) Approval that requires the manufacturer to provide only a limited amount of safety data to receive approval.