Laser vision correction eye surgery was approved in the form of PRK in 1995 by the FDA.
A patient from Santa Barbara recently asked me a question I often am asked: how long has laser eye surgery been approved by the FDA?
Laser vision correction was first approved by the FDA in 1995, but only in the form of PRK, or “flapless” LASIK. LASIK began being performed in relatively large numbers in 1997, but only as an “off-label” version of PRK. “Off-label” means using a device or a medicine in a way which is technically different from the wording on the approval paperwork of the FDA. The excimer lasers of that time were approved to apply their laser beam directly to the eye in the form of PRK. LASIK involved making a flap before applying the laser.
I personally was involved in the clinical trials which brought LASIK “on-label”, meaning that the FDA wording was expanded to specifically include LASIK. This occurred in 2000.
Since the time PRK and LASIK have been approved by the FDA, it is estimated that well over 17 million cases have been performed in the United States alone, more worldwide. Both procedures have undergone stunning evolution from conventional surgery to the most modern forms of customized wavefront LASIK and customized wavefront PRK. Today, these procedures truly are in a mature state of refinement and development.
See Also
FDA Approved Lasers for PRK
FDA approved lasers for PRK laser vision correction.
FDA Approved Lasers for LASIK
A list of FDA approved lasers for LASIK laser eye surgery.
PRK Laser Eye Surgery: What is PRK and How Does it Differ From LASIK?
All About Vision summary of PRK and its differences from LASIK.
FDA Approves Excimer Laser PRK
News article from 1995 about the original FDA approval of PRK laser eye surgery.
Your Questions on LASIK Eye Surgery
NPR webpage discussion of LASIK.
LASIK
FDA LASIK page