LASIK, which stands for Laser-Assisted In Situ Keratomileusis, is a popular surgical procedure designed to reduce or eliminate the need for glasses or contact lenses. The procedure permanently reshapes the cornea, the clear front surface of the eye, using a highly specialized laser system. The technology and devices used to perform LASIK are approved by the U.S. Food and Drug Administration (FDA). The FDA’s approval process for these devices is extensive. This stringent oversight ensures that the lasers and diagnostic equipment used in the surgery meet high standards for both effectiveness and safety before they can be marketed to providers.
FDA Regulation of Medical Devices
The FDA regulates medical devices based on the level of risk they pose to the patient, categorizing them into three distinct classes. Class I devices present the lowest risk and are subject only to general controls, such as tongue depressors. Class II devices, which include items like powered wheelchairs, require general controls plus “special controls” to ensure their safety and effectiveness.
The excimer laser systems utilized in LASIK are classified as Class III medical devices, which represent the highest risk category. This classification is reserved for devices that support or sustain human life, are of substantial importance in preventing health impairment, or present a potential, unreasonable risk of illness or injury. Because of this high-risk designation, the manufacturers of LASIK lasers must undergo the most rigorous regulatory review pathway called Premarket Approval (PMA). The PMA process requires a company to submit extensive scientific evidence, including results from human clinical trials, to demonstrate the device’s safety and effectiveness.
The Specific Approval Status of LASIK Technology
The FDA does not approve the surgical procedure of LASIK itself, but rather the specific laser systems and associated technology used to perform the corneal reshaping. Each model of excimer laser, and often each software update or new intended use, must individually receive Premarket Approval (PMA). The initial PMA for an excimer laser system for use in the LASIK procedure to correct myopia (nearsightedness) was granted in 1998.
Subsequent PMA applications have expanded the approved uses of various laser platforms to include the correction of hyperopia (farsightedness) and astigmatism. The FDA’s approval is tied directly to the clinical trial data that demonstrated the device’s ability to safely and effectively correct vision within those parameters. Today, numerous different excimer and femtosecond laser platforms from various manufacturers have received PMA, each with its own set of indications and limitations. Patients can confirm that the specific laser their surgeon intends to use has been cleared through the FDA’s thorough, data-driven PMA process.
FDA Mandated Safety Information and Patient Criteria
The FDA requires that manufacturers and providers adhere to specific guidelines regarding patient selection and the disclosure of potential risks. A patient must satisfy certain pre-screening criteria to be considered a suitable candidate for the procedure. These criteria include having a stable vision prescription for at least one year and being a minimum of 18 years old.
Patients with certain systemic or ocular health conditions are often considered poor candidates, and the FDA requires disclosure of these contraindications. These include conditions like uncontrolled diabetes, autoimmune disorders such as lupus or rheumatoid arthritis, and certain eye diseases like keratoconus.
Furthermore, the FDA mandates that patients be fully informed of the risks and potential side effects associated with the procedure. Common risks that must be disclosed include developing dry eyes, experiencing visual symptoms like glare, halos, or starbursts, and, in rare instances, a permanent loss of best-corrected vision.