Government (FDA) Regulation of LASIK Surgery

The government (FDA) regulates LASIK to keep it safe and effective

As technology has evolved, use of lasers has increased rapidly in medical and surgical interventions. With respect to the "eye health and medicine", laser use has increased more than anything, and the demand has pushed the price of powerful laser procedures even lower. As the price goes down, more and more people are considering opting for laser surgery to remove their cataracts and improve their eyesight (a procedure specifically known as LASIK). This is naturally creating more opportunity for misuse and injury especially when, according to an estimate, approximately 700,000 eyes will receive refractive surgery with LASIK devices by the end of year 2011.

FDA's Authority - What the FDA can do?
Fortunately, the FDA regulates radiation-emitting electronic products, including all types of lasers (including those used in LASIK). The agency sets radiation safety product performance standards that must be met by manufacturers before laser products can be legally sold (and used) in the U.S. market. The FDA even further extends this authority to testing laser products and inspecting displays of laser light shows to ensure the public is protected.

In addition, the following points will help you understand the FDA's authority and its scope of regulations on laser-based procedures including LASIK:

The FDA's specific stance on LASIK
While it is true that the FDA does not have the authority of putting a ban on a specific kind of operation or surgery, the FDA can still impose certain conditions related with the use of the devices in any medical or surgical procedure including those practiced in the field of eye medicine and surgery. Under the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, the FDA has the authority to regulate all kinds of lasers including those used in medicine.

The Food and Drug Administration (FDA) recognizes four major hazard classes (I to IV) of lasers, including three subclasses (IIa, IIIa, and IIIb). The higher the class, the more powerful is the laser and the potential to pose serious danger if used improperly.

The lasers which are used to perform LASIK eye surgery fall under FDA class IV and IEC (International Electro-technical Commission) class 4 that recognizes LASIK laser as a "device that may pose an immediate skin hazard and eye hazard from exposure to either the direct or reflected beam and may also present a fire hazard."

FDA also necessitates that the class designation, ranging from Class I to IIIa. Class IIIb and IV products should be used only by individuals with proper training and in applications where there is a legitimate need for these high-powered products.

While FDA has approved the lasers and tools used in the LASIK procedure in people 18 years and older with stable eyesight, it strictly advises to avoid LASIK during pregnancy and in those having eye diseases in the past.

It should also be noted that all the data related with LASIK use, surgery (use or abuse) and any post-surgical (after surgery) adverse or side effects fall under FDA jurisdiction under 21 CFR, Part 5.10.

In short, the Food and Drug Administration (FDA) is concerned about the increased market availability of all kinds of lasers and on the internet of certain types of laser products, some of which are being sold marketed illegally. In addition, FDA is also actively working to discourage online promotion of illegal lasers and online video testimonials that blatantly promote LASIK.

Learn more about the FDA's regulation of LASIK surgery on our forums!