Who regulates LASIK?

In the United States, the U.S. Food and Drug Administration (FDA) regulates the sale of all medical devices, including the lasers used for LASIK.

Before a medical device can be legally sold in the U.S., the person or company that wants to sell the device must seek approval from the FDA. To gain approval, they must present evidence that the device is reasonably safe and effective for a particular use (the indication).

Once the FDA has approved a medical device, a licensed doctor may decide to use that device for other indications if the doctor feels it is in the best interest of a patient. The use of an FDA-approved medical device for other than its approved indication is called "off-label use" or a "practice of medicine" use.

An example of an off-label (or practice of medicine) use would be if an eye surgeon uses a brand of laser for LASIK that has been approved by the FDA for another type of eye surgery (e.g. PRK) but not specifically for LASIK.

The FDA does not regulate off-label use of medical devices or the practice of medicine. It also does not have the authority to:

• Regulate a doctor's practice. The FDA does not tell doctors what to do when running their business or what they can or cannot tell their patients.
• Set the amount a doctor can charge for LASIK eye surgery.
• "Insist" that the doctor gives potential LASIK patients the patient information booklet prepared by the laser manufacturer.
• Recommend individual LASIK doctors, clinics or laser centers. The FDA does not maintain a list of LASIK surgeons.
• Provide ratings of lasers it has approved for LASIK surgery.

For more details on lasers that have received FDA approval for refractive surgery and the specific indications and treatment ranges for which they were approved, visit this FDA web page.

Editor's Note: There may be additional FDA-approved lasers that have not yet been listed on the FDA website.

Last updated: February, 2010