FDA > CDRH > LASIK > FDA's Role

FDA's Role

• What’s New
• FDA’s Authority
• FDA-Approved Lasers for LASIK

What's New

• Latest on FDA’s LASIK Program

FDA’s Authority

FDA regulates the sale of medical devices in the U.S. and monitors the safety of all regulated medical devices.

In the U.S., FDA regulates the sale of medical devices such as 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 FDA does not have the authority to:

• Regulate a doctor's practice.  In other words, 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" the patient information booklet from the laser manufacturer be provided to the potential patient.
• Make recommendations for individual doctors, clinics, or eye centers.  FDA does not maintain nor have access to any such list of doctors performing LASIK eye surgery.
• Conduct or provide a rating system on any medical device it regulates.

FDA monitors the ongoing safety and efficacy of all regulated marketed devices, through these problem reporting programs:

• MedWatch, the FDA Safety Information and Adverse Event Reporting Program. MedWatch allows reporting of serious problems related with drugs and medical devices from:
  • Manufacturers
  • Health care professionals and Consumers
• SightNet is a program through which health care professionals at participating facilities can share concerns about potential safety issues with ophthalmic medical devices, and report problems to FDA.

FDA-Approved Lasers for LASIK

For details on which lasers have received FDA approval, search our list of FDA-approved lasers for LASIK. This list provides you:

• specific treatment ranges for each laser
• phone numbers and addresses of medical device companies
• patient information and instructions for use
• changes to devices since they were approved

This list does not include FDA cleared laser keratomes.

Please note that new listings are not added until approximately five working days after the last day of the month in which the device was approved. In some cases, it can take as long as five weeks to appear.

Updated September 17, 2008

(Some Photos Copyright © 2000, Photodisc, Inc.)