FDA center
Find information about the Food and Drug Administration, which gave permission for using laser system for LASIC and the list of authorities uncontrolled by FDA.
FDA center

In the United States the sale of medical devices, including the lasers used for LASIK, is controlled by the Food and Drug Administration (FDA). If a person or some company wants to sell a certain medical device in the U.S. legally, it does have to get the permission from the FDA. In order to obtain such approval, they must produce proofs or “indication” of the sufficient safeness and effectiveness for a particular use of this device. After a medical device was accepted by FDA, it is for doctor to decide the use of that device for other indications and if it is favorable for his patient. In case the approved device is used for other cases which weren’t approved by FDA, indication gets the name "off-label use” and automatically doesn’t govern by this administration.

The list of authorities uncontrolled by the FDA:

1. FDA is not in privilege to regulate doctor’s practice, namely how to manage their business or proscribe the way of treatment to their patients. 
2. Settle the price a doctor can ask for LASIK eye surgery.
3. “Demand “from the factory owner of laser the patient information booklet to be supplied with the potential patient.
4. FDA has not the right to make up recommendations for medical clinics, eye centers or doctors itself,   it is not in responsibility of FDA to look through the list of doctors who work with LASIK eye surgery.
5. Manage a gradating system on any medical device it controls.

 Excimer lasers were the first refractive laser systems endorsed by FDA and were destined to use in PRK to take treatment of myopia and later astigmatism. Notwithstanding, doctors began to use these lasers not only for PRK but also for LASIK, and to treat another refractive errors except myopia. During the last years LASIK became the main surgery which is used for treatment myopia in U.S. Not so long time ago, some laser manufacturers have got permission from FDA to use laser systems for LASIK to treat myopia, hyperopia and astigmatism and for PRK to treat hyperopia and astigmatism.

Clinical studies based on the FDA Center for Devices and Radiological Health data showed that about 5 % of patients continued to use glasses following PRK for distance, and up to 15 % had used glasses time after time while driving. Adding to that many patients experienced mild corneal haze following surgery as a part of the normal curing process. The haze coused slight or absolutely no effect on final vision, and could be recognised by doctor with a microscope only. Just a few of patients had glare and halos around lights, but these symptoms  decreased or absolutely  disappeared in most of them not less than in six months. 

However, for about 5 % of patients, best-corrected vision without corrective lenses was little worse after surgery than before. According to these finding, in May 1996 FDA and the Federal Trade Commission (which supervise advertising) sent a letter to the eye-care community with a warning that unrealistic advertising claims, such as "get rid of your eyeglasses," and ungrounded claims about success rates could be deceiving to buyers.