FDA does not regulate the LASIK Medical practice. FDA approves the safety and effectiveness of Excimer Laser and other devices independent of any other product.
FDA does not regulate the LASIK Medical practice. FDA approves the safety and effectiveness of Excimer Laser and other devices independent of any other product.
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.
Make recommendations for individual doctors, practice or eye centers. FDA doesn't maintain or have access to any such list of doctors performing LASIK eye surgery.
Conduct or provide a ranting system on any medical device it regulates.
Today, most doctors say that complications in LASIK surgery occur in no more than 5% of the cases, but they are guided base on a report that the FDA show back in 2006. The true is, that up today the rate of LASIK complications are unknown by the FDA, but all these complains are been increasing in the last 2 years. Most common complains are dry eye, loss vision quality, double vision, glare, swelling, blindness among other..
We strongly believe that loss of vision quality is the result of an inappropriate Laser calibration.
Laser calibration can be measured with a device called a Lensometer, so let's take a moment here and take a look at this video for a better understanding.
As you can see, if the LASIK surgery is performed with the first calibration, as we show in the video, is very certain that will be some aberrations after LASIK surgery, because the lensometer doesn't show a sharp image as a result.
The blue Laser that is coming out of the EXCIMER Laser machine, is the result of an algorithm that controls the combination of gas (Premix, Nitrogen, Helium) and electricity. The result of the combination can treat the cornea very accurately, as long as the Laser is accurate as well. Click here Excimer Laser details...
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