Lasers: What Does FDA-Approval Mean?

If you’ve been doing any laser research recently, then you’ve probably come across the term “FDA-approved”. We hear this phrase over and over in our industry as it is meant to give credibility to the latest and greatest cosmetic laser technology. But, what does the term really mean? How does it impact your decision to have a certain treatment or procedure? Or should it?

First let us inform you that almost every laser manufacturing company and every laser practitioner that uses the device will tell you that it is “FDA-approved”. This tells you that the device has met certain requirements of the FDA—the United States Food and Drug Administration. It does not tell you, however, how effective the device is at treating a particular condition.

What are the requirements of the FDA for approval? They can vary, but for the most part, for a laser, the manufacturer must submit an application to the FDA stating that they intend to market the device to treat a certain condition. They also must submit one or more clinical trials done where the laser proves safe and effective in treating the skin condition indicated in the study. Only after these requirements have been met will the FDA approve a device.

So, what’s the issue? Well, the FDA-approval process has a couple inherently large flaws. First, the physicians who perform the clinical trials for the devices are generally compensated to do so by the device’s manufacturing company. They often get to use the device for free, and as a result, they are naturally biased to demonstrate positive results. This problem isn’t just in the medical device industry…it happens in all areas of medicine. Anything that needs approval by the FDA, including medications and vaccines.

The second problem is that approval is more reliant upon device safety than treatment efficacy. Take this example: if a clinical trial for a laser demonstrates that only one out of 10 people treated with it showed improvement and none of the 10 had any side effect or harm from the device, then that may still pass FDA standards. This means that the manufacturer could advertise the device as being “effective” for the condition, even though the rates of success in the clinical trials were very low. Unfortunately for consumers, the FDA looks more closely at safety than it does at efficacy.

This brings us to our final point: FDA-approved is a misnomer. The FDA simply grants “clearance” to a device. Clearance to the manufacturer to market it and sell it for use on the public. The FDA doesn’t even recognize the term “FDA-approved” because it implies that it approves of the use of a device for a particular condition. Nothing could be further from the truth. Instead of advocating for the use of the device for a condition, the FDA simply allows it to be used. Advocating and allowing are two very different things, and patients need to understand the difference when considering a treatment with an “FDA-approved” device.

No matter the semantics, the term “FDA-approved” is widely used and accepted by most laser practitioners and patients. It is important, though, to understand what that term really means. It is more of an indication of the safety of a device rather than its efficacy.

This is where consumer research and education become so important. You simply can’t rely on advertising to tell you if something works or not. You need to ask questions, be informed and learn all you can about your condition and the device that you are considering for treatment.

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