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Almost every laser company out there (and almost every dermatologist that uses lasers) advertises their lasers as “FDA Approved“. While FDA approval is certainly important (without it a company cannot market a laser), it is not the final word on whether or not a particular laser works well.

The FDA – the United States Food and Drug Administration – is the governing body in charge of regulating the use of lasers for the treatment of dematologic conditions. When a laser manufacturer applies to the FDA for approval to market a specific device for a specific application, they must submit the results of clinical tests performed on real patients. The FDA then approves or does not approve the marketing of the device.

There are several problems inherent in the FDA approval process. The first is that the term “FDA Approved” is a misnomer – it does not exist with the FDA. The FDA offers “clearance” of a device such that it can be marketed for a particular application. It does not offer “approval”. So while “FDA Approved” is the most commonly used industry term, it is not recognized by the FDA since they issue a “clearance” to market a device. The distinction between “approved” and “cleared” is important in that the FDA does not want to be responsible for giving consumers the impression that it approves of the use of the laser for the condition. Rather it will allow the manufacturer to market the laser, but is not advocating that it works well. This is a very important distinction.

The clearance offered by the FDA to market a laser is primarily based on the issue of safety rather than efficacy. The FDA clears a device in most cases if it has been shown to be safe for consumers AND if it can be shown that anyone in the trial received improvement. Most trials for dermatology lasers are based on a small (10-40) patient sample. If none of the patients are harmed in the trial and at least one can be shown to have received improvement for the condition being treated, it is possible to get FDA clearance to market the device. In this particular example, if only 1 in 10 patients responded well, most of the general public would agree that this is not a very worthwhile treatment. Nonetheless, in this situation, the manufacturer can receive FDA clearance to market the device for the particular condition.

In addition to the problems that exist with the FDA clearance process, the physicians that conduct the trials often have a conflict of interest. Physicians get paid to perform these trials and they also get to use the laser equipment for free, so there is an inherent desire to show positive results for the manufacturer. This conflict exists in all areas of medicine and is something that consumers need to take into consideration when they hear that a laser is “FDA Approved“.

We urge consumers to maintain a healthy dose of skepticism when evaluating and learning about any laser or cosmetic procedure. Consider going to multiple consultations, reading online reviews of the organization and procedures under consideration and remember that “FDA Approval” really means “FDA Clearance” and that the FDA is much more concerned with whether the laser is safe than if it works well for most patients.


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