There are several manufacturers from China who are now promoting their aesthetic devices on the internet and Ebay.  While it is tempting to try these devices out and buy them due to their inexpensive price tag, the vast majority of this equipment is not FDA approved.   Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires that all medical device manufacturers must register to notify FDA, at least 90 days in advance, of their intent to market a medical device.  Most foreign manufacturers have not done this.  Is is therefore illegal to use these devices in the United States.

It is extremely risky to be using any equipment that is not FDA approved.  It is very important to use only FDA approved devices and substances.  If anything were to go wrong during the treatment, the fact that a patient was given an FDA approved treatment limits your clinic’s liability dramatically.  In addition, you could be prosecuted by the FDA which is something don’t want to have happen.

As long as you follow the guidelines for use with those FDA approved aesthetic devices, you are on very safe ground.  A large portion of the liability is shared by the manufacturer, and most plaintiff’s go after the entities with the deepest pockets, which are typically the manufacturers.  If you are using a medical device that does not have FDA approval, you are on very shaky ground and if trouble arises, you could be the one left “holding the bag.”

Vin Wells, MHSA
www.RockBottomLasers.com
800-794-1097