By Brad Adatto, JD, Partner, ByrdAdatto
Laser laws in the medical spa industry aren’t always easy to find or understand, especially since they vary from state to state. Laser and radiofrequency devices have become profit leaders in many aesthetic practices due to results that some of these devices are able to deliver. However, with great technology comes greater regulation, as federal and state governments seek to protect the public from potential harm from misuse of this technology.
On the federal level, the Food and Drug Administration regulates medical lasers, as it does with other medical devices. [Click here for information on the FDA’s recent warning regarding energy-based vaginal rejuvenation devices.)
On the state level, a variety of regulations have been adopted, and the spectrum of regulations is massive. These rules can be confusing, as they can restrict everything from who can own the machine, to who can develop the treatment plan, to finally, who can actually fire the laser.
To make matters more confusing, some states have few, if any, laws directly addressing lasers. Instead these states have general laws on medical procedures or devices that indirectly control laser usage, and the laws are enforced by the medical boards.
As an example, Texas laws divide medical lasers into two categories. One category includes laser radiation and intense pulsed light devices. The other category covers laser or pulsed light hair removal devices. Each class is restricted as to who can own the lasers, where they can be used, who can use them, and what special or additional licenses or registrations are needed.
In Texas, intense pulsed light (“IPL”) devices can only be used in a medical clinic and under the supervision of a licensed medical doctor. The device must be registered with the Texas Department of State Health Services. Further, there are substantial restrictions as to who can perform the IPL services under the doctor’s supervision. Light-based hair removal devices in a medical practice are not required to be registered with the state, as the procedure doesn’t remove part of the epidermis. Further confusing the matter, a non-physician can get a Texas license to open a laser facility. But this license limits the light-based device types and their uses at the facility, and enacts additional supervision requirements.
Compare this to laser laws in Georgia, or California, and you can begin to see how requirements can vary drastically.
AmSpa members can check their medical aesthetic legal summary to see laser laws in their state.
The use of lasers in the aesthetic industry does not appear to be slowing down. Having a clear understanding of your state’s laser licensing and regulatory scheme is essential to avoiding legal pitfalls in your practice. For more information and guidance on your state’s laser regulation and oversight requirements please contact the law firm of ByrdAdatto.
Brad Adatto, JD, is a partner at ByrdAdatto, a business, healthcare, and aesthetic law firm that practices across the country. He has worked with physicians, physician groups, and other medical service providers in developing ambulatory surgical centers, in-office and freestanding ancillary service facilities, and other medical joint ventures. He regularly counsels clients with respect to federal and state health care regulations that impact investments, transactions, and contract terms, including Medicare fraud and abuse, anti-trust, anti-kickback, anti-referral, and private securities laws.