123s of Laser Laws

Bradford E. Adatto | 7.23.18

 

brad_grid

1, 2, 3s of Laser Laws

No longer just the realm of Buck Rogers and Star Wars, lasers have become a common everyday technology.  Aesthetic medicine in particular has benefited greatly from adopting laser technology.  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. On the state level, a variety of regulations have been adopted, and the spectrum of regulations are massive.  These rules can be confusing, as it 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’s law laws divide medical lasers under 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..

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 Bradford Adatto at Badatto@byrdadatto.com or (214) 291-3201.