Aesthetic lasers continue to dominate the cosmetic industry since first taking a foothold in the early 1990s. There is a variety of lasers now available, giving providers the ability to help patients heal both physically and psychologically. Aesthetic laser procedures skyrocketed in popularity namely because they are almost always less invasive, cause minimal discomfort, and decrease recovery time.
In qualified hands, aesthetic lasers maintain a proven track record of safety and efficacy. However, the regulations surrounding physical lasers themselves as well as the industry as a whole are not nearly as straightforward.
How Are Aesthetic Lasers Regulated by the Federal Government?
Aesthetic Lasers are federally regulated as medical devices by the U.S. Food and Drug Administration (FDA). The FDA has granted approval to many aesthetic laser devices to treat the following:
But much confusion exists around how exactly aesthetic laser procedures are regulated in the United States. The FDA only regulates the manufacturers and physical medical laser devices; not the individuals administering the treatment.
Your practice must use FDA approved laser devices in order to operate legally. This is one of the primary reasons it takes new aesthetic laser systems such a long time to get to market. FDA approval ensures your providers and patients peace of mind alike, but it is also a lengthy process for a device with new, unproven technology to undergo. It is because of this many of the top cosmetic practices are now investing in a used, already FDA approved aesthetic laser systems.
How Are Aesthetic Lasers Regulated by States?
States regulate who is authorized to use aesthetic lasers, AND which specific procedures require certification. Laws and regulations governing laser devices are extremely inconsistent from state to state. Generally speaking, laser hair removal is significantly less regulated than more advanced aesthetic laser procedures.
Only licensed practitioners can purchase aesthetic laser equipment, however that doesn’t mean a licensed physician has to operate the device. In some states, all procedures must be performed by the physician themselves. But in many others, a licensed physician does not have to be physically present during a laser cosmetic procedure. Instead, the physician is somehow involved in their treatment through one of three ways:
- The physician, nurse practitioner, or physician assistant has examined the patient first,
- The physician is immediately available by telephone or other electronic means to respond to questions or emergencies, and, most importantly,
- The practitioner who is performing the treatment is trained, experienced, and qualified. But regardless of who’s performing the treatment, there should always be an RN on-site, at a minimum, to oversee the procedures.
Check with your state medical licensing board to determine who qualifies as a licensed practitioner in your state.
How do Aesthetic Laser Regulations Vary from State to State?
Each state is individual responsible for determining who is legally qualified to perform an aesthetic laser procedure. State medical boards issue certifications and are responsible for enforcement.
Arizona was the first state to pass legislature regulating laser hair removal, leading the way for other states across the country to begin to regulate laser use in the cosmetic industry. Since then, state regulations have progressed in many different, sometimes opposite directions.
Since 2005, 35 states have implemented laws that classify laser hair removal as a practice of medicine. Only 26 of those states require on-site medical supervision when NPOs perform the procedure. Sometimes, this means direct supervision, while in other cases, the medical practitioner does not have to be on site.
Perhaps the most liberal in regard to regulations, in New York, procedures like laser hair removal are entirely unregulated, and can have irreparable long-term effects. Georgia and Texas hold the middle ground, allowing non-medical professionals like estheticians or master cosmetologists to earn certification as a laser practitioner, but only after completing extensive training.
New Jersey has some of the strictest regulations in the country — limiting the practice of aesthetic laser use to medical professionals only.
The American Med Spa Association (AmSpa) is taking aggressive steps to combat the inconsistencies in state regulations by providing experts and professionals with educational resources and training opportunities.
AmSpa assures patients most med spa professionals and practitioners are, “operating in good faith, and with their patients’ best interests at heart.”
The rapid growth of aesthetic laser use in the cosmetic laser industry has brought many positive advances. AmSpa cites the quick rate of growth as the largest factor regulatory inconsistency. As a consequence, a small number of unqualified practitioners have entered the industry with the sole intent to profit, without following the applicable rules.
The industry earns credibility as a whole when cosmetic treatments are taken as seriously as traditional medical procedures, however the general public often does not think about cosmetic treatment safety in the same way.
“The public must recognize that medical spas are providing mostly medical treatment. Although some treatments at med spas are non-medical (facials, light chemical peels, light dermabrasions), most of the treatments are medical in nature and should be treated as such,”
“Patients should always be seen by a doctor, a nurse practitioner, or physician assistant, depending on their state. If a med spa offers to treat a patient without being seen by one of those three license-holders, red flags should go up and the patient should seek treatment elsewhere.”– AmSpa
Ultimately, the burden of safety falls upon the consumer – and med spa owners – to regulate themselves.
How to find if an aesthetic laser is FDA approved?
If you’re unsure wither your aesthetic laser is FDA approved, you can either check inside your laser’s product documentation or verify a specific laser’s approval directly through the FDA.
A good place to start is the paperwork that came with your aesthetic laser — the product manual will have all FDA approval information in addition to safety warnings and manufacturer contact information. If your paperwork is missing, most major aesthetic laser manufacturers like Alma, Candela Cynosure, DEKA and Lumenis all provide extensive product documentation on their websites.
If you’re still not having any luck, its best to go straight to the source, and check with the FDA. The FDA maintains the Establishment Registration & Device Listings Database, which includes all registered medical device manufacturers and medical devices approved by the FDA. To search, you’ll need the name of your device, model number, and manufacturer.
Remember, just because a device appears as a search result does not mean it is FDA approved — you must verify the record is current and your specific laser device has been granted appropriate approval.
Aesthetic Laser Safety Best Practices
Despite the industry’s best efforts to establish broad regulations and certification processes, any aesthetic laser procedures come with some amount of risk. Even the most qualified professionals using the highest grade technology can cause irreversible harm to a patient of safety basics are not in place.
Aesthetic laser procedures should only be carried out by a trained and qualified practitioner, but laser safety is everyone’s responsibility. It’s good idea to document safety practices and procedures with checklists to establish routines and keep everyone in sync. Be sure your procedures include the following:
- Patient education and expectation management
- Regular laser inspections and maintenance
- Room and equipment sanitization
- Eye protection
- Asking extra visitors to wait outside the room
- Visible and detailed warning signs
- Smoke evacuation systems
- Use of cooling gels or other patient comfort products
Laser Service Solutions: Your Trusted Authority
At Laser Service Solutions, we specialize in supplying high-quality pre-owned aesthetic laser systems and replacement components. We also pride ourselves on our reliable service technicians, who can repair, upgrade and inspect your equipment on site. Laser Service Solutions offers daily rental programs and affordable financing options on pre-owned aesthetic laser equipment. Chat with us online or call today at (856) 853-7555.