How does the FDA approve all the new technologies appearing in the aesthetics world? The process can seem complicated, but taking a look into its history makes it easier to understand.
FROM DANGER TO DEFENSE
In 1937, antibiotics were a new medical breakthrough. One of the most popular drugs at the time was sulfanilamide, used to treat bacterial infections and available in powder or tablet form. The S.E. Massengill Company decided to make a raspberry-flavored “elixir” version. To dissolve the drug, their chemist used diethylene glycol (DEG) – a chemical commonly used in antifreeze. No safety testing was performed, nor was it required by law at the time. The company distributed 240 gallons of this “elixir” across the United States. Soon after, reports of deaths – especially among children – began to surface. Patients suffered excruciating abdominal pain, vomiting, kidney failure, and ultimately death.
This tragedy shocked the nation. In response, Congress passed the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 1938. It gave the FDA the power to require safety testing for drugs and to regulate how they were manufactured and marketed. Over time, the FD&C Act was revised and expanded. One of the most important updates for aesthetics came with the Medical Device Amendments of 1976. This law created categories of medical devices based on risk: Class I, lowest risk; Class II, moderate risk; and Class III, highest risk.
The amendments also introduced two regulatory pathways: premarket approval (PMA) for new or high-risk devices that require extensive clinical data, and 510(k) clearance for devices that are “substantially equivalent” to one already on the market. This framework still governs how lasers, intense pulsed light (IPL), ultrasound, radiofrequency (RF), and other aesthetics devices are evaluated today.
FDA APPROVAL
Premarket Approval (PMA)
Premarket approval is required for Class III devices (highest risk) and necessary when no similar device exists on the market. It involves clinical trials, laboratory testing, and rigorous review to prove safety and effectiveness, often taking two years or more to complete. Once successful, the device is marketed as FDA-approved.
De Novo Classification
De Novo classification is used when a device is novel (no existing equivalent) but considered low-to-moderate risk. The manufacturer must provide evidence of safety and effectiveness. The FDA then creates a new device classification that future manufacturers can use as the basis for 510(k) clearance. Microneedling devices, for instance, initially went through the De Novo pathway.
510(k) Clearance
510(k) clearance is the most common pathway for Class II devices. This pathway requires manufacturers to demonstrate their device is substantially equivalent to an already cleared device. The FDA review typically takes about 90 days, with devices cleared through this process marketed as FDA-cleared, not FDA-approved. After a microneedling device received De Novo approval, subsequent microneedling devices entered the market through 510(k) clearance.
DEVICE CLASSES
Class I: Lowest Risk
Class I products present minimal potential for harm. They do not require FDA premarket review but must meet labeling, manufacturing, and registration requirements. Examples include jade rollers, comedone extractors, dermaplaning blades, ultrasonic skin spatulas, and high-frequency tools.
Class II: Moderate Risk
Class II products require special controls and, typically, 510(k) clearance. Their classification depends on how the manufacturer markets the device. For example, an LED panel marketed for wellness may be Class I, but if it is marketed to treat acne or reduce wrinkles, it becomes Class II. Some lower energy intense pulsed light systems, lasers, radiofrequency devices, microneedling with energy, and ultrasound-based devices are Class II.
Class III: Highest Risk
Class III products carry significant risks, including scarring, permanent injury, or worse if not properly used and require premarket approval to prove safety and effectiveness. Many high-powered energy devices fall into this category.
SAFETY IS PARAMOUNT
FDA classification matters. The FDA doesn’t just evaluate whether a device works – it ensures safety testing is performed. The FDA ensures aesthetics devices meet energy and performance standards as well as ensuring marketing claims from the manufacturer match the approved or cleared use. They also follow adverse events to ensure safety in the marketplace. This work protects both skin care professionals and clients, ensuring aesthetics treatments are based on sound evidence and regulatory oversight.
The FDA approval process for aesthetics devices may seem complex, but it’s built on decades of lessons learned – some of them tragic. From the sulfanilamide disaster in 1937 to today’s advanced lasers and microneedling systems, regulation has evolved to prioritize safety, effectiveness, and transparency.
For practitioners, understanding these classifications isn’t just about compliance; it’s about earning client trust. For clients, it’s reassurance that the tools being used in their treatment rooms are backed by scientific evidence and regulatory safeguards.
In short, the FDA process ensures that innovation in aesthetics continues to move forward responsibly, protecting both the industry and the public it serves.
A technician, educator, mento, and business owner, Mary Nielsen has been at the forefront of the developments in medical aesthetics since its infancy in the early 1990s. A nurse by training and experience, Mary was drawn into advanced medical aesthetics with the advent of laser technologies and their use while working for a plastic surgeon. She went on to found her own successful skin and laser clinic. She is the author of “A Compendium for Advanced Aesthetics, a Guide for the Master Esthetician.” four publications on medical spa policies and procedures, and safety policy and procedures. She is a contributor to “Milady Standard Esthetics: Fundamentals, Edition 12.” She is the executive director of Spectrum Advanced Aesthetics.
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