05/07/2025
The AEA recently reconfirmed information about the permanence of electrology treatments with the FDA. This is a recent newsletter members received from the AEA:
FDA Reaffirms Electrolysis as Only Permanent Hair Removal Method
Laser hair removal devices remain cleared only for "permanent reduction," while electrolysis retains its FDA-recognized status as the sole method of permanent hair removal
The American Electrology Association is happy to announce that, after thorough inquiry and official correspondence, the U.S. Food and Drug Administration (FDA) has reaffirmed electrolysis as the only method of permanent hair removal recognized by the agency. This clarification provides reassurance to electrology professionals and clients that electrolysis’s designation as a permanent solution remains unchanged and exclusive.
Recent concerns arose when a long-standing statement about electrolysis’s status appeared to be missing from the FDA website. In response to AEA’s inquiries, the FDA’s Center for Devices and Radiological Health (CDRH) provided clear confirmation that the agency’s position is unchanged: electrolysis is still the sole technique officially acknowledged for permanent hair removal. By contrast, laser-based hair removal technologies continue to be regarded as providing only long-term hair reduction rather than permanent removal.
In its communication with the AEA, the FDA outlined how hair removal devices are regulated and categorized under federal law. Even though hair removal technologies are now grouped under broader medical device categories, the FDA drew a firm distinction between electrolysis devices and laser devices. Key points from the FDA’s overview include:
Regulating Body: The FDA’s CDRH oversees all medical devices, including hair removal technologies. Hair removal devices are classified under broader device regulations (e.g., 21 CFR 878.4810, which covers laser surgical instruments for use in general and plastic surgery and dermatology).
Laser Hair Removal Devices: Considered Class II medical devices, laser-based hair removal systems must undergo FDA 510(k) premarket clearance to ensure safety and effectiveness. These devices are FDA-cleared for “permanent hair reduction” – meaning they can significantly reduce hair growth long-term, but not permanently remove all hair. They are not recognized as permanent hair removal methods.
Electrolysis Devices: Typically falling under Class I (lowest risk) medical devices, electrolysis equipment is subject to general controls and usually exempt from premarket approval due to its established safety profile. The FDA recognizes electrolysis as the only method achieving permanent hair removal. In regulatory language, electrolysis is uniquely acknowledged for fully destroying hair growth cells, offering truly permanent results.
Key Distinction: Laser = Permanent hair reduction; Electrolysis = Permanent hair removal. This fundamental difference in terminology is maintained in FDA approvals and marketing clearances. Consumers should understand that while laser treatments can greatly diminish hair regrowth, electrolysis is the definitive solution when the goal is 100% permanent removal of hair.
Continued Oversight: The FDA continues to regulate the marketing, labeling, and safety claims of all hair removal devices. Even as laser and electrolysis devices are classified under broader categories, manufacturers cannot advertise lasers as “permanent removal.” Any device claiming permanent hair removal must meet the electrolysis standard. The FDA’s oversight ensures that the advertised outcomes (reduction vs. removal) remain truthful and substantiated by science.
This FDA reaffirmation of electrolysis’s unique status is a significant validation for the electrology profession. It underscores that, amid various hair removal options in the market, electrolysis stands apart as the only technique with officially recognized permanent results. Electrology practitioners can confidently reassure clients that when the FDA speaks of permanent hair removal, it refers exclusively to electrolysis. Likewise, consumers seeking truly permanent elimination of unwanted hair can look to electrolysis as the proven and endorsed method, while understanding that “laser hair removal” is effective for long-term reduction but not total permanence.
In closing, the American Electrology Association wishes to acknowledge the contributions of Randa L. Thurman, L.E., CPE, AEA’s 3rd Vice President and Membership Chair. Ms. Thurman’s dedication and many hours of research, phone calls, and liaison with FDA officials were instrumental in securing this important clarification. The AEA extends its sincere gratitude for her leadership and persistence, which have helped reassure an entire industry that electrolysis remains, as ever, the only permanent hair removal method recognized by the FDA.
