Energy-Based Medical Devices in Plastic Surgery: A Comparison of FDA Approved Indications to Advertised Claims

Abstract

Abstract Background Lasers and energy-based devices are commonly employed in aesthetic medicine. In the United States, the Food and Drug Administration (FDA) regulates lasers as medical devices, restricting marketing to approved indications and making off-label claims illegal. Despite this, no comprehensive analysis of off-label marketing prevalence exists. Objectives This study aims to compare the FDA-approved indications for two popular aesthetic lasers to their online advertising claims. Additionally, it seeks to educate aesthetic providers on the current regulatory restrictions surrounding off-label advertising. Methods FDA-approved indications for two lasers – Helium Plasma Dermal Resurfacing (HPDR) and 2940-nm Fractional Er:Yag – were obtained from the publicly available Establishment Registration & Device Listings Database. Online advertisements regarding the capabilities of each laser were collected from practice websites in the United States. Results Our analysis of 100 online claims for each laser revealed that more than half of the websites advertising helium plasma (n=59) and 44 websites advertising fractional lasers made at least one off-label claim. Both plastic surgeons and non-plastic surgeons made at least one off-label claim, with no statistically significant difference between the groups. Conclusions Despite FDA regulation of medical devices, online advertising regarding the indications and capabilities of popular medical lasers varies widely. Patients who seek information regarding aesthetic laser treatments may encounter inaccurate and differing claims for these treatments, potentially leading to false expectations and poor patient outcomes.