How LED masks blur the lines between cosmetic and medical claims

Social media is full of influencers showcasing the benefits of LED masks, but regulators are cracking down on unsubstantiated medical claims. Save Face explores the science and what aesthetic practitioners need to know.

Public engagement and demand for light-based therapies, driven by social media influencers, celebrities, and K-Beauty trends for at-home LED mask devices, have grown rapidly in recent years. People have become more curious about non-invasive skin tools that promise anti-ageing rejuvenation, acne banishment, or a way to get that ‘glow’ while sitting on their own sofa and watching TV.

The marketplace for LED light face masks was said to be worth $360.2 million in 2024, with a compound annual growth rate of 13.5% by 2030, putting it at $769.4 million in five years.[i]

Developments have led to a multitude of portable, solid, flexible, wireless, wearable LED masks now flooding the market. The downside is that many of the devices touted on the likes of TikTok and Instagram lack efficacy and do not live up to the often-misplaced claims they or their affiliates make to the public. Technology and manufacturing vary considerably, clinical evidence is poor, and regulatory scrutiny is, at best, limited.

LED Phototherapy exposes the skin to a combination of red, blue, and infrared therapeutic light wavelengths, measured in nanometers (nm) and emitted by high-powered light-emitting diodes. The process initiates light absorption and causes changes at a cellular level – a process known as photobiomodulation - including the biological stimulation of mitochondria and collagen production, and improvements in microcirculation. It is a well-studied treatment, targeted professionally at indications for skin rejuvenation, acne, wound healing, and other inflammatory skin concerns, including rosacea.

• Blue light (400-495 nm) targets cutibacterium acnes bacteria on the skin’s surface to reduce active acne breakouts.
• Red light (630-680 nm) penetrates the dermis for skin rejuvenation, stimulating collagen, reducing inflammation, and triggering cellular repair and healing to target sun damage and fine lines.
• Near-infrared (800-850 nm) goes a little deeper, improving circulation, healing, and cellular repair for wounds and scars.

Regulated in the UK as Class IIa medical devices, many free-standing and table-top professional systems from brands including Omnilux and Dermalux are well-established within the aesthetic medical sector. Over the years, as also seen in the laser/IPL hair removal marketplace, innovators began to develop home-use devices based on their underlying technology. However, premium LED technology does not come cheap and high-spec home use devices can be a barrier for price-sensitive consumers; thus, many ‘budget-friendly’ inferior models have surfaced, often from countries with varying safety standards. These lack production quality, use lower strength LEDs, incorrect wavelengths, or a low density of LED bulbs across the head/handset, which cannot deliver enough therapeutic light compared to the power of professional systems. In a largely unregulated space, counterfeiting and electrical safety are also concerns with these devices.

There is now a seemingly endless array of LED masks available – take a quick look at ecommerce platforms and marketplaces like Amazon and eBay to see just how many are out there – with prices varying from as little as £15 to well over £1,000. And this is inherently part of the problem.

In November 2025, the Advertising Standards Authority (ASA) adjudicated against several adverts that had been placed using paid advertising on Meta platforms (Instagram, Facebook, Threads, etc.) to showcase and sell LED masks directly to the public. The highlighted adverts, one of which was based around a user testimonial video, mentioned that their LED masks could be used to “…heal acne”, “…fight the signs of rosacea”[ii], “…tackle acne”[iii], “…provide targeted solutions for…acne, rosacea”[iv], or “… targeted treatment to effectively reduce acne-related redness”[v].

In all cases, the ASA banned the adverts for making medicinal claims when the products did not have applicable conformity markings (CE/UKCTA) or registration with the MHRA as medical devices. Therefore, no medical claims could be made for the products, whether or not such claims appeared in customer testimonials. The ASA has a remit to protect the public from unsubstantiated and misleading promotions. This activity formed part of a wider investigation into LED facemasks for skincare that make medicinal claims, with adverts identified using intelligence gathered by their Active Ad Monitoring system, which uses AI to proactively search for online ads that might break the rules.

Currently, there are no LED masks that comply with such conformity regulations and are registered as medical devices with the MHRA; therefore, at best, they can only make cosmetic claims that do not mention diagnosable medical conditions, like acne or rosacea.[vi] Establishing the safety and efficacy of at-home LED masks for medical device conformity would involve lengthy and substantial-scale controlled trials, which, invariably, are not commercially practical for direct-to-consumer product manufacturers and vendors, especially at the lower end of the market; thus, robust clinical evidence required for medical device conformity is sadly absent in home-use devices.

The public is somewhat ignorant of such rules, and it’s easy to understand why, amongst all the social media hype and affiliate marketing, which blur the lines between medical and cosmetic claims and efficacy, they believe the promises and want a deal. Home-use LED masks emit much lower energy levels, using cheaper components, compared to professional devices; thus, observable results tend to be inconsistent, slow to deliver, and modest or subtle at best. We suspect that many consumers are ultimately disappointed with their ‘viral’ purchase and leave it languishing in a drawer when it doesn’t deliver.

As medical aesthetic practitioners and healthcare professionals, this is a timely opportunity to educate your patients about the differences between medical-grade LED devices and cheap online deals for LED masks. The important observation is that the ASA ruling is not denouncing LED phototherapy as a treatment modality; their reprimand relates only to cosmetic, home-use devices making medical claims that they cannot substantiate, and is not against professional, medical device-certified systems where medical claims can be substantiated, clinically proven, and evidenced to patients.

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