LED face masks: what an FDA clearance covers, and what UK ad rulings found about the claims

LED face masks shine red, near-infrared, blue or other colored light onto the skin. In the US, masks that the FDA has cleared for wrinkles or acne went through its 510(k) premarket notification process, and the number of clearances has jumped: by our count of the FDA's open data, which it labels unvalidated, the agency issued 42 clearances for over-the-counter light-based wrinkle devices in 2025, against 16 in 2024. In the UK, the advertising regulator has ruled against several mask ads over what they claimed.

Where LED masks sit in FDA rules

The FDA files light-based wrinkle devices for home use under product code OHS, "Light Based Over The Counter Wrinkle Reduction", a class II device type under regulation 21 CFR 878.4810. Home acne devices that use red and blue light have their own code under the same regulation, OLP, also class II, which the FDA defines as over-the-counter devices intended to treat mild to moderate acne vulgaris.

The FDA's open data service, last updated on November 2, 2026, lists 166 clearances under code OHS, the earliest in 2008. Not all of them are masks: going by their names, the list also includes devices for the eyes, lips and neck, and stand-alone therapy lights. openFDA says all of its results should be assumed to be unvalidated. The year-by-year totals below are our own count of those records.

What a clearance shows, and what it does not

A 510(k) clearance is a finding of substantial equivalence. In the clearance letters for both masks described below, the FDA says it found the device substantially equivalent to legally marketed predicate devices that do not require premarket approval, and that the company may therefore market it, subject to general controls such as registration, good manufacturing practice and labeling rules. Both letters add that device labeling must be truthful and not misleading.

The public summaries show what the companies submitted. The faceLITE mask, cleared on September 12, 2019, is indicated for the treatment of full-face wrinkles and was compared with an LG Beauty LED mask (K170984). Its summary lists non-clinical testing to electrical and medical device standards, including IEC 62471 for the photobiological safety of lamps, and a label comprehension study with 32 participants. On clinical data, the summary says none was required because the mask raised no new questions of safety and efficacy.

The CurrentBody Skin LED Multi Light Therapy Mask, model MK-110D, submitted by The Beauty Tech Group, was cleared on June 3, 2026; its clearance letter lists product codes OHS, OLP and ILY, the last for topical heating. Its summary lists four modes: one using yellow and near-infrared light for full-face wrinkles, one using blue and red light for mild to moderate inflammatory acne, one cleared for topical heating and temporary relief of minor muscle and joint pain, and a green mode the company describes as for comfort and relaxation only. Its indications for use say it is intended for Fitzpatrick skin types I to IV. The mask comes with eye inserts and passed IEC 62471 testing, and the summary states that clinical performance testing was not needed for this 510(k).

What the UK advertising regulator found

On June 10, 2026, the UK's Advertising Standards Authority (ASA) upheld a complaint about a Beauty Pie poster seen on the London Underground on December 17, 2025, which called the C-Wave Facial LED Treatment Mask "clinically proven to reduce wrinkles in 4 weeks".

Beauty Pie told the ASA that the mask was marketed only for cosmetic purposes and that the claim rested on two studies of the device and six peer-reviewed studies of what it called equivalent technology. The ASA found the two product-specific studies unpublished and methodologically limited: they had 28 and 20 participants, no control group and no blinding, and in the first, participants applied a hydrogel mask, not sold with the product, before each session. In the second, 65% of participants neither agreed nor disagreed that their fine lines looked less visible. The ASA said the studies of other devices, which differed in design, setting or schedule, were not adequate to substantiate a claim made specifically for this product. It concluded that the ad was misleading and told Beauty Pie not to repeat the claim without adequate substantiation.

The ruling refers to Beauty Pie's mask as the FaceLITE device, and Beauty Pie told the ASA that another company manufactures it. The FDA's database lists the 2019 faceLITE clearance described above, but neither record says whether the two are the same model, so we do not treat them as one.

Acne claims raise a separate issue in the UK. On November 5, 2025, the ASA ruled against a Meta ad and a web page from Invention Works BV, trading as Silk'n, that described LED mask treatment for acne and acne-related redness. The Medicines and Healthcare products Regulatory Agency (MHRA) told the ASA that, although it reviews products case by case, claims to treat redness related to acne were in general medicinal claims, and the ASA had seen no evidence that the mask was registered with the MHRA or had the appropriate conformity marking. Silk'n said it never used the word acne in its own communications, only when quoting customer reviews, as in the Meta ad, and understood "acne-related redness" not to be a medical claim. The ASA said the ruling was part of wider work on LED facemasks, and a December 2025 news item from the Committee of Advertising Practice (CAP), published on the ASA's website, also pointed to rulings involving Luyors Retail, Beautaholics and Project E Beauty.

The same news item said that a customer testimonial does not exempt a medical claim from the rules, and that even a registered device with the right marking still needs robust evidence for the claims made for it.

What the records leave open

In our reading, the records describe what a mask is cleared or allowed to claim, not how well a particular mask works for a particular person. Of the two FDA summaries reviewed here, one says clinical data is not required and the other that clinical performance testing was not needed for its 510(k), while the ASA's Beauty Pie ruling shows the kind of product-specific evidence it expects before an ad can say a mask is clinically proven. US clearances and UK rules also differ. The ASA's rulings tie medicinal claims to MHRA registration and the right conformity marking, so on our reading an FDA clearance for acne would not, by itself, allow a UK ad to claim that a mask treats acne.

How this guide was put together: we read the FDA's 510(k) records and summaries for the two masks named here, counted clearances in the FDA's open data, and read two ASA rulings and a CAP news item. We have not tested any mask and did not review the clinical literature on light therapy. Prices are not covered.