FDA Cleared LED Face Masks: The Verified 2026 List

FDA cleared LED face masks are at-home light therapy devices that have received premarket clearance from the United States Food and Drug Administration through the 510(k) pathway. As of 24 August 2026, the FDA’s 510(k) database lists 46 such clearances for LED light therapy devices. Roughly one third are held under a recognisable consumer brand name; the remainder are registered to contract manufacturers, predominantly in southern China, whose products reach consumers under a variety of other brand names.

The distinction between clearance, approval and registration is a frequent source of confusion in the consumer market for these devices, and the three terms are often used interchangeably in marketing material despite carrying different regulatory meanings. This article lists the devices on record, sets out the terminology, and describes the procedure by which any individual device may be verified against the FDA database.

Terminology

Three regulatory terms appear in marketing material for LED face masks. They are not equivalent, and only one of them applies to this device category.

The FDA has stated that registration and listing do not denote approval or clearance of a firm or its devices, and that firms may not use registration to imply endorsement.^[1]

Regulatory classification

LED face masks intended for cosmetic use are generally regulated as Class II devices, the middle of the FDA’s three risk-based classes. Class II devices are subject to general controls together with special controls, and most require a 510(k) premarket notification before they may be marketed.^[2]

Clearance is granted on the basis of substantial equivalence to a predicate device already on the market, rather than on independent clinical evidence of efficacy. A device may therefore be cleared without any trial having been conducted on that specific product.

List of FDA cleared LED face masks

The following table lists all 46 clearances returned by the FDA 510(k) database for the device name “led light therapy”, ordered by decision date, most recent first. Each clearance number links to the corresponding official record. Devices are marked as consumer brands where the cleared device name includes a brand sold directly to the public, and as OEM where the clearance is held under a manufacturer’s name only.

Market structure

Growth in clearances

Clearances for LED light therapy devices have increased sharply. Of the 46 records on file, 27 — approximately 59 per cent — were issued during 2025 and 2026. By comparison, the six years from 2016 to 2021 produced seven clearances in total.

Original equipment manufacturing

The majority of clearances are held by contract manufacturers rather than by the brands under which the devices are ultimately sold. Applicants of record include Shenzhen Chuangtong Yigou Technology, Guangdong Newdermo Biotech, Dongguan Miqiang Technology, Shenzhen Rainbow Technology and Shenzhen Desida Technology, among others.

Individual clearances frequently cover multiple model numbers. One clearance issued in July 2026 lists 17 distinct models; another lists ten. A single 510(k) may therefore cover an entire product family that is subsequently distributed under a number of different brand names.

A practical consequence is that a brand may be selling a device that is genuinely covered by a clearance while the brand’s own name does not appear anywhere in the database. Absence from the list of FDA cleared LED face masks is not, by itself, evidence that a device is uncleared.

Changes in manufacturing relationships

Manufacturing arrangements are not fixed. CurrentBody holds two clearances filed by different applicants: K250966, filed by Shenzhen Kaiyan Medical Equipment in June 2025, and K260715, filed by The Beauty Tech Group in June 2026. Duplex International Trading Limited appears twice, once in 2022 for a branded Project E Beauty device and once in 2026 for an unbranded model.

Among applicants, Led Technologies Inc., which markets devices under the reVive Light Therapy name, holds four clearances issued between 2018 and 2022. Guangdong Newdermo Biotech also holds four, issued between 2023 and 2026.

Verification procedure

Any device may be checked against the FDA database directly. The database is publicly accessible and requires no account.^[3]

1. Access the database. The 510(k) Premarket Notification search form is hosted on the FDA’s accessdata subdomain.
2. Complete a single field per search. The form combines fields with Boolean AND logic. Entering a brand in the Applicant Name field and a description in the Device Name field simultaneously will return no records even where the device is cleared.



3. Search the brand name. Records returned confirm a clearance held under that name. A nil return is not conclusive, for the reasons described under Market structure.



4. Locate a clearance number. Manufacturers that hold a clearance generally publish the corresponding K-number on the product page, in the manual, or on packaging. Searching a brand’s website for the string “510(k)” is more reliable than searching for “FDA”, which frequently appears in less specific claims.
5. Verify the clearance number. Entering the K-number in the 510(k) Number field returns the full record, including the list of model numbers covered. The model in question should appear among them.



6. Cross-reference the model code. Many devices carry a model code such as FM-03 or MK-110D printed on the housing or in documentation. Searching that code against the records above will in many cases identify the manufacturer.

Where a manufacturer declines to identify which clearance covers a device, the claim cannot be independently verified, irrespective of whether a clearance exists.

Limitations of clearance

A 510(k) clearance establishes substantial equivalence to a predicate device. It does not constitute a finding that a device produces a particular cosmetic result, nor does it specify the optical output of the device.

The biological effect of low-level light therapy is generally described in terms of delivered dose, expressed in joules per square centimetre, which is a function of irradiance and exposure time:

Dose (J/cm²) = Irradiance (mW/cm²) × Time (s) ÷ 1000

Because dose depends on irradiance, a stated treatment duration carries limited meaning in the absence of a published irradiance figure. Two devices emitting the same wavelengths for the same duration may deliver substantially different doses. Irradiance is not a required disclosure under the 510(k) pathway, and practice varies: some manufacturers publish measured values at a stated distance, while others publish none.

Wavelengths and claims

Consumer devices commonly advertise between three and seven light modes. The wavelengths with the most extensive published research are red and blue.

Two categories of specification claim warrant particular attention. Modes described as “purple” or “cyan” are typically produced by illuminating two sets of diodes simultaneously rather than by a distinct emitter, so a single nanometre figure quoted for such a mode does not correspond to a physical wavelength.

Claims regarding penetration depth are also frequently overstated. Visible red light penetrates human skin on the order of one to three millimetres, with near-infrared reaching somewhat further. Depth figures quoted in inches are not physically consistent with the behaviour of light at these wavelengths.

Common questions

References

1. U.S. Food and Drug Administration. Device Registration and Listing.
2. U.S. Food and Drug Administration. Premarket Notification 510(k).
3. U.S. Food and Drug Administration. 510(k) Premarket Notification Database. Retrieved 24 August 2026.

Method. Records were retrieved from the FDA 510(k) Premarket Notification Database on 24 August 2026 by searching the Device Name field for the string “led light therapy”, returning 46 results. Device categories overlap and some light-therapy products are cleared under other device names; the list is therefore not an exhaustive index of every light-emitting device marketed for facial use.