You'll often see "FDA approved" on LED masks. Most are actually cleared through the US 510(k) route, which means the FDA accepted that the device is similar to one already on the market. It's a US status, not UK approval, and for most masks it was based on bench testing rather than clinical trials, so it doesn't show that a mask works.
We checked each clearance number against the FDA's own database. Our labels guide explains UKCA, CE, MHRA registration and FDA clearance in full.
A 510(k) number for this mask (or its model family) that we found and read in the FDA database. Claims we couldn't match to an FDA record are listed separately.
Each mask shows the fact that put it here, with where that fact came from. Missing information is shown as missing. Background: FDA cleared, CE, UKCA: what labels mean.
FOREO
£503.30 checked 1 Nov 2026
FDA 510(k) K240378 (FAQ™ 201, FAQ™ 202; Foreo, Inc.; decision 19 Apr 2024; Class II; product codes OHS, OLP; 21 CFR…Independently verified
8 of 12 key facts published
INIA
Price not yet checked
FDA 510(k) K243040 — 'LED Light Therapy Mask' (SKB-1818P, SKB-1918, SKB-1918P, SKB-1918PLUS, SKB-2318L, SKB-2318P,…Independently verified
10 of 12 key facts published
Lustre
£199 checked 1 Nov 2026
FDA 510(k) K230124 — 'LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)', Class II, product codes OHS/OLP,…Independently verified
11 of 12 key facts published
MZ Skin
£599.50 checked 1 Nov 2026
FDA 510(k) K213184 (device name 'MZ Skin LightMAX Supercharged LED Mask 2.0', applicant Mz Skin, London GB; cleared 23…Independently verified
9 of 12 key facts published
Omnilux
£350.90 checked 1 Nov 2026
FDA 510(k) K191629 (device name 'faceLITE LED mask', applicant iSMART Marketing Svcs Ltd, Birmingham GB; cleared 12 Sep…Independently verified
10 of 12 key facts published
Shark
£254.99 checked 2 Nov 2026
FDA 510(k) K242796 — 'CryoGlow (FW3XXXX)', SharkNinja Operating LLC; substantially equivalent, decision 2024-11-27;…Independently verified
11 of 12 key facts published
Ulike
£169.99 checked 1 Nov 2026
FDA 510(k) K243492 (decision 10 Jan 2025) and K260511 (decision 16 Mar 2026), both 'Ulike Reglow Light Therapy Device…Independently verified
8 of 12 key facts published
The number quoted is for a different device, or the details don't match. See the mask's page for what we found.
CurrentBody
£499.99 checked 2 Nov 2026
What we found Help centre says Series 3 is 'FDA-cleared'. The K260715 summary describes a device with a different model suffix (MK-110D vs UK MK-110I), 110 LEDs…Conflicting information
11 of 12 key facts published
JOVS
£639 checked 2 Nov 2026
What we found JOVS cites no K-number. Clearance exists (confirmed in openFDA), but its link to this mask is our inference, so status is 'requested' until JOVS…Requested from manufacturer
7 of 12 key facts published
Lanveza
£159.95 checked 1 Nov 2026
What we found No K-number given. openFDA 510(k) and registration-listing searches for 'Lanveza' returned no matches (1 Nov 2026). US status only — not a UK…Conflicting information
7 of 12 key facts published
The Light Salon
£395 checked 1 Nov 2026
What we found Brand FAQ: 'FDA-Cleared Medical Device with over-the-counter clearance … 510(K) No. K191629'. The FDA record for K191629 is for 'faceLITE LED mask',…Conflicting information
7 of 12 key facts published
Therabody
£299 checked 1 Nov 2026
What we found FDA database: K230293 is 'TheraFace Mask' (the original, sibling device), Therabody Inc., cleared 2023-06-09, product code OHS. No separate 510(k)…Conflicting information
10 of 12 key facts published
9 other masks have no US clearance stated or found. Many masks are only sold in the UK and Europe, where FDA clearance doesn't apply. See all masks.