Best red light therapy masks

Who actually makes these masks

The FDA database tells you who filed the paperwork, and for LED masks the same few names keep coming up. Shenzhen Kaiyan Medical Equipment filed the 510(k)s for the CurrentBody Skin™ LED Light Therapy Mask Series 2, CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask, HIGHERDOSE Red and Infrared Light Mask and KALA Red Light Face Mask. It also holds dozens of listings under K221775, the clearance that the Bon Charge and Mito masks point to.

That one number covers a lot of masks. Under K221775 the FDA listing shows 38 different product names from several companies, Bon Charge, MitoGLOW, an older Solawave mask and CurrentBody's anti-acne mask among them. The 510(k) itself was filed by Light Tree Ventures Europe B.V. for "LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)". Omnilux's clearance, K191629, works the same way: it was filed for a device called "faceLITE", and 24 names now sit under it, from ELEMIS to CurrentBody Skin.

Same filer doesn't mean same mask. The spec sheets below differ in LED count, wavelengths and the output each brand claims. What it does mean is that the brand name on the box is often not the company that designed and built it, and a $549.99 mask and a $339.99 one can come out of the same factory paperwork.

Qure's mask is not in the Kaiyan records: its 510(k), K230042, was filed by Light Tree Ventures Europe, the same company that filed K221775.

What the numbers on a mask mean

Wavelengths. Red is 630 to 660 nm, near-infrared 830 to 850 nm. Three masks add 1072 nm: two from CurrentBody and the Omnilux Men. 14 masks add blue light between 415 and 465 nm, the band used in acne studies. Shark doesn't list wavelengths for the CryoGlow on its product page; its 510(k) summary gives 415, 630 and 830 nm.

Output. 16 of the 27 masks give an output figure, and they don't give it the same way. Some quote one total (HigherDOSE: Total irradiance 50 mW/cm² (red 26 + NIR 24)), some one figure per color (Maximum: red 20, NIR 10, blue 10 mW/cm² for Kala), some a figure per mode, and 5 only quote the number from the 510(k) summary. Only Hooga says where the figure was taken, at the surface; the rest don't say how far from the LEDs it was measured. And I found no independent measurement of any mask, so every number in the grid is the brand's own.

Two things follow. A higher number isn't a better mask: dose reviews describe a "biphasic dose response", where low levels of light often did better than high ones in cell and animal work. And because masks sit on the skin, distance matters less than with a panel, but you still can't compare two masks' figures as if they were measured the same way.

FDA-cleared, claimed, not found

21 of the 27 masks match a 510(k) clearance in the FDA database, almost all under product code OHS, the code for over-the-counter light devices for wrinkles. For the Hooga Luma LED Red Light Therapy Mask the brand gives a K-number, but the record lists other companies' masks and not Hooga's, and Hooga itself says the green 525 nm mode isn't part of the cleared uses. Dr. Dennis Gross calls its DRx SpectraLite EyeCare Max Pro and DRx SpectraLite FaceWare Pro FDA-cleared but gives no K-number, and I found no 510(k) or listing under its name; the GUDID record for the FaceWare Pro names LED Technologies as the labeler, a company with its own clearances, but no document ties one of them to these masks. The Solawave Neck & Chest Pro Light Therapy Mask (PH-n03) is registered and listed with the FDA, which is not a clearance. For the Hooga Red Light Therapy Face Mask and JOVS Red LED Light Therapy Face Mask I found no FDA record.

A clearance means the FDA found the mask substantially equivalent to one already on the market for a stated use. It doesn't mean the FDA tested it against other masks. The full list with K-numbers and dates is on the FDA-cleared LED face masks page.

What a mask can and can't do

The best evidence for red light on wrinkles is small. A 2007 randomized trial with a sham group treated 76 people with 633 nm, 830 nm or both, twice a week for four weeks, and measured wrinkle reductions of up to 36% and elasticity gains of up to 19% against baseline. A 2005 study of the Omnilux device had no control group: 31 people, and 52% improved their photoaging score by 25 to 50% by week 12.

The warning sign is a 2009 study of an amber LED device: patients reported a big improvement, while doctors and outside reviewers who didn't know who was treated saw none. A 2018 review of 31 randomized trials graded the evidence for acne as moderate and for most other skin uses, wrinkles included, as weak.

For acne, blue plus red does better. In a 2000 trial of 107 people, daily 15-minute sessions for 12 weeks cut inflamed spots by 76% on average. A Cochrane review still called high-quality evidence on light therapy for acne "lacking" and noted that two thirds of the studies were industry-sponsored.

Firmness, "tone" and glow are claims I found no trial for. What the studies show in more detail is on the red light therapy benefits page, and what results look like over time is on the before and after page.

Who should skip a mask

The most complete list I found is Shark's, on its CryoGlow product page. It says not to use the mask with "medications for severe inflammatory acne (i.e. isotretinoin or doxycycline)" or other drugs that cause light sensitivity, if you are "pregnant, nursing, or maybe pregnant", have a pacemaker or facial implants, light-induced headaches, a light-sensitive skin disorder such as lupus, retinal or macular disease, or "suspicious lesions or skin cancer". It also lists melasma, recent facial surgery, eczema, psoriasis and broken skin.

Other brands are softer and say to ask a doctor first rather than not to use it. Bon Charge's manual adds a recent steroid injection or topical steroids and a heart condition or pacemaker. CurrentBody names the photosensitizing drugs: retinoids such as tretinoin and oral isotretinoin, and antibiotics such as tetracycline and doxycycline.

Two brands ask for a test before the first full session, and it is worth doing with any mask. The manual for CurrentBody's original mask says to run a full 10-minute treatment on your forearm: if the skin stays red for more than 2 hours, you are light-sensitive and should return the mask within 14 days. Bon Charge asks for 2 minutes on the forearm at about an inch.