LED Masks With a Verifiable FDA Number (2026)

Six LED face masks have an FDA 510(k) number we could match to the mask by name on 24 Oct 2026: CurrentBody Series 2, HigherDOSE, MZ Skin LightMAX 2.0, Qure Q-Rejuvalight Pro, Shark CryoGlow and Therabody TheraFace^1,2. Three more say they are FDA-cleared, but we found no record that names them¹. The table below gives each number so you can check it yourself.

Quick picks

• Lowest price with a matching record: HigherDOSE at $349 (K241933) and Shark CryoGlow at $349.99 (K242796)^1,7,13
• Oldest record here: MZ Skin LightMAX 2.0, K213184, decided 23 Nov 2021¹
• Newest record here: CurrentBody Series 2, K250966, decided 25 Jun 2025¹
• Claims we could not match: Omnilux Contour, Dr. Dennis Gross SpectraLite FaceWare Pro and the Déesse PRO¹

Cleared is not the same as approved

Most home LED masks reach US shops through a 510(k). The FDA explains that a 510(k) shows a device is "substantially equivalent" to one already sold legally³. When that is accepted, the FDA sends an order that "'clears' the device for commercial distribution"³. That is clearance. FDA approval is a different, stricter route, and none of the six records here is an approval¹.

Clearance tells you the device may be sold for the use in the record. It does not tell you one mask works better than another. So when a page says "FDA approved", treat it as a wording error, and look for a K number.

The 6 masks with a record we could match

Notes. Records from openFDA and the FDA's 510(k) record pages, searched 24 Oct 2026; every decision reads "Substantially Equivalent"^1,2. Product code OHS is "Light Based Over The Counter Wrinkle Reduction" and OLP is "Over-The-Counter Powered Light Based Laser For Acne", both Class 2⁴. Prices in USD on each brand's own site on 24 Oct 2026^{5,7,9,11,13,15}. Masks are listed in alphabetical order. We name no winner.

To open a record, go to the FDA's 510(k) database and enter the K number, or use the record page link pattern shown in our sources². The applicant is the company that filed the record. It is not always the brand on the box, so check the device name as well.

The masks, one by one

CurrentBody Skin LED Light Therapy Mask: Series 2

• What the page says: "FDA cleared LED face mask for advanced anti-aging", with "red (633nm), near-infrared (830nm) and deep near-infrared (1072nm)" light⁵.
• Record: FDA 510(k) cleared, K250966, decided 25 Jun 2025, product code OHS^1,2.
• Price: $469.99 for the mask, $549.99 for a kit and $799.99 with a neck piece⁵.
• Session: 10 minutes, "4 times per week"⁵.
• Returns and warranty: 30 days if the item is "new and unused" with "manufacturing seals intact", and a "2 Year Warranty period as standard"⁶.
• Buyers say: Trustpilot 4.4 out of 5 from 25,195 reviews for the whole store (checked 24 Oct 2026)²⁰.
• Downside: its "reducing wrinkles by 30%" figure comes from the brand's own "56-day study" of 35 subjects⁵.

HigherDOSE Red Light Face Mask

• What the page says: "66 Dual-Core LEDs (132 Diodes)", with red at 630nm and near-infrared at 830nm⁷.
• Record: FDA 510(k) cleared, K241933, decided 27 Sep 2024, product code OHS^1,2.
• Price: $349, or $418 with a serum⁷.
• Session: 10 or 20 minutes⁷.
• Returns: the site banner shows a "120-Day Money Back Guarantee", but the policy page only spells out "a 14-day return policy for unopened Blankets"⁸. We found no return term for the mask.
• Buyers say: Trustpilot 4 out of 5 from 144 reviews (checked 24 Oct 2026)²⁰.
• Downside: the unclear return terms. Ask HigherDOSE in writing before you buy.

MZ Skin LightMAX Supercharged LED Mask 2.0

• What the page says: "Medical Grade, FDA Cleared, Dual-Action LED Face Mask for Anti-Ageing & Blemishes"⁹. It combines "red, near-infrared, and blue light"⁹.
• Record: FDA 510(k) cleared, K213184, decided 23 Nov 2021^1,2. The product code is OLP, the acne code, not the wrinkle code the other five carry^1,4.
• Price: $950⁹.
• Session: 10 minutes, "3-5 times per week"⁹.
• Returns and warranty: 30 days "after receiving your item to request a return", in the same condition, "unworn or unused"¹⁰. The 2-year warranty needs the mask "registered within 30 days"⁹.
• Buyers say: Trustpilot 2.6 out of 5 from 42 reviews (checked 24 Oct 2026)²⁰.
• Downside: it costs the most on the list, and you lose the 2-year warranty if you miss the 30-day registration⁹.

Qure Q-Rejuvalight Pro Facewear

• What the page says: it treats fine lines, sagging, inflammation and acne "in just 3 minutes a day"¹¹.
• Record: FDA 510(k) cleared, K230042, decided 28 Apr 2023, product code OHS^1,2.
• Price: $399¹¹.
• Session: 3 minutes¹¹.
• Returns: 30 days for a refund, but the policy says "We do not cover claims for efficacy within the first 30 days" and suggests at least 3 months of use¹².
• Buyers say: Trustpilot 4.5 out of 5 from 1,654 reviews for the whole store (checked 24 Oct 2026)²⁰.
• Downside: you may not know if it works before the return window closes¹².

Shark CryoGlow LED Face Mask (FW312)

• What the page says: "Clinically tested & FDA-cleared", with red, blue and infrared modes and under-eye cooling¹³.
• Record: FDA 510(k) cleared, K242796, decided 27 Nov 2024, product code OHS^1,2. The record names "CryoGlow (FW3XXXX)", with X marks in place of a full model number¹.
• Price: $349.99 on Shark's site. Amazon showed $339.99 the same day^13,14.
• Session: 4 to 8 minutes by mode¹³.
• Warranty: "Two (2) Year Limited Warranty"¹³. We could not read Shark's return window on its site.
• Buyers say: Amazon 4.4 out of 5 from 1,116 ratings (checked 24 Oct 2026)¹⁴. Trustpilot shows 2.9 out of 5 from 1,910 reviews for all SharkNinja products²⁰.
• Downside: Shark's results come from its own 12-week studies, with 60 and 59 subjects¹³.

Therabody TheraFace Mask

• What the page says: "Breakthrough FDA cleared LED skincare mask with 648 lights", in red, red plus infrared and blue, with vibration¹⁵.
• Record: FDA 510(k) cleared, K230293, decided 9 Jun 2023, product code OHS^1,2.
• Price: $649.99¹⁵.
• Session: 3 to 9 minutes¹⁵.
• Returns and warranty: returns "within 30 days of the date you received the product", and Therabody "will pay for standard return shipping"¹⁶. The page lists a "1-Year Limited Warranty"¹⁵.
• Buyers say: Trustpilot 1.7 out of 5 from 69 reviews for the whole store (checked 24 Oct 2026)²⁰.
• Downside: the second-highest price here and a low store rating^15,20.

Masks that claim clearance, but no record found by name

These pages say the mask is FDA-cleared. We searched the FDA's 510(k) database by mask name and brand on 24 Oct 2026 and could not match a record¹. That is not proof the claim is false. A record may sit under another name. But you should be able to ask the brand for the number and get it.

Notes. Prices on each brand's site on 24 Oct 2026^17,18,19. Searches in openFDA¹.

• Dr. Dennis Gross. Records exist for devices named "dpl SpectraLite" (K171386, 7 Aug 2017) and "dpl Faceware" (K183247, 14 Mar 2019)¹. The applicant on both is Led Technologies, Inc., not Dr. Dennis Gross, and neither record names this product. We could not confirm that either covers this mask. The mask has a 3-minute session and red or blue light¹⁸. Trustpilot showed 2.2 out of 5 from 8 reviews (checked 24 Oct 2026)²⁰.
• Omnilux Contour. The Omnilux records we found name other devices, such as K210948 for Omnilux CLEAR, an acne device with product code OLP, decided 24 Jun 2021^1,2. None names Contour¹. The Contour page suggests "three to five 10-minute treatments per week"¹⁷. Trustpilot showed 2.2 out of 5 from 232 reviews (checked 24 Oct 2026)²⁰.
• Déesse PRO. The product data on the PRO page lists "FDA approved" among its certifications¹⁹. The site menu describes a different model, EOS-X, as "FDA-cleared for the treatment of acne and anti-ageing"¹⁹. We found no 510(k) record under Déesse by name or applicant¹.

How to check an LED mask's FDA number yourself

1. Find the K number. Look on the product page, the box or the manual. It starts with K and has six digits, such as K250966.
2. Search the FDA database. Enter the number in the FDA's 510(k) search². If the brand gives no number, search the device name.
3. Match the device name. The record should name the mask or its model, not a different device from the same brand.
4. Check the product code. OHS covers over-the-counter wrinkle reduction and OLP covers over-the-counter acne devices⁴. The code tells you what use was cleared.
5. Check the date. A record cleared before a model was redesigned may not cover the new model. Ask the brand if you are unsure.

If the brand will not give you a number, that is useful to know before you spend $350 or more.

What the research says about LED light

A 2023 systematic review and meta-analysis looked at 31 studies of LED skin therapy²¹. It found that "both red and blue LED lights play an important role in the treatment of acne vulgaris"²¹. It also reported consistent results for skin rejuvenation with near-infrared and other LEDs²¹. The authors concluded that "LEDs are useful for dermatology"²¹. The review did not test any mask on this page. A 510(k) record and a good review score are separate questions from whether a mask will work for you.

Products we left out

We kept to masks we could check on brand pages, in the FDA database and on review sites on the same day. Masks from brands such as Aphrona, Solawave and Mito Red Light appear in search results for this topic, but we did not check them on 24 Oct 2026, so they are not on this page. If you are weighing one of them, use the five steps above.

Where to go next

• For six cheaper or similar masks built around Omnilux, see Omnilux alternatives.
• For the same idea built around CurrentBody, see CurrentBody alternatives.
• For two head-to-heads, see CurrentBody vs Omnilux and Omnilux vs Shark.
• Using a mask after microneedling? Read LED mask after microneedling.

This page lists records, not rankings. We give no scores here because a matching record says nothing about results. All facts come from public information checked on 24 Oct 2026. We did not test these products.

Last checked 24 Oct 2026.