Roundup
LED masks with a clearance number you can actually look up
Everyone writes FDA cleared on the box. Very few will give you the number. We searched the public database device by device and published what came back, including the blanks.
By Selena H. · Published October 13, 2026
Illustrative photograph, not a picture of a specific device.
Disclosure: Glow & Current earns a commission when you buy through links on this page, at no extra cost to you. It does not change which device wins or what we say about it — here is exactly how we are funded, and here is how we evaluate devices.
The FDA's 510(k) database is free, public and searchable by anyone with a browser. It took us an afternoon to look up every mask in this category. As far as we can tell, no other publisher covering these products has done it, and that is the single most useful thing this site does.
Quick picks
The short answer
| # | Product | Best for | FDA clearance | Price |
|---|---|---|---|---|
| 1 |  CurrentBody Skin LED Light Therapy Mask Series 2 Cleanest clearance record | verifiable paperwork | Located | |
| 2 | Shark CryoGlow Broadest indications | acne and wrinkles in one clearance | Located | |
| 3 |  Therabody TheraFace Mask Cleared under the manufacturer's own name | a direct accountability chain | Located | |
| 4 | CurrentBody Skin LED Multi Light Therapy Mask (Series 3) Most recent clearance | the current flagship | Located | |
| 5 |  HigherDOSE Red Light Face Mask Best cleared cheaper mask | a record without the flagship price | Located | |
| 6 | Omnilux Clear Only located acne-code clearance | acne specifically | Located |
Prices are checked live and stamped with the date they were read. No live price is held for these listings right now, so every button reads “Check price on Amazon” rather than showing a number we cannot stand behind. Last price check: October 13, 2026.
Definitions
What a 510(k) clearance means
A 510(k) is a premarket notification. The manufacturer demonstrates that its device is substantially equivalent to a device already legally on the market. It is a real review with real requirements, and it is not the same as FDA approval, which is a separate and much higher bar applied to high-risk devices.
No LED face mask is FDA approved. Every one that is legitimately regulated is FDA cleared. Any retailer or brand writing approved is either careless or hoping you will not notice. We explain the distinction properly here.
What came back
The full search result
| Device as cleared | K-number | Decision date | Applicant | Code |
|---|---|---|---|---|
| CurrentBody Skin LED Mask Series 2 (MK-90H) | K250966 | 25 Jun 2025 | Shenzhen Kaiyan Medical Equipment | OHS |
| CurrentBody Skin LED Multi Light Mask (MK-110D) | K260715 | 3 Jun 2026 | The Beauty Tech Group | OHS |
| CurrentBody LED 4 in 1 Zone Facial Mapping Mask | K242593 | 14 Feb 2025 | Shenzhen Kaiyan Medical Equipment | OHS |
| CryoGlow (FW3XXXX) | K242796 | 27 Nov 2024 | SharkNinja Operating, LLC | OHS |
| TheraFace Mask | K230293 | 9 Jun 2023 | Therabody, Inc. | OHS |
| HigherDOSE Red and Infrared Light Mask (MK66-L) | K241933 | 27 Sep 2024 | Shenzhen Kaiyan Medical Equipment | OHS |
| Omnilux CLEAR | K210948 | 24 Jun 2021 | Globalmed Technologies | OLP |
| Omnilux New-U | K072459 | 3 Mar 2008 | Photo Therapeutics, Inc. | OHS |
| Solawave 2-in-1 Skincare Mini | K250532 | 22 May 2025 | Shenzhen Kaiyan Medical Equipment | OHS |
The blanks
The devices that returned nothing
This is the part other publishers leave out, and it is more interesting than the list above.
| Device | What we searched | Result |
|---|---|---|
| Omnilux Contour Face | device name, brand, applicant Omnilux and Globalmed | No record under Contour. Brand's OHS record on file is K072459, from 2008 |
| Dr. Dennis Gross DRx SpectraLite FaceWare Pro | applicant Gross, device names FaceWare and SpectraLite | No record. dpl Faceware (K183247) and dpl SpectraLite (K171386) belong to LED Technologies, Inc., a different company |
| JOVS LED masks | device name JOVS | Only IPL and microcurrent records. No LED mask clearance |
| Qure LED masks | device name and brand Qure | No record |
| iRestore Illumina Face Mask | device name iRestore | Only low-level laser hair-growth records (product code OAP) |
In detail
Every pick, and why
No. 1 · Cleanest clearance record
CurrentBody Skin LED Light Therapy Mask Series 2
CurrentBody · Best for verifiable paperwork
K250966, cleared 25 June 2025, applicant Shenzhen Kaiyan Medical Equipment, product code OHS. The record names the exact model, MK-90H. That is as clean as this category gets.
The three-wavelength silicone mask that made CurrentBody the default recommendation, and the one device in this comparison whose exact 510(k) we can cite.
Specifications
| Wavelengths | 633 nm red, 830 nm near-infrared, 1072 nm deep near-infrared |
|---|---|
| LEDs | 236 bulbs |
| Irradiance | Not published by the manufacturer |
| Session | 10 minutes, 3-5 times a week |
| Clearance | K250966, 25 June 2025, product code OHS |
FDA clearance located
510(k) K250966 (CurrentBody Skin LED Light Therapy Mask Series 2, model MK-90H, cleared 25 June 2025, applicant Shenzhen Kaiyan Medical Equipment Co., Ltd., product code OHS - light-based over-the-counter wrinkle reduction).
What works
- A 510(k) number we located for this exact model and can cite
- Three wavelengths including 1072 nm
- Nearly twice the diode count of the Omnilux
What does not
- No irradiance figure published anywhere, so diode count cannot be converted into delivered dose
- No blue light on this model
- Superseded in the lineup by the Series 3, which affects resale and support horizon
Specifications from CurrentBody product page; FDA 510(k) K250966, checked 13 October 2026.
No. 2 · Broadest indications
Shark CryoGlow
Shark Beauty · Best for acne and wrinkles in one clearance
K242796, cleared 27 November 2024, SharkNinja Operating LLC. The indications cover red and infrared for lines and wrinkles and red, blue and infrared for mild-to-moderate inflammatory acne. Two indications on one record is rare here.
A rigid LED mask with an under-eye cooling plate, and the only device in this category whose 510(k) explicitly covers both wrinkles and inflammatory acne.
Specifications
| Wavelengths | 630 nm red, blue, 830 nm infrared |
|---|---|
| LEDs | 160 tri-wick LEDs delivering 480 light sources |
| Irradiance | Not published by the manufacturer |
| Routines | Better Aging 6 minutes, Skin Sustain 4 minutes, Skin Clearing |
| Clearance | K242796, 27 November 2024, product code OHS |
FDA clearance located
510(k) K242796 (CryoGlow FW3XXXX, cleared 27 November 2024, applicant SharkNinja Operating LLC, product code OHS). The indications cover red and infrared for lines and wrinkles, and red, blue and infrared for mild-to-moderate inflammatory acne.
What works
- A located clearance that names acne as well as wrinkles, which almost none of this category does
- Under-eye cooling is a genuine feature, not a spec-sheet filler
- Three selectable routines instead of one fixed cycle
What does not
- Rigid shell does not conform to the face the way silicone does
- No published irradiance
- Heaviest and bulkiest option here
Specifications from FDA 510(k) K242796; Shark product listing, checked 13 October 2026.
No. 3 · Cleared under the manufacturer's own name
Therabody TheraFace Mask
Therabody · Best for a direct accountability chain
K230293, cleared 9 June 2023, applicant Therabody, Inc. Most masks in this category are cleared under a contract manufacturer's name. This one is under the brand you are buying from.
The highest diode count of the rigid masks, with vibration therapy layered on top of three wavelengths.
Specifications
| Wavelengths | 633 nm red, 830 nm near-infrared, 415 nm blue |
|---|---|
| LEDs | 648 |
| Irradiance | Not published by the manufacturer |
| Session | 3-9 minutes depending on program |
| Warranty | 1-year limited |
| Clearance | K230293, 9 June 2023, product code OHS |
FDA clearance located
510(k) K230293 (TheraFace Mask, cleared 9 June 2023, applicant Therabody, Inc., product code OHS - light-based over-the-counter wrinkle reduction).
What works
- A located 510(k) for this exact device
- Red, near-infrared and blue in one mask with a published warranty
- Vibration is a real differentiator if you use it for tension as well as skin
What does not
- No published irradiance
- Rigid, heavy, and it sits away from the skin at the cheekbones
- Vibration adds cost that does nothing for the photobiomodulation case
Specifications from Therabody product page; FDA 510(k) K230293, checked 13 October 2026.
No. 4 · Most recent clearance
CurrentBody Skin LED Multi Light Therapy Mask (Series 3)
CurrentBody · Best for the current flagship
K260715, cleared 3 June 2026, The Beauty Tech Group Ltd., model MK-110D. The newest record in this category by some margin.
CurrentBody's current flagship: six wavelengths and 750 diodes, the highest published count of any consumer face mask we tracked.
Specifications
| Wavelengths | 633 nm, 830 nm, 1072 nm, 415 nm blue, 532 nm green, 590 nm yellow |
|---|---|
| LEDs | 750 bulbs |
| Irradiance | Not published by the manufacturer |
| Session | 10 minutes, 3-5 times a week |
| Clearance | K260715, 3 June 2026, product code OHS |
FDA clearance located
510(k) K260715 (CurrentBody Skin LED Multi Light Therapy Mask, model MK-110D, cleared 3 June 2026, applicant The Beauty Tech Group, Ltd., product code OHS).
What works
- A located, current 510(k) for this exact model
- The only mainstream mask carrying blue, green and yellow alongside red and near-infrared
- Highest published diode count in the category
What does not
- Still no published irradiance, so 750 diodes is a count and not a dose
- The green and yellow evidence base is far thinner than red, near-infrared and blue
- You are paying for three wavelengths most buyers will never select
Specifications from CurrentBody product page; FDA 510(k) K260715, checked 13 October 2026.
No. 5 · Best cleared cheaper mask
HigherDOSE Red Light Face Mask
HigherDOSE · Best for a record without the flagship price
K241933, cleared 27 September 2024, model MK66-L. Same contract manufacturer as several rivals, which is worth knowing and is not a criticism.
A flexible red and near-infrared mask with a located clearance and no blue light.
Specifications
| Wavelengths | Red and near-infrared |
|---|---|
| Irradiance | Not published by the manufacturer |
| Clearance | K241933, 27 September 2024, product code OHS |
FDA clearance located
510(k) K241933 (HigherDOSE Red and Infrared Light Mask, model MK66-L, cleared 27 September 2024, applicant Shenzhen Kaiyan Medical Equipment Co., Ltd., product code OHS).
What works
- A located, recent 510(k) for this exact model
- Flexible shell at a lower tier than the flagship silicone masks
- Red and near-infrared with no filler wavelengths
What does not
- No published irradiance or diode count
- No blue light
- Built by the same contract manufacturer as several rivals, so the differentiation is largely branding
Specifications from FDA 510(k) K241933, checked 13 October 2026.
No. 6 · Only located acne-code clearance
Omnilux Clear
Omnilux · Best for acne specifically
K210948, cleared 24 June 2021, product code OLP, which exists specifically for light-based over-the-counter acne treatment. It is the only mask here cleared under that code.
The acne-focused mask in the Omnilux line: red plus blue, and the only Omnilux face device with a located acne clearance behind it.
Specifications
| Wavelengths | 633 nm red, 415 nm blue |
|---|---|
| LEDs | 132 (66 red, 66 blue) |
| Irradiance | 44 mW/cm2, brand-stated, not independently verified |
| Clearance | K210948, 24 June 2021, product code OLP |
| Protocol | 3-5 sessions a week for 4-6 weeks |
FDA clearance located
510(k) K210948 (Omnilux CLEAR, cleared 24 June 2021, applicant Globalmed Technologies, product code OLP - light-based over-the-counter acne treatment). An earlier Omnilux Clear-U record exists as K081307 (January 2009).
What works
- An acne clearance we could actually find and cite, which is rare in this category
- Highest brand-stated irradiance in the Omnilux face line
- Blue at 415 nm is the wavelength the acne literature actually studies
What does not
- No near-infrared, so it is a single-purpose device
- Buying it alongside a red/NIR mask means owning two masks
- No published warranty
Specifications from Omnilux product page; FDA 510(k) K210948, checked 13 October 2026.
Do it in five minutes
How to check a device yourself
- Go to the FDA 510(k) premarket notification database.
- Search by device name first. Many consumer devices are cleared under a model code rather than the retail name, so also try the brand as applicant.
- Check the product code. OHS is wrinkle reduction, OLP is acne, NFO is facial toning, OHT is hair removal, PAY is radiofrequency. A clearance in the wrong code does not cover the claim being made.
- Check the applicant. A clearance under a contract manufacturer's name is still a clearance; it just means the accountability chain runs through a factory rather than the brand.
- Check the date. A 2008 clearance for a discontinued device tells you nothing about the mask you are about to buy.
FAQ
Questions people actually ask
Which LED face masks are actually FDA cleared?
Is FDA cleared the same as FDA approved?
Does a clearance mean the mask works?
Why are so many masks cleared under Chinese manufacturer names?
Sources
Where this page’s facts come from
Read next
Keep going
- FDA cleared vs FDA approved, and how to check either one
The difference between clearance and approval, what the product codes mean, and a five-minute method for checking any device yourself.
- The best LED face masks, ranked on what you can actually verify
Nine masks ranked on wavelengths, diode counts, brand-stated irradiance and located FDA clearance numbers.
- The best LED mask for acne, starting with which ones are cleared for it
Blue-light masks compared on acne-specific FDA clearance, published wavelengths and when a mask is the wrong tool entirely.
- Shark CryoGlow review
A dual-indication clearance, under-eye Peltier cooling and three routines, in a shell that does not conform to your face.
- CurrentBody Skin LED Mask Series 2 review
Three wavelengths, 236 diodes and a 510(k) naming the exact model - against a stubbornly unpublished irradiance.