LED Face Mask Brands Compared: What Their 8 FDA Files Say

Quick Answer: We read the eight FDA 510(k) clearance files behind the best-known LED face mask brands: Shark CryoGlow, three CurrentBody masks, two Omnilux masks, Therabody’s TheraFace Mask and the HigherDose mask. In all eight, the clearance rested on bench testing. Seven say in words that clinical testing was “not needed”, “not required” or not performed, and Shark’s lists only non-clinical tests. Each mask was cleared by showing it matches an earlier mask, which in turn had matched an earlier one. The files also show things the box does not: the Omnilux Contour FACE is filed under the name “faceLITE”, and the newest CurrentBody mask’s red and near-infrared mode is cleared as a heating lamp for muscle and joint pain, not for wrinkles. No brand-name study of a Shark, CurrentBody or TheraFace mask appears in PubMed. An advertisement for a mask from another brand is in the box near the end of this page.

Our red light therapy mask page covers the category as a whole: the 65 masks FDA has cleared and the two sham-controlled trials of masks, which disagree. This page goes brand by brand, using each company’s own filing.

LED face mask brands at a glance

Every row below comes from FDA’s 510(k) database and the summary document attached to each clearance, read on 31 October 2026. “Applicant” is the company that filed, which is often the factory rather than the brand.

Why none of them needed a clinical test

A 510(k) clearance is not a finding that a device works. Under FDA’s 510(k) route, a moderate-risk device can be sold once the maker shows it is “substantially equivalent” to a device already legally on the market. In plain terms, the company shows its mask is like a mask FDA already allowed. If the light colours, the power reaching the skin and the intended use line up, bench measurements can be enough.

That is what these files did. Shark’s summary is the most explicit about how. It says the critical parameter was “the total energy delivered from the device into the face”, calculated from the LEDs’ power density and the treatment times. It also records an assumption: “Additional research supports that, when calculating the overall dose for CryoGlow, red and infrared light are considered equal.” From those calculations, Shark concluded that each CryoGlow routine delivers a dose equivalent to the TheraFace mask it compared itself with.

None of this means the masks are unsafe or that they cannot work. The point is that the FDA record for a branded mask tells you the mask is electrically safe and emits roughly the same light as an earlier mask. It does not tell you how much a wrinkle changed on anyone wearing it.

Shark CryoGlow: a copy of a copy of a copy

Shark’s file names Therabody’s TheraFace Mask (K230293) as its predicate, and the MZ Skin LightMAX Supercharged LED Mask 2.0 (K213184) as a reference device. Following each file back:

• Shark CryoGlow (2024) claimed equivalence to the TheraFace Mask. Bench testing only.
• TheraFace Mask (2023) named the LightMAX 2.0 as its primary predicate. “There were no clinical studies performed.”
• MZ Skin LightMAX 2.0 (2021) named Omnilux CLEAR among its predicates. Non-clinical testing only.
• Omnilux CLEAR (2021): “Since the Omnilux CLEAR mask raises no new questions in terms of safety and efficacy, clinical data is not required.”

Four masks in a row, each cleared by matching the one before, and no clinical test anywhere in the four files.

The file also describes the product in more detail than the box does. CryoGlow has 480 LEDs (160 three-colour packages) emitting blue at 415 nm, red at 630 nm and infrared at 830 nm, each ±10 nm, across three routines: Better Aging (red and infrared), Skin Clearing (blue, red and infrared) and Skin Sustain (blue and red). The “cryo” part is under-eye chill pads cooled by Peltier elements and fans. The file is clear about what the cooling is for: it is “intended for refreshing/invigorating/soothing the skin only.” The clearance covers the light, for wrinkles and acne, and nothing about the cooling.

CurrentBody: three masks, one heating-lamp mode

CurrentBody, the UK brand whose masks are among the most searched, appears in FDA’s database under three mask clearances. Two were filed by Shenzhen Kaiyan Medical Equipment, a Chinese manufacturer that holds 29 clearances in FDA’s database under its own name, including masks sold as HigherDose, Solawave, Aduro and KALA. The newest was filed by The Beauty Tech Group.

Series 2 (K250966). Cleared for “the treatment of full-face wrinkles”. Its predicate is an unbranded “LED Light Therapy Mask (model: MK66R-B)” cleared in 2022 (K221946). The file states: “Clinical testing is not needed for this 510(k).”

The 2026 Multi Light mask (K260715) is the one to read closely. It has four modes, and FDA cleared them for different things:

So the red-plus-infrared mode, the combination most people buy an LED mask for, is cleared on this device under the infrared heating-lamp code (ILY, 21 CFR 890.5500), the same code used for heat lamps and pain belts. To support it, the file cites a body panel, the Lumaflex Panel (K260129), as a predicate for “the ILY therapeutic heating intended purpose”. On this mask, wrinkles are assigned to the yellow and infrared mode. Again: “Clinical performance testing was not needed for this 510(k).”

We found no record named “Series 1” when searching FDA’s database for CurrentBody. That does not mean the original mask is uncleared; a mask can be cleared under a factory or model name. It does mean that the way to check is to ask the seller for the K-number, not to search the brand.

Omnilux: the most studies, and a mask filed as “faceLITE”

Search FDA’s database for “Omnilux” and you find eight clearances, almost all from 2003 to 2009 for clinic panels and a handheld device, plus the 2021 Omnilux CLEAR acne mask. The Omnilux Contour FACE, the brand’s wrinkle mask, is not among them under that name. Its entry in the US Global Unique Device Identification Database (GUDID), the device ID register, lists the brand name “Omnilux Contour FACE” and the premarket submission K191629. In FDA’s 510(k) database, K191629 is the “faceLITE”, filed in 2019 by Ismart Marketing Svcs and cleared “for the use in the treatment of full-face wrinkles”. Its predicate was the LG Beauty LED mask (K170984), and it says “clinical data is not required.”

Omnilux is also the only brand here with its name in published studies, though none of them is a sham-controlled trial of a home mask:

• Omnilux Revive, 2005. A clinic panel, not a mask. 23 volunteers had one half of the face treated three times a week for three weeks, and the untreated half served as the control. Blinded photo assessment found a response in 59%, but “objective analysis failed to show statistically significant changes in skin hydration or elasticity.”
• Omnilux handheld, 2008. 22 people, no control group. 74% reported visible improvement in fine lines at 8 weeks.
• Omnilux CLEAR mask, 2025. 30 people aged 14 to 45 with mild-to-moderate acne used the mask at home 4 times a week for 7 weeks. Spot counts fell (p<0.0001) and 86% improved by at least one grade. The author lists “the open-label study design” as the main limitation: everyone knew they were using the real mask, and there was no comparison group.

TheraFace and HigherDose

Therabody TheraFace Mask (K230293) is cleared mode by mode: red light and red plus infrared “to treat full face wrinkles”, blue light “to treat mild to moderate inflammatory acne”. Its wavelengths are 415 nm blue, 633 nm red and 830 nm infrared. The file says plainly: “There were no clinical studies performed.” It became the predicate for Shark’s mask a year later.

HigherDose Red and Infrared Light Mask (K241933) is cleared for full-face wrinkles only, so it is not cleared for acne. It was filed by Shenzhen Kaiyan, the same factory as two CurrentBody masks, and it cites three earlier masks as predicates, two of them cleared in 2022 (K221775 and K214103) and one in 2021 (K202390). “Clinical testing was not needed for this 510(k).”

What the trials of masks found, without brand names

The controlled evidence for LED masks comes from trials that tested a mask without a famous brand on it. Our mask page covers both sham-controlled trials in full. In short, a 630/850 nm mask beat a sham device for crow’s feet over 16 weeks in 60 adults, and a 660 nm mask did not beat sham on a specialist-scored wrinkle scale after four weeks in 95 women. Neither tested a Shark, CurrentBody, Omnilux, TheraFace or HigherDose mask.

So when a brand says its mask is “clinically proven”, look for the study behind the claim. Check whether it tested that mask, whether there was a sham device, and who was blinded. A clearance letter is not that study.

How to compare LED face mask brands

• Ask for the K-number and read the indication. Look it up in FDA’s 510(k) database and open the summary PDF. “Full-face wrinkles” and “inflammatory acne” are separate clearances; a mask cleared only for wrinkles, like the HigherDose and Series 2 masks, is not cleared for acne.
• Check which mode is cleared for what. On the CurrentBody MK-110D, red plus infrared is a heating mode for muscle and joint pain, and wrinkles are assigned to yellow plus infrared.
• Don’t pay extra for extras the clearance doesn’t cover. Shark’s cooling is for “refreshing/invigorating/soothing the skin only”, and CurrentBody’s green mode is “for user comfort and relaxation purposes only”.
• Read brand studies for their design. The Omnilux studies are open-label or compare one half of the face with the other; none compared a home mask with a sham.
• Protect your eyes and see our red light therapy dangers page if you take a medicine that makes you sensitive to light.

We do not rank these brands against each other. Their FDA files give no clinical basis for a ranking, and no trial has compared one brand with another.

Frequently Asked Questions

Which LED face mask brands are FDA cleared?

All of the brands on this page hold at least one FDA 510(k) clearance for a mask: Shark (K242796), CurrentBody (K250966, K242593, K260715), Omnilux (K191629 for the Contour FACE, filed as “faceLITE”, and K210948 for CLEAR), Therabody (K230293) and HigherDose (K241933). Clearance means the mask was shown to be substantially equivalent to an earlier one, not that it was proven to work.

Is the Shark CryoGlow FDA cleared?

Yes. K242796, cleared on 27 November 2024 for fine lines and wrinkles (red and infrared) and mild-to-moderate inflammatory acne (red, blue and infrared). The clearance was based on bench testing against Therabody’s TheraFace Mask. The under-eye cooling is described as for “refreshing/invigorating/soothing the skin only.”

Is the Omnilux Contour FACE FDA cleared?

The US device ID register (GUDID) links the Omnilux Contour FACE to K191629, which FDA’s 510(k) database lists as the “faceLITE” mask, cleared in 2019 for full-face wrinkles. The summary says clinical data was not required.

Is CurrentBody or Omnilux better?

No trial has compared them. Omnilux has published studies, but they used a clinic panel, a handheld device or an open-label design rather than a sham-controlled test of the home mask. No study of a CurrentBody mask appears in PubMed.

Does FDA clearance mean an LED mask works?

No. A 510(k) clearance means the device was shown to be substantially equivalent to one already on the market for the same use. All eight brand files on this page relied on bench testing, and seven state that clinical testing was not needed or not performed.

What does “red and infrared” do on the new CurrentBody mask?

On the CurrentBody Skin LED Multi Light Therapy Mask (K260715), the red plus near-infrared mode is cleared for “topical heating” and “the temporary relief of minor muscle and joint pain”. The wrinkle clearance on that mask belongs to the yellow plus near-infrared mode.

Sources

1. FDA 510(k) summary K242796, CryoGlow (FW3XXXX), SharkNinja Operating LLC, cleared 27 November 2024, product code OHS. accessdata.fda.gov. 480 LEDs (160 tri-wick packages); 415, 630 and 830 nm ±10 nm; predicate TheraFace K230293, reference LightMAX K213184; “red and infrared light are considered equal”; cooling “for refreshing/invigorating/soothing the skin only”. Checked 31 October 2026.
2. FDA 510(k) summary K250966, CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H), Shenzhen Kaiyan Medical Equipment, cleared 25 June 2025. accessdata.fda.gov. Full-face wrinkles; predicate K221946; “Clinical testing is not needed for this 510(k)”. Checked 31 October 2026.
3. FDA 510(k) summary K242593, CurrentBody LED 4 in 1 Zone Facial Mapping Mask, Shenzhen Kaiyan Medical Equipment, cleared 14 February 2025. accessdata.fda.gov. “Clinical testing was not needed for this 510(k)”. Checked 31 October 2026.
4. FDA 510(k) summary K260715, CurrentBody Skin LED Multi Light Therapy Mask (MK-110D), The Beauty Tech Group, cleared 3 June 2026, product codes OHS, OLP, ILY. accessdata.fda.gov. Four modes and indications as quoted; tertiary predicate Lumaflex Panel K260129 for “the ILY therapeutic heating intended purpose (21 CFR 890.5500)”; “Clinical performance testing was not needed for this 510(k)”. Checked 31 October 2026.
5. FDA 510(k) summary K191629, faceLITE LED mask, Ismart Marketing Svcs Ltd, cleared 12 September 2019. accessdata.fda.gov. Full-face wrinkles; predicate LG Beauty LED mask K170984; “clinical data is not required”. Checked 31 October 2026.
6. AccessGUDID device record, Omnilux Contour FACE, I-SMART Developments Limited, model TN19G, DI 05060534510128: premarket submission K191629, product code OHS. accessgudid.nlm.nih.gov. Checked 31 October 2026.
7. FDA 510(k) summary K210948, Omnilux CLEAR, Globalmed Technologies, cleared 24 June 2021. accessdata.fda.gov. Mild to moderate acne vulgaris; “clinical data is not required”. Checked 31 October 2026.
8. FDA 510(k) summary K230293, TheraFace Mask, Therabody Inc, cleared 9 June 2023. accessdata.fda.gov. Mode indications as quoted; primary predicate MZ Skin LightMAX 2.0 K213184; “There were no clinical studies performed”. Checked 31 October 2026.
9. FDA 510(k) summary K213184, MZ Skin LightMAX Supercharged LED Mask 2.0. accessdata.fda.gov. Predicates include Omnilux CLEAR K210948; non-clinical performance testing. Checked 31 October 2026.
10. FDA 510(k) summary K241933, HIGHERDOSE Red and Infrared Light Mask (MK66-L), Shenzhen Kaiyan Medical Equipment, cleared 27 September 2024. accessdata.fda.gov. Full-face wrinkles; predicates K221775, K214103, K202390; “Clinical testing was not needed for this 510(k)”. Checked 31 October 2026.
11. openFDA device 510(k) API, searches by device name (CryoGlow, CurrentBody, Omnilux, TheraFace, HIGHERDOSE) and by applicant (Shenzhen Kaiyan: 29 records; Light Tree Ventures). open.fda.gov. Checked 31 October 2026.
12. US Food and Drug Administration. Premarket Notification 510(k) and consumer device guidance on clearance versus approval. fda.gov. Checked 31 October 2026.
13. Bhat J, Birch J, Whitehurst C, Lanigan SW. A single-blinded randomised controlled study to determine the efficacy of Omnilux Revive facial treatment in skin rejuvenation. Lasers Med Sci. 2005;20(1):6-10. PubMed 15909229. 23 volunteers, half-face untreated control; 59% response on blinded photos; no significant change in hydration or elasticity. Checked 31 October 2026.
14. Sadick NS. A study to determine the efficacy of a novel handheld light-emitting diode device in the treatment of photoaged skin. J Cosmet Dermatol. 2008;7(4):263-7. PubMed 19146602. 22 subjects, Omnilux handheld, 74% reported improvement at 8 weeks. Checked 31 October 2026.
15. Ablon G. A 7-Week, Open-Label Study Evaluating the Efficacy and Safety of 415-nm/633-nm Phototherapy for Treating Mild-to-Moderate Acne in Adolescents and Adults. J Clin Aesthet Dermatol. 2025;18(10):25-32. PubMed 41416031. Omnilux Clear, 30 patients aged 14 to 45, 4 times weekly for 7 weeks; p<0.0001; 86% at least 1-grade IGA reduction; open-label. Checked 31 October 2026.
16. Park SH, et al. Clinical study to evaluate the efficacy and safety of home-used LED and IRED mask for crow’s feet: a multi-center, randomized, double-blind, sham-controlled trial. Medicine (Baltimore). 2025;104:e41596. PubMed 39960921. 60 adults aged 30 to 65; 630 nm LED + 850 nm; significant differences from sham at 8, 12 and 16 weeks. Checked 31 October 2026.
17. Bragato EF, et al. Role of photobiomodulation application frequency in facial rejuvenation: randomized, sham-controlled, double-blind, clinical trial. Lasers Med Sci. 2025;40:170. PubMed 40167796. 95 women aged 45 to 60; 2 or 3 sessions a week for four weeks vs sham. Checked 31 October 2026.
18. PubMed searches for “CurrentBody”, “TheraFace” and “SharkNinja OR CryoGlow”: no study of these masks (0, 0 and 7 unrelated records). pubmed.ncbi.nlm.nih.gov. Checked 31 October 2026.
19. FliKEZE PhotonMask Quint product page. flikeze.com. Checked 31 October 2026.