Verified Beauty Data

Buyer's guide / LED face masks

The best red light therapy mask

Updated October 9, 2026 · 74 masks checked

Buy the Shark CryoGlow ($299 on Amazon). FDA cleared it for wrinkles and acne under Shark's own name. Amazon sells it, and it was the best-selling LED face mask on Amazon when we checked on October 9, 2026. We checked 74 LED face masks against FDA records to find it.

How we picked: we kept masks with an FDA record tied to that exact product (FDA's filing or device listing names this mask, or the brand gives the K number and the mask's model is in that filing) and that Amazon or the brand itself sells. A model number that matches a factory's filing was not enough on its own. Then we took the best seller at any price, under $150, and over $350. Prices seen October 9, 2026. Some links earn us a commission. It does not change the picks.

Which one is right for you?

What using each one looks like

Photos and the claims printed on them are each brand's own, from its Amazon listing. Tap a photo to see the listing.

01 / Do they work?

Yes, a little, if you use one for months

LED masks are not a scam, and they are not a facelift. The American Academy of Dermatology says red light devices "can produce subtle to noticeable results on the face," based on "some studies." The research is real but early: the trials are small, and few of them test the masks you can buy.

What "FDA cleared" means. FDA decided the mask is similar to one already sold, mostly on safety. It does not mean FDA tested whether it works. The FDA filing for CurrentBody's Series 2 says "Clinical testing is not needed for this 510(k)." K250966

02 / Cheap or expensive?

Most masks we could check use the same colors of light. How much light you get is not the same.

17 of the 21 masks whose specs we read use red light near 630 nm and near-infrared near 830 to 850 nm, the colors the studies used, at prices from $89.99 to $749. Four things differ, and they are why we picked what we did.

  1. 1. Whether the FDA filing really covers it

    18 of the 74 masks have FDA records tied to that exact product. 16 more have a likely FDA filing we could not tie to the exact mask. 11 say "FDA" and we found no matching record. Of the 19 masks with "FDA" in their Amazon title, 7 had no filing we could match.

  2. 2. How much light actually reaches your skin

    Light power on the skin is measured in mW/cm². Where an independent tester measured masks, output ran from 8 to about 27 mW/cm². Filings run higher than meters: CurrentBody's Series 2 filing states 30 and a tester measured 18.5; Qure's filing states 70 and the same tester measured 8. The two mask trials that compared a real mask with a fake one used about 6 to 10 mW/cm² of each color, so more light is not proven to work better. Most masks have never been measured at all.

  3. 3. Who sells it

    Amazon sells the Shark and the LifePro itself, so returns go through Amazon. The Omnilux Contour on Amazon comes from a third-party store at $442.99; Omnilux sells it for $395.

  4. 4. Fit, comfort and warranty

    You need to wear it 3 to 5 times a week for months, so it has to be easy to use. Warranties run 1 to 2 years among the masks we read; the Shark and CurrentBody come with 2.

Light measured at the mask, mW/cm² (one independent tester's meter). Light power on the skin, all colors added up. The shaded band is what the two trials that compared a real mask with a fake one used (6.4 to 20).
Omnilux 26.7*
HigherDOSE 26*
CurrentBody 18.5
iRestore 10.5
Qure 8

* Worked out from the light dose the tester reported for a 10-minute session. The Shark and LifePro have not been measured; Shark's filing states 128.

Why the Shark. A filing in Shark's own name for wrinkles and acne, sold by Amazon, a 2-year warranty, and three timed light programs plus an under-eye cooling mode. Some owners find the hard shell heavy. Shark says it ran 12-week studies of 59 people (lines) and 60 people (acne); those are Shark's own studies. Two things to know: no independent tester has measured its light, and its own filing lists 64 mW/cm² of red plus 64 of infrared in the lines program, about 6 to 10 times what the mask trials used for each color. A filing is not a measurement: in two cases we could check, CurrentBody's filing said 30 and a tester measured 18.5, and Qure's said 70 and a tester measured 8. Shark's directions say to use it daily.

03 / The FDA check

74 LED face masks on Amazon, checked against FDA records

We looked for each mask in FDA's 510(k) database (its list of cleared devices) by brand, product name and model number. Each K number links to the filing. Masks with an FDA record tied to them come first, best sellers first. For the big brands sold outside Amazon too (Solawave, CurrentBody Series 3, Therabody), see which LED face masks are FDA cleared.

1351671122
  • 13 FDA's filing or device listing names this mask or brand
  • 5 The factory's FDA filing lists this mask's own model, and FDA's listing or the brand ties it to this mask
  • 16 We found a likely FDA filing but could not tie it to this exact mask
  • 7 The brand has an FDA clearance, but not for this model
  • 11 The listing says FDA cleared, and we found no matching FDA record
  • 22 No FDA claim, and we found no filing
# Mask FDA finding Price Amazon
1 SharkPick CryoGlow Sold by Amazon.com FDA records name it K242796, for wrinkles and acne $299 View on Amazon
4 CurrentBodyPick LED Light Therapy Mask Series 2 Sold by The Beauty Tech Group Ltd FDA records name it K250966, for wrinkles $469.99 View on Amazon
13 NEWKEY 4D LED Red Light Therapy Mask for Face Sold by NEWKEY Factory's filing lists its model K230351, for wrinkles and acne $159.99 View on Amazon
15 LifeProPick RevitaGlow Sold by Amazon.com Factory's filing lists its model K233114, for wrinkles and acne $149.99 View on Amazon
18 Therabody TheraFace Mask Glo Sold by TheraGun FDA records name it K230293, for wrinkles and acne FDA's device listing names the TheraFace Mask Glo under K230293, Therabody's own clearance. $299.99 Not linked
19 Ulike ReGlow Sold by Ulike Official US FDA records name it K243492, for wrinkles and acne $259 View on Amazon
25 Aphrona Moonlight LED Facial Mask Skin Care Mask Sold by Daman USA FDA records name it K192295, for acne Listed with FDA as "Aphrona LED facial mask" under K192295 by Beijing ADSS Development. $169.99 Unavailable today
35 Weltallina Red Light Therapy Mask for Face Sold by Weltallina Factory's filing lists its model K243978, for wrinkles and acne $53.99 View on Amazon
41 Jorking Red Light Therapy for Face Sold by Moonlit future store Factory's filing lists its model K253712, for wrinkles and acne $99.99 Unavailable today
42 CurrentBody LED Light Therapy Mask Series 1 Sold by LioSeller FDA records name it K221946, for wrinkles FDA's device listing names Currentbody under K221946, filed for CurrentBody's parent company; the Series 2 filing cites K221946 as its earlier mask. $259.99 Not linked
Show the other 8 masks with an FDA record tied to them
# Mask FDA finding Price Amazon
47 MEGELIN Led Red Light Therapy Face & Neck Mask Sold by Megelin Official US FDA records name it K252264, for wrinkles and acne $269 View on Amazon
48 Qure Q-Rejuvalight Pro Sold by Qure Skincare FDA records name it K230042, for wrinkles and acne $399 Not linked
52 BONLIBRO Red Light Therapy Mask for Face Sold by BONLIBRO Health · Amazon item B0H4GDDD9N Factory's filing lists its model K253054, for wrinkles and acne $69.99 View on Amazon
55 Omnilux Contour Face Sold by Posh Gifts Online FDA records name it K191629, for wrinkles Listed with FDA as "Omnilux Contour" under K191629 by I-SMART Development and The Beauty Tech Group. $442.99 View on Amazon
56 dreame Chrona Photon Sold by Dreame Technology HK Limited FDA records name it K253712, for wrinkles and acne Listed with FDA as "Dreame Chrona Photon Anti-Aging Skincare Mask (RB-053)" under K253712 by Dreame Trading. $209.99 View on Amazon
58 HigherDOSE Red Light Face Mask Sold by Prime Ledger Supply FDA records name it K241933, for wrinkles $269.99 Not linked
59 NOOANCE Elite X600 Sold by NOOĀNCE Paris FDA records name it K260150, for wrinkles Listed with FDA as "NOOANCE LED Facial Mask Elite X600 (MJ-66C)" under K260150 by Shenzhen Kaiyan, and NOOANCE's own filing lists that model. $749 View on Amazon
66 FOREO FAQ 202 Plus Sold by FOREO FDA records name it K240378, for wrinkles and acne Listed with FDA as "FAQ 202 Plus" under K240378 by FOREO. $879.99 View on Amazon
Show the 56 masks without one (including 16 possible matches we could not confirm)
# Mask FDA finding Price Amazon
2 INIA Red Light Therapy Mask for Face Sold by INIA Official US · Amazon item B0FLDP8Y5W No claim, none found $89.99 Not linked
3 INIA GLOW 4D Sold by INIA Official US Possible match, not confirmed K243040, for wrinkles and acne The seller's model number appears in a factory's filing, but nothing else ties the two, so we did not pick it. $199.99 View on Amazon
5 wavytalk Red Light Therapy Mask for Face Sold by wavytalk US Possible match, not confirmed K243555, for wrinkles and acne The seller's model number appears in a factory's filing, but nothing else ties the two, so we did not pick it. $109.99 View on Amazon
6 iRestore LED Face Mask Sold by iRESTORE Says FDA, none found iRestore's FDA clearances are for its hair-growth helmets. We found none for this face mask. $399 Not linked
7 MICEYLIVE Red Light Therapy for Face Sold by MALIONLAN Says FDA, none found The listing says FDA cleared. We found no filing that names the brand, and it shows no model or K number we could check. $94.99 Not linked
8 HIME SAMA LED Face Mask Sold by CL-Beauty No claim, none found $360 Not linked
9 Aimilove Red Light Therapy Mask for Face Sold by Yumustar Possible match, not confirmed K243423, for wrinkles and acne The seller's model number appears in a factory's filing, but nothing else ties the two, so we did not pick it. $79.99 View on Amazon
10 RENPHO Red Light Therapy Mask for Face Sold by Smartindex · Amazon item B0FJS8ZQWS Possible match, not confirmed K243555, for wrinkles and acne The seller's model number appears in a factory's filing, but nothing else ties the two, so we did not pick it. $169.99 View on Amazon
11 Aesthifae Red Light Therapy Mask for Face and Neck Sold by iFae Store Brand cleared, not this model K261407 Sold by the iFae store. FDA's device listing names iFae LED masks under K261407, but that filing lists other model numbers, so we could not confirm this one. $119.99 Not linked
12 Kelyoo Red Light Therapy for Face Mask Sold by Znxtop Possible match, not confirmed K213056, for wrinkles and acne The seller's model number appears in a factory's filing, but nothing else ties the two, so we did not pick it. $67.99 View on Amazon
14 Dr Dennis Gross DRx SpectraLite FaceWare Pro Sold by Dr. Dennis Gross Skincare, LLC Says FDA, none found The brand says FDA cleared but gives no K number. We found no filing that names Dr. Dennis Gross or this mask. $455 Not linked
16 Andalusite Red Light Therapy for Face Sold by VISDOCK No claim, none found $70.99 Unavailable today
17 IFAE Red Light Therapy Mask for Face and Neck Sold by inSkinBeauty · Amazon item B0GXGMJ6NM Brand cleared, not this model K261407 FDA's device listing names iFae LED masks under K261407, but that filing lists other model numbers, so we could not confirm this one. $149.98 Not linked
20 INIA Red Light Therapy Mask for Face Sold by INIA Official US · Amazon item B0F181GKGZ No claim, none found $179.99 Not linked
21 pedete Red Light Therapy Mask for Face Sold by Pedete Beauty No claim, none found $139.99 Not linked
22 XSSNVV Red Light Therapy Mask for Face Sold by XSSNVV GLOW No claim, none found $89.99 Not linked
23 RENPHO Red Light Therapy Mask for Face Sold by Smartindex · Amazon item B0H1GNQQSF No claim, none found $179.99 Not linked
24 Qynera Red Light Therapy for Face & Neck Sold by Yangtou Possible match, not confirmed K251667, for wrinkles and acne The seller's model number appears in a factory's filing, but nothing else ties the two, so we did not pick it. $109.99 View on Amazon
26 PRAVOLE Red Light Therapy Mask for Face Sold by King GLOW Possible match, not confirmed K251667, for wrinkles and acne The seller's model number appears in a factory's filing, but nothing else ties the two, so we did not pick it. $79.99 View on Amazon
27 Vital Vibes Red Light Therapy LED Face Mask + Collagen Sold by VITAL VIBES Says FDA, none found The listing says FDA cleared. We found no filing that names the brand, and it shows no model or K number we could check. $134.99 Not linked
28 INTEO Red Light Therapy Mask for Face Sold by INTEO-Smart No claim, none found $149.99 Not linked
29 Lunacyo Red Light Therapy Mask Face Sold by Lyntop No claim, none found $99.99 Not linked
30 SHMHE LED Face Mask Sold by SHMHE No claim, none found $26.99 Not linked
31 BONLIBRO Red Light Therapy Mask for Face Sold by BONLIBRO Health · Amazon item B0H6BV9PB5 Possible match, not confirmed K241857, for wrinkles and acne The brand gives this K number, but we could not confirm this exact mask is the one cleared, so we did not pick it. $69.99 View on Amazon
32 KNNKNN Red Light Therapy Mask for Face Sold by KNNKNN No claim, none found $59.99 Not linked
33 ONLUKY Red Light Therapy for Face Sold by ONLUKY Store No claim, none found $109.99 Not linked
34 Gleelar 3-in-1 LED Face Mask Sold by Woot Says FDA, none found The listing says FDA cleared. We found no filing that names the brand, and it shows no model or K number we could check. $119.99 Not linked
36 TOYHIS LED Face Mask Light Therapy Sold by TOYHIS US No claim, none found $29.99 Not linked
37 AAOCARE Hydraskincare Red Light Therapy for Face Sold by YANSU 2000 INC No claim, none found $197.99 Not linked
38 NOMADARA 3D Cordless Red Light Therapy Mask for Face Sold by Iceberg Toys Possible match, not confirmed K253712, for wrinkles and acne The brand gives this K number, but we could not confirm this exact mask is the one cleared, so we did not pick it. $199.99 Not linked
39 LuxRenew 4D Contour-Fit LED Light Therapy Mask for Face Sold by MusesNew No claim, none found $99.99 Not linked
40 EVFOFO Wireless Red Light Therapy Mask for Face Sold by ZHANHZ Store Possible match, not confirmed K253054, for wrinkles and acne The seller's model number appears in a factory's filing, but nothing else ties the two, so we did not pick it. $89.99 View on Amazon
43 SecretSky Red Light Therapy Mask for Face Sold by Woot No claim, none found $99.99 Unavailable today
44 biuufish Red Light Therapy Mask for Face and Neck Sold by YHDZ-US No claim, none found $139.98 Not linked
45 GYH 8-Color LED Face Mask Light Therapy Sold by GYH OFFICIAL STORE No claim, none found $360 Not linked
46 Aesthifae Red Light Therapy for Face Sold by iFae Store Brand cleared, not this model K261407 Sold by the iFae store. FDA's device listing names iFae LED masks under K261407, but that filing lists other model numbers, so we could not confirm this one. $79.99 Not linked
49 MEGELIN 7 Colors Led Light Therapy Facial Mask Sold by Megelin Official US Brand cleared, not this model K252264, for wrinkles and acne MEGELIN's clearance covers its JML masks. This 7-color mask is a different model, and the listing makes no FDA claim. $179 Not linked
50 SDKWDH Red Light Therapy for Face Sold by ZHANHZ Store Says FDA, none found The listing says FDA cleared. Its model name, M01, appears in three different companies' filings, so we could not tie it to one. $53.99 Not linked
51 Nanoleaf LED Light Therapy Face Mask Sold by Nanoleaf USA Brand cleared, not this model K243555 FDA's device listing names two Nanoleaf masks (models E43 and E105) under K243555. We could not confirm which model this listing is. $129.99 Not linked
53 AIHEU 3D Cordless Red Light Therapy Mask for Face Sold by Wellness-Mall No claim, none found $69.99 Not linked
54 CHCANYAOYU Wireless LED Light Therapy Mask Sold by riqigoyo No claim, none found $69.98 Not linked
57 IFAE Red Light Therapy Mask for Face and Neck Sold by inSkinBeauty · Amazon item B0FSSMBJ44 Brand cleared, not this model K261407 FDA's device listing names iFae LED masks under K261407, but that filing lists other model numbers, so we could not confirm this one. $149.99 Not linked
60 MICEYLIVE 4D Wireless Red Light Therapy Mask Sold by MINXINHOLDINGS Possible match, not confirmed K243555, for wrinkles and acne The seller's model number appears in a factory's filing, but nothing else ties the two, so we did not pick it. $199.99 View on Amazon
61 NOMADARA Red Light Therapy Mask for Face Sold by Iceberg Toys Possible match, not confirmed K253054, for wrinkles and acne The seller's model number appears in a factory's filing, but nothing else ties the two, so we did not pick it. $109.99 View on Amazon
62 Sojuvenver Red Light Therapy Mask for Face Sold by Sojuvenver-US Says FDA, none found The listing says FDA cleared. We found no filing that names the brand, and it shows no model or K number we could check. $129.98 Not linked
63 Deccasa 4 Light Red Light Face & Neck Mask Sold by Deccasa No claim, none found $59.99 Not linked
64 Ulike ReGlow Lite Sold by Ulike Official US Possible match, not confirmed K243555, for wrinkles and acne The seller's model number appears in a factory's filing, but nothing else ties the two, so we did not pick it. $75 View on Amazon
65 CoolPump Upgraded Red Light Therapy Mask for Face and Sold by CoolPump-US Possible match, not confirmed K253054, for wrinkles and acne The seller's model number appears in a factory's filing, but nothing else ties the two, so we did not pick it. $36.85 View on Amazon
67 Project E Beauty LumaLux Face Sold by Project E Beauty Brand cleared, not this model K214101, for wrinkles and acne Project E Beauty has clearances for other models. This mask's model, PE727, is not among them. $369 Not linked
68 LBO Red Light Therapy Mask for Face & Neck Sold by LBO-US Possible match, not confirmed K253054, for wrinkles and acne The seller's model number appears in a factory's filing, but nothing else ties the two, so we did not pick it. $49.98 Not linked
69 Zeepeak 3D Red Light Therapy for Face Sold by Zeepeak Says FDA, none found The listing says FDA cleared. We found no filing that names the brand, and it shows no model or K number we could check. $499.99 Not linked
70 Aiscool Red Light Therapy Mask for Face Sold by Yuwende Says FDA, none found The listing says FDA cleared. We found no filing that names the brand, and it shows no model or K number we could check. $129.99 Not linked
71 NEWKEY Blue Light Therapy Mask for Acne Sold by NEWKEY Possible match, not confirmed K220168, for wrinkles and acne The seller's model number appears in a factory's filing, but nothing else ties the two, so we did not pick it. $189.99 View on Amazon
72 Aureskyn Red Light Therapy for Face 4-Mode LED Mask Sold by Creative Living Shop Says FDA, none found The listing says FDA cleared but shows no K number or model number, so we could not tie it to a filing. $109.99 Not linked
73 Pure Daily Care Luma Mask Ultra LED Face & Neck Light Sold by Aquasonic Official No claim, none found $199.95 Not linked
74 EUARNE Red Light Therapy for Face Sold by EUARNE US Says FDA, none found The brand cites a K number that belongs to a different product. $129.99 Not linked

We link only in-stock masks whose FDA records name the mask or list its model. "Not linked" is not a safety finding; it means we could not confirm an FDA record for it. Cheaper masks that also pass our FDA test and are sold by the maker's own store: Weltallina Red Light Therapy Mask for Face (#35, $53.99) and BONLIBRO Red Light Therapy Mask for Face (#52, $69.99). They sell less than the LifePro, and our under-$150 pick is the best seller.

04 / Side by side

Our picks next to the big names

From each brand's own pages and FDA filings. "Measured" is from one independent reviewer's light meter; the Omnilux and HigherDOSE figures are worked out from the dose that reviewer measured.

Mask Amazon price Light Session FDA Measured output Warranty
SharkCryoGlowSold by Amazon.comView on Amazon $299 415, 630, 830 nm 6 min for lines; daily FDA records name it, wrinkles and acne Not tested 2 yr
CurrentBodyLED Light Therapy Mask Series 2Sold by The Beauty Tech Group LtdView on Amazon $469.99 633, 830 nm (filing); brand says it adds 1072 10 min FDA records name it, wrinkles 18.5 mW/cm² 2 yr
LifeProRevitaGlowSold by Amazon.comView on Amazon $149.99 415, 630, 830 nm (filing) 10 min (filing); listing says 15 to 20 Factory's filing lists its model, wrinkles and acne Not tested Not stated
OmniluxContour FaceSold by Posh Gifts OnlineView on Amazon $442.99 633, 830 nm 10 min FDA records name it, wrinkles 26.7 mW/cm² 2 yr
TherabodyTheraFace Mask GloSold by TheraGun $299.99 415, 633, 830 nm 12 min FDA records name it, wrinkles and acne Not tested 1 yr
HigherDOSERed Light Face MaskSold by Prime Ledger Supply $269.99 630, 830 nm 10 or 20 min FDA records name it, wrinkles 26 mW/cm² 1 yr

Choosing between the big names? Omnilux vs CurrentBody, compared: prices, FDA filings, measured light and CurrentBody's new Series 3. Dr. Dennis Gross vs Omnilux, compared: why we could not find the Dr. Dennis Gross mask's FDA record.

05 / What owners say

What owners complain about

From owners' own posts on Reddit, read October 5, 2026. This is not a survey: people with a problem post more, and some brands post too. Counts are the number of different owners who said it.

No owner reported burns or eye injuries for any of the three. A few reported redness or flaking; stop and see a dermatologist if that happens.

06 / Before you start

Who should check with a doctor first

Source: American Academy of Dermatology, "Is red light therapy right for your skin?"

07 / How we checked

74 masks, each matched against FDA's 510(k) database

On October 9, 2026 we pulled every LED face mask Amazon's product data returned for ten common searches ("red light therapy mask", "led face mask" and others), kept one row per mask (colors and sizes merged), and dropped 10 items that are not face masks (neck-only, hair helmets, wands, kits). Order is Amazon's own sales rank. We then searched FDA's 510(k) database for each mask's brand, product name and model number, read the filing, and checked FDA's device listings, where factories list the brand names they make each cleared mask for. A filing in a factory's name counts only when it lists the mask's exact model. Specs come from each brand's pages and filings. We did not test masks ourselves.

08 / Questions

Frequently asked

Do LED face masks actually work?
Yes, a little, if you use one for months. The American Academy of Dermatology says "some studies indicate" red light devices "can produce subtle to noticeable results on the face." The best evidence is for acne: a 2025 review in JAMA Dermatology found inflamed pimples dropped about 45 percentage points more with home LED devices than with a fake device or no treatment. For fine lines, a 16-week trial of a red and near-infrared mask found more improvement than a fake mask from week 8 on. Results take 4 to 12 weeks or more, and not everyone sees them.
What is the best red light therapy mask?
The Shark CryoGlow. FDA cleared it for wrinkles and acne under Shark's name, Amazon sells it, it has a 2-year warranty, and it is the best-selling LED face mask we found on Amazon. To spend more, the CurrentBody LED Light Therapy Mask Series 2. Under $150, the LifePro RevitaGlow.
Is the Shark CryoGlow FDA cleared?
Yes. FDA cleared it on November 27, 2024 under K242796, filed by SharkNinja itself. The clearance covers fine lines and wrinkles (red and infrared light) and mild to moderate inflammatory acne (red, blue and infrared light).
Is the CurrentBody LED mask FDA cleared?
Yes, for wrinkles only. The Series 2 mask was cleared on June 25, 2025 under K250966, filed by its maker, Shenzhen Kaiyan Medical Equipment. The filing covers red (633 nm) and near-infrared (830 nm) light and says "Clinical testing is not needed for this 510(k)." It has no acne clearance.
Is the Omnilux Contour FDA cleared?
Yes, for wrinkles. FDA's device listing names the Omnilux Contour under K191629, a 2019 clearance filed under the name "faceLITE." That clearance covers wrinkles, not acne.
Is the LifePro RevitaGlow FDA cleared?
Yes, through its factory. FDA cleared the factory's LED silicone mask under K233114 for acne and wrinkles, and FDA's device listing names RevitaGlow (model LP-RVTGLW-WHT) and RevitaGlow Pro under that number. LifePro's own name does not appear on the filing.
Are cheap LED masks from Amazon worth it?
Some are. Of the 21 masks whose specs we read, 17 use the same red and near-infrared colors, at prices from $89.99 to $749. What differs is how much light they put out, which is rarely tested, and whether anyone checked them. Of the 74 masks we checked, 18 have FDA records tied to that exact product, and 11 say "FDA" with no record we could match. The LifePro RevitaGlow ($149.99) is FDA cleared and sold by Amazon.
Is the Omnilux Contour worth it?
It has a good record: one independent reviewer measured strong output (about 26.7 mW/cm², worked out from the dose measured), and FDA's device listing names the Omnilux Contour under K191629. It is not our pick because on Amazon it is sold by a third-party store at $442.99, more than Omnilux's own $395 price.
What does "FDA cleared" mean for an LED mask?
It means FDA decided the mask is similar enough to one already sold, mostly on safety. It does not mean FDA tested whether it works. The FDA filing for CurrentBody's Series 2 says "Clinical testing is not needed for this 510(k)." Many masks are cleared under the factory's name, so the brand on the box may not appear on the filing. You can look up any K number in FDA's 510(k) database.
How often should I use an LED mask?
Follow the mask's directions. Most say 3 to 5 sessions a week of 6 to 20 minutes. The trials that found results ran 4 to 16 weeks, so plan on at least two to three months before you judge it.
Are LED masks safe for your eyes?
Use the eye protection your mask comes with and follow its directions. The dermatologists' group says not to use sunglasses in place of the goggles a device asks for. Talk to a doctor first if you have a light-sensitive condition such as lupus, take a medicine that makes you sensitive to light, or have a darker skin tone, which can be more sensitive to visible light.

09 / Sources

Sources, and when we checked them

  1. FDA 510(k) premarket notification database, each filing linked in the table, read October 9, 2026. accessdata.fda.gov
  2. Ershadi & Barbieri, at-home LED devices for acne, JAMA Dermatology 2025. PubMed 40042878
  3. Park et al., home LED mask for crow's feet, compared with a fake mask, Medicine 2025. PubMed 39960921
  4. Bragato et al., red light for facial wrinkles, Lasers in Medical Science 2025. PubMed 40167796
  5. American Academy of Dermatology, red light therapy. aad.org
  6. Measured output: lighttherapyinsiders.com spectrometer reviews (CurrentBody Series 2, Omnilux Contour, HigherDOSE). One tester, not a lab.
  7. Prices and sellers: amazon.com product data, October 9, 2026. Brand prices: omniluxled.com, sharkninja.com, currentbody.us, October 9, 2026.

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