We pulled the FDA record for 20 LED masks and beauty devices, from CurrentBody to Shark CryoGlow. 16 are cleared through a 510(k), none is approved, and 7 brand pages state specs that differ from their own 510(k) summary.
SlipperSkin finding
Of 20 LED masks and beauty devices checked against FDA records on 23 October 2026, 16 have a 510(k) clearance, none has PMA approval, and 7 brand pages state specs that differ from their own 510(k) summary; Medicube's AGE-R is listed as a Class I massager with no 510(k).
No, and that is normal: the ones that went through the FDA are cleared, not approved. Home LED masks for wrinkles and acne are Class II devices, which reach the market through a 510(k): the maker shows the FDA its device is substantially equivalent to one already on the market. Approval is a different route, premarket approval (PMA), for high-risk Class III devices. openFDA lists 163 clearances under the wrinkle code OHS and 51 under the acne code OLP, and no PMA under either.
In short:
Approval means the maker proved safety and effectiveness to the FDA; clearance means it proved substantial equivalence to an existing device. The FDA's consumer update puts it in three tiers: the highest-risk devices "generally require FDA approval of a premarket approval application"; moderate-risk devices are marketed through so-called "510(k) clearance"; and "Mere registration of an establishment or listing of a drug or device does not denote approval". Every clearance letter in this table also reminds the maker that "device labeling must be truthful and not misleading", and points to 21 CFR 807.97, under which a representation that creates "an impression of official approval" because of a 510(k) is misbranding.
So the fair reading is this. A clearance is not a rubber stamp: the maker filed bench, electrical and often clinical data, and the FDA agreed the device belongs with its predicate for a specific use. It is simply not an approval, and it covers only the indication on the letter.
Thirteen of the 20 devices are named in a 510(k) or in its listing, three sit under a clearance that does not name the model on sale, three had no FDA record naming them, and one is listed as Class I with no 510(k). The table puts the FDA's figures beside the brand's, so you can see where they agree, which is most of the time.
| Device | FDA status | K-number, date, code | Cleared indication | 510(k) summary: nm, LEDs, min | Brand page: nm, LEDs, min | Differs |
|---|---|---|---|---|---|---|
| CurrentBody Series 1 | 510(k), model not named | K221946, 2022-11-22, OHS | full-face wrinkles | 630, 830; 132; 10 | 633, 830; 132; 10 | none found summary describes model MK66R-B; listing names "Currentbody" |
| CurrentBody Series 2 | 510(k), names it | K250966, 2025-06-25, OHS | full-face wrinkles | 633, 830; 220; 10 | 633, 830, 1072; 236; 10 | 236 LEDs vs 220; adds 1072 nm listing places "Series 2" under K221946 |
| CurrentBody Series 3 | 510(k), names it | K260715, 2026-06-03, OHS | wrinkles (Mode 3), inflammatory acne (Mode 2), topical heating (Mode 1) | 415, 532, 590, 633, 830, 1072; 566; n/s | 415, 532, 590, 633, 830, 1072; 750; 10 | 750 LED bulbs vs 566 532 nm is "for user comfort and relaxation purposes only" |
| Omnilux Contour Face | 510(k), names it | K191629, 2019-09-12, OHS | full-face wrinkles | 630, 830; n/s; 10 | 633, 830; 132; 10 | none found cleared as "faceLITE"; listing names Omnilux Contour |
| DRx FaceWare Pro | no record found | K183247 (closest), 2019-03-14, OHS | closest record: wrinkles and mild to moderate inflammatory acne | 415, 605, 630, 660, 880; n/s; 3 | 415, 605, 630, 880; 160; 3 | none found page says FDA-cleared; no record names it; closest is dpl Faceware |
| Shark CryoGlow | 510(k), names it | K242796, 2024-11-27, OHS | fine lines and wrinkles; mild to moderate inflammatory acne | 415, 630, 830; 480; n/s | not stated; n/s; 8 | none found page gives no nm or LED count to compare |
| TheraFace Mask | 510(k), names it | K230293, 2023-06-09, OHS | full-face wrinkles (red); mild to moderate inflammatory acne (blue) | 415, 633, 830; 648; n/s | 415, 633, 830; 648; 9 | none found |
| TheraFace Mask Glo | 510(k), names it | K230293, 2023-06-09, OHS | as TheraFace Mask (same listing) | 415, 633, 830; 648; n/s | not stated; 504; n/s | 504 LEDs vs 648 listed under the TheraFace Mask clearance |
| Solawave Wrinkle Retreat Pro | 510(k), model not named | K221775, 2022-12-20, OHS | full-face wrinkles (acne for some models) | 415, 630, 830; n/s; 10 | 605, 630, 660, 830; 320; 3 | 605 and 660 nm; 3 min vs 10 listing names "Wrinkle Retreat", not "Pro"; no K-number on the page |
| Solawave wand | 510(k), names it | K232863, 2023-12-13, OHS | treating wrinkles on the face | 630; n/s; 3 | 630; 14; 3 | none found listing names "Solawave 4-in-1 Skincare Wand" |
| Silk'n LED Face Mask 100 | 510(k), names it | K223544, 2023-02-23, OHS | full-face wrinkles (red); inflammatory acne (blue); topical heating (infrared) | 460, 620, 850; n/s; 15 | 460, 620, 850; 100; 10 | 28.5 vs 9 to 12 mW/cm²; mode times swapped summary: manual 15 min, automatic 10; page: manual 10, automatic 15 |
| Hooga Luma | 510(k), model not named | K253712, 2026-01-23, OHS | full-face wrinkles; inflammatory acne; topical heating | 465, 630, 850; n/s; 10 | 465, 525, 630, 850; 280; 5 | adds 525 nm (disclosed); 5 min vs 10 Hooga cites the K-number; listing names Dreame and generic masks |
| Hooga original mask | no record found | none | no FDA claim made | n/a | 630, 660, 850; 66; 5 | none found sold without an FDA claim |
| LightStim for Wrinkles | 510(k), names it | K261482, 2026-07-31, OHS | full-face wrinkles | 605, 640, 652, 850; n/s; 3 | 605, 640, 652, 850; n/s; 3 | none found handheld; 3 minutes per area |
| HigherDOSE mask | 510(k), names it | K241933, 2024-09-27, OHS | full-face wrinkles | 630, 830; n/s; 10 | 630, 830; 132; 20 | 26/24 vs 20/30 mW/cm²; 20-min option both total 50 mW/cm² |
| Qure Q-Rejuvalight Pro | 510(k), names it | K230042, 2023-04-28, OHS | wrinkles and mild to moderate inflammatory acne | 415, 605, 630, 660, 880; n/s; 3 | 415, 605, 630, 660, 880; n/s; 3 | none found |
| MZ Skin LightMAX 2.0 | 510(k), names it | K213184, 2021-11-23, OLP | mild to moderate acne vulgaris; wrinkles | 415, 630, 830; n/s; 10 | 415, 633, 830; n/s; 10 | none found page: "one of the few FDA-cleared LED face masks" |
| Angela Caglia Crystal | 510(k), names it | K202390, 2021-07-14, OHS | wrinkles and/or mild to moderate acne | n/a | not stated | none found listed under the Aduro clearance; not on the brand store today |
| FOREO UFO 3 LED | no record found | none | no record found under FOREO | n/a | not stated | none found page: "Clinically proven to reduce wrinkles"; no FDA wording |
| Medicube AGE-R Booster Pro X2 | Class I listing only | ISA | Class I massager listing, no 510(k) | n/a | not stated | none found page makes no FDA claim |
Two patterns explain most of the gaps. First, masks are often made by an OEM that holds the clearance and lists many brands under it: in the FDA's listing database, K221775 carries 40 product names (Solawave Wrinkle Retreat, Bon Charge), K191629 carries 24 product names (Omnilux Contour, ELEMIS), K202390 carries 20 product names (Angela Caglia, Project E). That is legal and common, and it is why a brand's name may not appear on the 510(k) itself. Second, hardware moves faster than paperwork. A page that lists more LEDs or an extra wavelength may describe a newer version than the summary does, which is why we say "differs from", not "wrong". Scale matters for marketing lines too: MZ Skin's page calls its mask "one of the few FDA-cleared LED face masks", while openFDA lists 163 clearances under the wrinkle code alone, not all of them masks; its own clearance, K213184, is real.
On seven of the 20: CurrentBody Series 2, CurrentBody Series 3, TheraFace Mask Glo, Solawave Wrinkle Retreat Pro, Silk'n LED Face Mask 100, Hooga Luma and HigherDOSE mask. The differences are in wavelengths, LED counts, power and session length. Some favour the brand's reader: Hooga's page says outright that its 525 nm green mode "is not part of the FDA-cleared indications", the most candid line we found. And one gap closes on inspection: Silk'n's spec block lists both 10 and 15 minutes because it has two modes, as does its summary, though the page pairs them the other way round.
Three had no FDA record naming them, and one is listed as a Class I device. Dr. Dennis Gross's FaceWare Pro page says "This device is FDA Cleared!", but no 510(k) or listing names it; the closest record is LED Technologies' "dpl Faceware" (K183247), and the brand may know the number we could not find. FOREO's UFO 3 LED page says it is "Clinically proven to reduce wrinkles" without FDA wording, and we found no FOREO clearance for it, though FOREO does hold OHS clearances for other devices. Hooga's original mask makes no FDA claim at all, which is the honest way to sell one. Medicube's AGE-R Booster Pro range is listed under product code ISA, "Massager, Therapeutic, Electric", Class I, with no K-number; its page makes no FDA claim either.
The microcurrent side of the aisle is mostly cleared under code NFO; see the best microcurrent device for those records, and the best LED face mask for prices.
Find the K-number, open the record, read the indication, then compare the summary to the box. It takes five minutes on the FDA's 510(k) database, and the summary PDF is linked from each record.
1. Look for the word: "cleared" is the usual one. "Approved" would mean a PMA. We found none. 2. Find the K-number (K + six digits). Search accessdata.fda.gov 510(k) by brand if needed. 3. Open the record: is your brand or model named? One maker's clearance often covers many brands. 4. Read the indication: wrinkles, acne, heating. Nothing else is cleared. 5. Open the 510(k) summary PDF. Compare wavelengths, LED count and session minutes. 6. If they differ, ask the brand which K-number covers the version on sale.
Choosing an app instead of a device? Start with how accurate AI skin analysis apps are, and see which device apps collect what in LED mask apps compared.
On 23 October 2026 we queried openFDA's 510(k), PMA, classification and registration and listing endpoints (data last updated 12 October 2026) for every brand and model named here, downloaded each FDA-hosted 510(k) summary PDF and read the subject-device column of its comparison table. Where a summary gives two values for one spec, we say so. Brand pages were read the same day. Several Shopify stores refused automated reads (HTTP 429) on the first pass and were read on retry the same day. "Differs" means a stated page figure is outside the summary's figure or tolerance; it is not a finding that a page is false, and a summary can predate the hardware on sale. Nothing here is a verdict on whether any device works or is safe.
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None that we found. Of 20 devices checked on 23 October 2026, 16 have a 510(k) clearance and none has premarket approval (PMA). openFDA shows no PMA under the wrinkle (OHS) or acne (OLP) codes. "Cleared" is the accurate word.
The maker filed a 510(k) and the FDA found the mask substantially equivalent to a device already on the market, for a stated indication such as full-face wrinkles or mild to moderate inflammatory acne. It is a real review, but not an approval, and it covers only that indication.
Look for a K-number on the page or box and enter it in the FDA 510(k) database at accessdata.fda.gov. If there is none, search by brand; if that fails, the Registration and Listing database shows which clearance a brand name is listed under.
Because many masks are made by an OEM that holds the clearance. In the FDA's listing data, K221775 carries 40 product names and K191629 carries 24, including Omnilux Contour. A brand can lawfully sell under the maker's clearance.
We found no 510(k). The FDA listing places the AGE-R Booster Pro range under product code ISA, "Massager, Therapeutic, Electric", a Class I code, with no K-number. Medicube's own page makes no FDA claim.
Yes. K242796, decided 27 November 2024 to SharkNinja, covers fine lines and wrinkles and mild to moderate inflammatory acne. Its summary lists 415, 630 and 830 nm and 480 LEDs; the Shark page gives session times but no wavelengths.
LED masks are cleared, not approved, and most of the ones checked here are cleared for exactly what they say. Find the K-number, read the indication, and if the box does not match the summary, ask the brand which clearance covers the version you are buying.