NuFACE, ZIIP, FOREO, Solawave and TheraFace are cleared through a 510(k) for facial (and mostly neck) stimulation; Medicube's AGE-R is listed as a Class I massager. 8 devices from $169 to $419.99, with the indication each one actually carries.
SlipperSkin finding
Of 8 microcurrent devices checked against FDA records on 23 October 2026, 7 have a 510(k), every one cleared only for facial (and in 5 cases neck) stimulation for cosmetic use; none of the indications mentions lifting or toning, and Medicube's AGE-R is listed as a Class I massager.
A cleared one at the price and size you will actually use, because the clearances are all but identical. Every microcurrent clearance here sits under the same product code, NFO, and reads "facial and neck stimulation" (or facial only) for over-the-counter cosmetic use. What separates them is price, attachments, an app and the claims on the box, not the indication.
In short:
On price they run from $169 to $419.99, with a median of $322.50; on clearance they barely differ. The table quotes each indication word for word.
| Device | Price | FDA record | Cleared indication (quoted) | App, rating | On the brand page |
|---|---|---|---|---|---|
| NuFACE TRINITY+ | $395 | K201782, 2021-01-22 LED: K212947 | intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use | none found | "Lift, define, and visibly tone 69 muscles"; 91% from a consumer questionnaire 15 minutes after use |
| NuFACE MINI+ | $250 | K201680, 2021-02-19 | intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use max output 335 µA (summary) | none found | starter kit currently bundles a FIX MicroWand |
| NuFACE FIX MicroWand | $175 | K240564, 2024-06-27 | intended for facial stimulation and is indicated for over-the-counter cosmetic use max output 225 µA (summary) | none found | listed by the FDA as "FIX MicroWand (FIX+)" |
| ZIIP HALO | $399.99 | K212342, 2021-09-23 | intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use | ZIIP Beauty, 2.5 from 144 | no FDA wording; treatments beyond the built-in 4 Minute Facial need the app; 2-year warranty |
| FOREO BEAR 2 | $399 | K200803, 2020-07-31 | intended for facial and neck stimulation and are indicated for over-the-counter cosmetic use | FOREO For You, 4.8 from 2,213 | "alternative to surgery"; "up to 680 uA"; wrinkles "in just 1 week" |
| Solawave 4-in-1 wand | $169 | K232863, 2023-12-13 | intended for facial and neck stimulation ... the red light is intended for treating wrinkles on the face | none found | calls its current "Galvanic Current"; the clearance describes "micro current stimulation" |
| TheraFace PRO | $419.99 read earlier 23 Oct | K212238, 2021-09-29 LED: K212155 | for over-the-counter aesthetic purposes ... indicated for facial stimulation | Therabody, 4.7 from 7,794 | microcurrent is an attachment; a Microcurrent Ring sells alone for $149.99 |
| Medicube AGE-R Booster Pro X2 | $249 | Class I listing, ISA | no 510(k): listed as a Class I massager (ISA) | AGE-R medicube, 4.3 from 325 | an "MC Mode" the page does not spell out; no FDA claim |
Stimulation of the face, and sometimes the neck, for cosmetic use. That is the whole indication on every NFO clearance in this aisle. It does not say lift, tone, contour or wrinkle reduction; where a wrinkle indication appears, it belongs to a red-light mode, as on Solawave's wand. Solawave's own page, incidentally, describes the wand's current as "Galvanic Current", while its 510(k) summary (model HD-15A) describes "micro current stimulation of the face and neck". Brand pages go further in their own words: NuFACE says TRINITY+ can "lift, define, and visibly tone 69 muscles", and FOREO calls BEAR 2 a "safe, painless, non-invasive alternative to surgery". Those are marketing claims under the brand's name, not part of the clearance.
Medicube is the outlier. Its AGE-R Booster Pro range is listed with the FDA under product code ISA, "Massager, Therapeutic, Electric", Class I, with no 510(k). Its page lists an "MC Mode" among seven modes without spelling it out, and makes no FDA claim, so this is a data point about the listing rather than a fault on the page. For the LED side of the same question, see are LED face masks FDA approved?
The independent evidence is thin. A 2024 review in Clinical, Cosmetic and Investigational Dermatology, Bu et al., gathered 18 clinical studies of home radiofrequency, microcurrent and LED devices for facial ageing and concluded they "can improve skin aging to a certain extent", while noting small samples, short follow-up and limited research overall; its abstract does not separate microcurrent from the other technologies. The larger 2021 review of home devices by Cohen et al. covered light, laser, radiofrequency and UVB devices, and did not include microcurrent at all.
Brands' own figures fill the gap and should be read as such. NuFACE's 91% "saw improved cheek contour" comes, by its own footnote, from "a consumer post-treatment questionnaire 15 minutes post-treatment". FOREO says BEAR 2 is "clinically proven to significantly improve wrinkles" in one week, and that 95% of users report looking younger. ZIIP cites a 2023 SGS study, 28% less visible forehead wrinkles after 42 days, which its page sizes at 31 adults in one place and 32 subjects in another. Medicube cites a 36.1% drop in forehead lines from a "Global Institute of Dermatological Sciences" trial. None of these is linked to a published paper on the page.
1. K-number: is the model named on the FDA record? Code NFO is the microcurrent one. 2. Indication: "facial and neck stimulation" for cosmetic use. That is the whole clearance. 3. Claims: lift, tone, contour and "alternative to surgery" are the brand's words, not the FDA's. 4. Gel: most need a conductive gel; count it in the running cost. 5. App: optional for most. Read its privacy label before you sign in.
For the masks, see the best LED face mask; for what device apps collect, LED mask apps compared; and for how far phone skin scans can be trusted, how accurate AI skin analysis apps are.
On 23 October 2026 we read each device's 510(k) record and summary PDF through openFDA and the FDA's document server, and the FDA's registration and listing data for which brand names sit under which clearance. Prices are each brand's US list price that day; Therabody's TheraFace PRO price could not be re-read later the same day, so it is from an earlier read and marked. App ratings come from Apple's lookup service the same day. Output currents are quoted only where a summary states them. Nothing here is our verdict on whether a device works; the evidence section reports published reviews.
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Yes. TRINITY+ is cleared under K201782 (January 2021), MINI+ under K201680 and FIX MicroWand under K240564, all for facial (and, for TRINITY+ and MINI+, neck) stimulation for over-the-counter cosmetic use. The TRINITY+ Wrinkle Reducer attachment has its own LED clearance, K212947.
We found no 510(k). The FDA listing places the AGE-R Booster Pro range under code ISA, a Class I therapeutic massager, with no K-number. Medicube's page makes no FDA claim.
The FDA found it substantially equivalent to an existing device under code NFO, for facial (and often neck) stimulation for cosmetic use. The clearance does not cover lifting, toning or wrinkle reduction; those are brand claims.
Yes. The FDA listing names Bear 2 under K200803, the BEAR and BEAR mini clearance of July 2020, indicated for facial and neck stimulation for over-the-counter cosmetic use.
The independent evidence is thin. A 2024 review of 18 studies of home RF, microcurrent and LED devices found some improvement in skin ageing but small samples and short follow-up. Most figures on brand pages are the brands' own, often consumer questionnaires.
By App Store rating on 23 October 2026: FOREO For You, 4.8 from 2,213 ratings, then Therabody, 4.7 from 7,794. ZIIP Beauty rated 2.5 from 144. NuFACE and Solawave have no app we could find.
Most microcurrent devices here are cleared, and cleared for the same modest thing: facial stimulation for cosmetic use. Choose on price, size and whether you want an app, and read lift and contour claims as the brand's, not the FDA's.