Microcurrent devices and the FDA record, model by model
Last checked 2026-09-24.
Of five current NuFACE and FOREO microcurrent devices, a 510(k) record names 2 of them: the NuFACE Trinity+ (K201782) and the FOREO BEAR mini (K200803). The other three sell under names no 510(k) record carries, even where the brand holds clearances for earlier or related models. This page shows each match and near-miss, linked to the FDA database.
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What the record covers
These devices are cleared, where they are, under product code NFO, “Stimulator, Transcutaneous Electrical, Aesthetic Purposes”, a Class II device under 21 CFR 882.5890. A 510(k) clearance is a safety and substantial-equivalence review against a device already on the market. It is not FDA approval, not an endorsement, and not evidence that a device lifts, tones or works better than another. A device that is only registered or listed with the FDA has not been reviewed at all.
| Device | The brand's claim | 510(k) record (openFDA, 2026-09-24) | Price |
|---|---|---|---|
| NuFACE Trinity+ Starter Kit | NuFACE markets it as “FDA cleared” | K201782 “NuFace Trinity Plus Device”, held by Carol Cole Company Dba Nuface, decided 2021-01-22 | $395.00 Amazon → |
| NuFACE MINI+ Starter Kit | NuFACE markets it as “FDA cleared” | no 510(k) names this model; nearest record: K191672 “NuFACE Mini Device” (2019-10-15), held by Carol Cole Company Dba Nuface | $250.00 Amazon → |
| FOREO BEAR 2 | the product listing does not state an FDA clearance | no 510(k) names this model; nearest record: K200803 “BEAR and BEAR mini” (2020-07-31) and K232242 “BEAR 2 Body” (2024-05-13), both held by Foreo, Inc.; neither names the BEAR 2 face device | $283.99 Amazon → |
| FOREO BEAR 2 go | the product listing does not state an FDA clearance | no 510(k) names this model; nearest record: no 510(k) under a BEAR 2 go name; see BEAR 2 | $139.99 Amazon → |
| FOREO BEAR mini + SUPERCHARGED Serum 2.0 (1 fl oz) set | the product listing does not state an FDA clearance | K200803 “BEAR and BEAR mini”, held by Foreo, Inc., decided 2020-07-31 | $149.99 Amazon → |
Kinds of claim on this page: the 510(k) rows are product evidence from the FDA database; the brands' statements are manufacturer claims, quoted; prices, sellers and box contents are from the Amazon US listings and the consumable rules from each maker's manual or product page, all read 2026-09-24. Anything no source states is marked as not stated.
Why a brand's clearance does not transfer to every model
A clearance names the device, or devices, it was granted for. NuFACE's 2019 clearance names the “NuFACE Mini Device”; NuFACE markets the MINI+ as FDA cleared, but no record we found carries the MINI+ name, so we do not match it ourselves. FOREO's K200803 names “BEAR and BEAR mini”, and K232242 names “BEAR 2 Body”; neither names the BEAR 2 or BEAR 2 go face devices. A model can be a close successor of a cleared one; the record simply does not say so, and neither do we.
Before you buy
- Every one of these is meant to be used with a conductive gel or serum, per its maker's instructions: see what that costs.
- The FOREO devices must be unlocked in the FOREO For You app before first use, per FOREO's manuals.
- Read the manufacturer's warnings before use: FOREO's BEAR 2 manual, for example, says not to use the device with any implanted medical device, and that its safety during pregnancy has not been established.
We test nothing and give no medical advice. The claim, the record and the link are here so you can read the paper yourself.