Is the FOREO BEAR 2 or the NuFACE Trinity+ FDA cleared?

A 510(k) record names the NuFACE Trinity+ (K201782, held by Carol Cole Company Dba Nuface, 2021-01-22). No 510(k) record names the FOREO BEAR 2 face device; FOREO's K200803 names “BEAR and BEAR mini” and K232242 names “BEAR 2 Body”. A 510(k) is a safety and substantial-equivalence review, not FDA approval and not evidence of results.

FOREO BEAR 2 vs NuFACE Trinity+

Last checked 2026-10-02.

A 510(k) record names the NuFACE Trinity+ (K201782); no 510(k) record names the FOREO BEAR 2. Both makers' instructions call for a conductive gel or serum on the skin at every session, and the BEAR 2 must be unlocked in FOREO's app before first use. Everything below is from the listing, the manufacturer's own page or manual, or the FDA's database, each linked or named.

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Links that say “Buy from FOREO” go to FOREO's own store through the Awin affiliate network, and BeautyEvidence may earn a commission on purchases there too, at no extra cost to you. Each opens that model's page on foreo.com, where the sets on offer can differ from the Amazon listing this page describes.

Side by side

	FOREO BEAR 2	NuFACE Trinity+
510(k) record	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	K201782 “NuFace Trinity Plus Device”, held by Carol Cole Company Dba Nuface, decided 2021-01-22
Brand's own claim	the product listing does not state an FDA clearance	NuFACE markets it as “FDA cleared”
Required consumable	conductive serum — FOREO's BEAR 2 manual: “Microcurrent devices like BEAR™ 2 must be used with a conductive serum”	activator gel — NuFACE's product page: “Apply a mask-like layer of Microcurrent Activator to your treatment area”
In the box	none stated in the listing title	Activator gel (per the Amazon listing title)
App	required before first use: “download the FOREO For You mobile app to unlock and register your device” (FOREO manual)	not stated as required on NuFACE's product page
Warranty	2-year warranty; 3 years in Spain, Portugal and Sweden (FOREO product page)	2-year warranty (NuFACE product page)
Seller	Sold by FOREO, ships from Amazon	Sold by Front Row Group, ships from Amazon
Buy	Amazon → Buy from FOREO →	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; sellers and box contents are from the Amazon US listings and the consumable rules from each maker's manual or product page, all read 2026-10-02, except the consumable packs, which carry their own read dates. Anything no source states is marked as not stated. No prices are shown: check the retailer for the current price.

What the clearance difference does and does not mean

A 510(k) clearance means the FDA found a device substantially equivalent to one already on the market, for its stated use. It is a safety-and-equivalence review: it does not show that a device works, or works better than another. FOREO does hold clearance K200803 for “BEAR and BEAR mini”, the earlier model, and “BEAR 2 Body” (K232242); neither names the BEAR 2 face device, so we do not call it cleared. More on each model on the clearance page.

What else you need

Each one needs a gel or serum at every session: see the ownership page for the gel or serum each device needs, with a calculator for your own prices.

We did not test any device here, and nothing on this page is medical advice or a result claim. Read each manufacturer's instructions and warnings before use.