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 2026-09-24.

The NuFACE Trinity+ costs $395.00 and its model is named in a 510(k) record (K201782); the FOREO BEAR 2 costs $283.99 and no 510(k) record names it. 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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Side by side

	FOREO BEAR 2	NuFACE Trinity+
Price (Amazon US, 2026-09-24)	$283.99	$395.00
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 →	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.

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 owning one costs

The device is only the first cost: see the ownership-cost page for the gel and serum each one needs, with a calculator.

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.