FDA Cleared Microcurrent Devices, How to Check Any Claim
Medically reviewed by
4 independent reviewers
Andrew Conrad Barile, kinésithérapeute, DPT
Doctorat en physiothérapie (DPT), physiothérapeute agréé (PT)
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Le Dr Andrew Conrad Barile est docteur en physiothérapie et PDG ainsi que fondateur de Xtreem Pulse LLC. Il a obtenu son doctorat en physiothérapie à Daemen College et possède plus de vingt ans d'expérience clinique et entrepreneuriale en physiothérapie pédiatrique, thérapie craniosacrale et innovation en dispositifs médicaux. Sa profonde connaissance de l'anatomie humaine, de la physiologie musculaire et des technologies thérapeutiques offre une approche scientifique précieuse pour le rajeunissement du visage et les solutions anti-âge.
Bertica M. Rubio, M.D.
Directeur Médical, Clinique de Médecine Régénérative Anti-âge | Médecin Certifié par le Conseil | École de Médecine de Dartmouth
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Le Dr Bertica M. Rubio est une médecin certifiée et directrice médicale de la clinique de médecine régénérative anti-âge à Redlands, en Californie. Elle a obtenu son Bachelor of Science à l'Université Loyola Marymount et son Doctorat en médecine à la Dartmouth Medical School (Geisel School of Medicine). Elle a effectué sa résidence en pédiatrie au UC Irvine Medical Center.
Forte de plusieurs décennies d'expérience clinique, le Dr Rubio est spécialisée en médecine de gestion du vieillissement, médecine régénérative, cicatrisation des plaies et thérapies par facteurs de croissance. Sa pratique intègre la science médicale fondée sur des preuves avec des traitements esthétiques et régénératifs avancés, aidant les patients à atteindre une santé optimale et une vitalité juvénile.
Le Dr Rubio est passionnée par l'éducation des patients sur la science derrière les soins de la peau, le rajeunissement du visage et les technologies non invasives comme l'EMS (stimulation électrique musculaire) pour le tonus facial. Ses articles pour PureLift LAB allient connaissances médicales rigoureuses et conseils pratiques pour obtenir des résultats réels et durables.
Daniel Grinberg, MD, FACS
Otolaryngologiste et chirurgien de la tête et du cou certifié par le conseil | Membre, American College of Surgeons | Professeur clinique adjoint, Mount Sinai School of Medicine
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Daniel Grinberg, MD, FACS, est un oto-rhino-laryngologiste certifié par le conseil et chirurgien de la tête et du cou chez ENT and Allergy Associates à West Nyack, NY. Il a obtenu son diplôme de médecine au Columbia University College of Physicians and Surgeons, a effectué sa résidence en oto-rhino-laryngologie au New York University Medical Center, et est professeur clinique adjoint à la Mount Sinai School of Medicine. Il est membre de l'American College of Surgeons et de l'American Academy of Otolaryngology.
La perspective chirurgicale de la tête et du cou du Dr Grinberg offre aux lecteurs de PureLift LAB une vision clinique élargie — reliant la pratique EMS à domicile à l'anatomie médicale sous-jacente avec la même rigueur scientifique que celle que nous appliquons à chaque spécification d'appareil.
Prof. Dr med Ivo Buschmann
Président d'Angiologie, Hochschule Medizinische Brandenburg | Directeur de clinique, Clinique universitaire d'angiologie, Hôpital universitaire de Brandebourg | Ancien consultant principal, Charité Universitätsmedizin Berlin
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Le Prof. Dr. med. Ivo Buschmann est titulaire de la chaire d'angiologie à la Medizinische Hochschule Brandenburg Theodor Fontane (MHB) et directeur de la clinique universitaire d'angiologie à l'hôpital universitaire de Brandebourg. Il a effectué sa formation médicale à l'Université de Hambourg, a été boursier de la Société Max-Planck à l'Institut Max-Planck de recherche sur le cœur et les poumons, et a occupé des postes de consultant principal à la Charité Universitätsmedizin Berlin Campus Virchow avant d'être nommé titulaire de la chaire à la MHB en 2016.
Le Prof. Buschmann est l'une des principales autorités européennes en arteriogenèse — la croissance et le remodelage des vaisseaux sanguins induits par le flux — avec plus de 150 publications évaluées par des pairs et plusieurs brevets américains et européens sur des dispositifs stimulant la croissance des vaisseaux collatéraux par une thérapie contrôlée du taux de cisaillement. Ses recherches relient la stimulation mécanique et électrique à l'adaptation vasculaire, à la microcirculation et à la perfusion tissulaire.
Les contributions du Prof. Buschmann apportent aux lecteurs de PureLift LAB une perspective en biologie vasculaire qui complète notre expertise clinique, en physiothérapie et en anatomie chirurgicale — expliquant comment la stimulation EMS engage non seulement les muscles faciaux mais aussi la microcirculation qui les alimente, et pourquoi une administration intelligente est aussi importante au niveau du flux sanguin qu'à celui de la contraction musculaire.
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Most brands using FDA language in this category do hold a clearance, the numbers are public, and a clearance says far less about whether a device works than the badge implies.
This article sets out what to check before you start, such as:
- the K numbers behind the main microcurrent brands
- what product code NFO actually covers
- the difference between cleared, approved and registered
- where a clearance sits with a manufacturer rather than a brand
- the two-minute check you can run on any device
and many more!
Every number below can be typed into the FDA's own database and checked against what we have written.
Key Points:
Cleared means a 510(k) was submitted and the FDA agreed the device is substantially equivalent to one already on the market.
Approved is a different and heavier pathway, and no at-home facial device goes through it, ours included.
Registered means a factory is on a list, which says nothing about the device itself.
Most facial microcurrent devices are cleared under product code NFO, a transcutaneous electrical stimulator for aesthetic purposes.
Clearances commonly sit with the contract manufacturer rather than the brand on the box, which is normal and traceable.
The numbers, brand by brand
NuFACE holds a substantial family of clearances, including K201680 for the MINI+, K201782 and K212947 associated with the Trinity line, and K191672 for the earlier Mini.
ZIIP's Halo is associated with K212342, and FOREO holds K200803 for BEAR and BEAR mini along with K232242 for BEAR 2 Body.
Therabody's TheraFace PRO is cleared under K212238, and the TheraFace Mask under K230293.
Solawave's Radiant Renewal Wand is cleared under K232863, held by its manufacturer Shenzhen Kaiyan, with later records under Shenzhen Nuon covering the microcurrent function.
7E Wellness has K213078 for the MyoLift QT, filed by Johari Digital Healthcare in India, and Ya-Man holds K220198 for the Medi Lift PLUS.
PureLift devices are cleared under K190269 for Face, K230506 for Pro and Pro Edition, K221443 for Pro Plus and K243587 for GLOW.
What the clearance actually permits
Most of these sit under product code NFO, a transcutaneous electrical stimulator for aesthetic purposes, regulated as Class II.
The indications for use on these records are typically a single sentence along the lines of facial stimulation for over-the-counter cosmetic use, and that sentence is the entire scope of what was cleared.
Nothing about collagen synthesis, ATP production, jawline lifting or wrinkle reduction appears in those indications, so a brand using a clearance to imply endorsement of a biological claim is stretching the document.
Ya-Man's record is a clean example, with the indication stated simply as facial stimulation indicated for over-the-counter cosmetic use.
Three words that are not synonyms
Cleared means a 510(k) was reviewed and the device was found substantially equivalent to a predicate already on the market. There is a K number and you can read the file.
Approved means premarket approval, a far heavier process reserved for higher-risk devices such as implants. No at-home facial device has it, and any brand using the word is using the wrong one.
Registered means the manufacturer has told the FDA where its factory is. It is an address on a list and carries no judgement about the device.
We found one brand in this category describing its device as FDA approved on its own product page while carrying a registered-manufacturer badge in the footer, which is two different errors in the same shop.
Where the clearance sits
A clearance is often held by the factory rather than the brand you are buying from, which is entirely normal in consumer electronics and not a warning sign.
Solawave's sits with Shenzhen Kaiyan, 7E's with Johari Digital Healthcare in India, HigherDOSE's with Shenzhen Kaiyan as well.
That is worth knowing for a different reason: it tells you where the device is actually made, which almost no brand in this category publishes on its own page.
PureLift devices are made in Japan in an ISO 13485 facility that has been building medical devices since 1987, and we print that rather than leaving you to infer it from a filing.
The two-minute check
Open the FDA's 510(k) database at accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm.
Search the brand name in Applicant Name first, then the device name in Device Name, because the record may sit with the manufacturer.
Check that the record names the model you are buying rather than an earlier one, since a clearance for last year's device does not automatically cover this year's.
Read the indications for use, which is usually one sentence, and compare it with what the product page is claiming.
We have written the longer version of this as a full guide to running the check, including what a 510(k) Summary gives you that a Statement does not.
What a clearance does not tell you
It does not tell you the device works, because substantial equivalence is a comparison with an older device rather than a finding of benefit.
It does not tell you the output, unless the manufacturer filed a Summary rather than a Statement, and many of the most useful numbers in this category are only available because someone did.
It does not tell you whether the device is right for you medically, which is a conversation with your own doctor, particularly if you have an implanted electronic device.
What it does tell you is that a manufacturer went through a process and put its device on a public record, which is worth more than a badge with no number behind it.
This article sits inside our full map of the category, where we set out all 33 devices we track, what each one carries and what each brand publishes: Nine Technologies on One Dial, What the Rest of the Market Actually Carries.