FDA Cleared Microcurrent Devices, How to Check Any Claim
Medically reviewed by
4 independent reviewers
Andrew Conrad Barile, Physiotherapeut, Doktor der Physiotherapie
Doktor der Physiotherapie (DPT), Lizenzierter Physiotherapeut (PT)
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Dr. Andrew Conrad Barile ist Doktor der Physiotherapie sowie CEO und Gründer von Xtreem Pulse LLC. Er erwarb seinen Doktortitel in Physiotherapie am Daemen College und bringt über zwei Jahrzehnte klinische und unternehmerische Erfahrung in der pädiatrischen Physiotherapie, Craniosacraltherapie und medizinischen Geräteinnovation mit. Sein tiefes Verständnis der menschlichen Anatomie, Muskelphysiologie und therapeutischen Technologie bietet einen wissenschaftlich fundierten Ansatz für Gesichtsverjüngung und Anti-Aging-Lösungen.
Bertica M. Rubio, M.D.
Medizinischer Direktor, Anti-Aging-Regenerationsmedizinische Klinik | Facharzt | Dartmouth Medical School
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Dr. Bertica M. Rubio ist eine zertifizierte Ärztin und medizinische Leiterin der Anti-Aging-Regenerationsklinik in Redlands, Kalifornien. Sie erwarb ihren Bachelor of Science an der Loyola Marymount University und ihren Doktortitel in Medizin an der Dartmouth Medical School (Geisel School of Medicine). Ihre Facharztausbildung in Pädiatrie absolvierte sie am UC Irvine Medical Center.
Mit jahrzehntelanger klinischer Erfahrung spezialisiert sich Dr. Rubio auf Altersmanagement, regenerative Medizin, Wundheilung und Wachstumsfaktor-Therapien. Ihre Praxis verbindet evidenzbasierte medizinische Wissenschaft mit fortschrittlichen ästhetischen und regenerativen Behandlungen, um Patienten zu optimaler Gesundheit und jugendlicher Vitalität zu verhelfen.
Dr. Rubio ist leidenschaftlich daran interessiert, Patienten über die Wissenschaft hinter Hautpflege, Gesichtsverjüngung und nicht-invasiven Technologien wie EMS (Elektrische Muskelstimulation) zur Gesichtstonung aufzuklären. Ihre Artikel für PureLift LAB verbinden fundiertes medizinisches Wissen mit praktischen Anleitungen für echte, nachhaltige Ergebnisse.
Daniel Grinberg, MD, FACS
Facharzt für Hals-Nasen-Ohren-Heilkunde und Kopf-Hals-Chirurgie | Fellow des American College of Surgeons | Assistenz-Professor für Klinische Medizin, Mount Sinai School of Medicine
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Daniel Grinberg, MD, FACS, ist ein von der Ärztekammer zertifizierter Hals-Nasen-Ohren-Arzt und Kopf-Hals-Chirurg bei ENT and Allergy Associates in West Nyack, NY. Er erwarb seinen medizinischen Abschluss an der Columbia University College of Physicians and Surgeons, absolvierte seine Facharztausbildung in Hals-Nasen-Ohren-Heilkunde am New York University Medical Center und ist Assistenzprofessor an der Mount Sinai School of Medicine. Er ist Fellow sowohl des American College of Surgeons als auch der American Academy of Otolaryngology.
Dr. Grinbergs Perspektive als Kopf-Hals-Chirurg bietet den Lesern von PureLift LAB eine erweiterte klinische Sichtweise — er verbindet die EMS-Anwendung zu Hause mit der zugrunde liegenden medizinischen Anatomie mit derselben wissenschaftlichen Genauigkeit, die wir auf jede Gerätespezifikation anwenden.
Prof. Dr. med. Ivo Buschmann
Lehrstuhl für Angiologie, Medizinische Hochschule Brandenburg | Klinikdirektor, Universitätsklinik für Angiologie, Brandenburgisches Klinikum | Ehemaliger Oberarzt, Charité Universitätsmedizin Berlin
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Prof. Dr. med. Ivo Buschmann ist Lehrstuhlinhaber für Angiologie an der Medizinischen Hochschule Brandenburg Theodor Fontane (MHB) und Klinikdirektor der Universitätsklinik für Angiologie am Brandenburgischen Universitätsklinikum. Er absolvierte seine medizinische Ausbildung an der Universität Hamburg, war Max-Planck-Gesellschaft-Stipendiat am Max-Planck-Institut für Herz- und Lungenforschung und hatte leitende Oberarztpositionen an der Charité Universitätsmedizin Berlin Campus Virchow inne, bevor er 2016 zum Lehrstuhlinhaber an der MHB berufen wurde.
Prof. Buschmann ist einer der führenden europäischen Experten für Arteriogenese – das durch Fluss angetriebene Wachstum und die Umgestaltung von Blutgefäßen – mit mehr als 150 begutachteten Veröffentlichungen und mehreren US- und EU-Patenten für Geräte, die das Wachstum von Kollateralgefäßen durch kontrollierte Scherkräfte-Therapie stimulieren. Seine Forschung verbindet mechanische und elektrische Stimulation mit vaskulärer Anpassung, Mikrozirkulation und Gewebeperfusion.
Die Beiträge von Prof. Buschmann bieten den Lesern von PureLift LAB eine gefäßbiologische Perspektive, die unsere bestehenden Autoren aus den Bereichen Klinik, Physiotherapie und chirurgische Anatomie ergänzt – und erklären, wie EMS-Stimulation nicht nur die Gesichtsmuskeln, sondern auch die Mikrozirkulation, die sie versorgt, aktiviert und warum eine intelligente Anwendung auf der Ebene des Blutflusses ebenso wichtig ist wie die Muskelkontraktion.
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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.