FDA Cleared Microcurrent Devices, How to Check Any Claim
Medically reviewed by
4 independent reviewers
Andrew Conrad Barile, Fisioterapeuta, Doctor en Terapia Física
Doctorado en Terapia Física (DPT), Fisioterapeuta Licenciado (PT)
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El Dr. Andrew Conrad Barile es Doctor en Terapia Física y CEO y Fundador de Xtreem Pulse LLC. Obtuvo su Doctorado en Terapia Física en Daemen College y aporta más de dos décadas de experiencia clínica y empresarial en terapia física pediátrica, terapia craneosacral e innovación en dispositivos médicos. Su profundo conocimiento de la anatomía humana, la fisiología muscular y la tecnología terapéutica ofrece un enfoque invaluable respaldado por la ciencia para la rejuvenecimiento facial y soluciones antienvejecimiento.
Bertica M. Rubio, M.D.
Director Médico, Clínica de Medicina Regenerativa y Antienvejecimiento | Médico Certificado por la Junta | Escuela de Medicina de Dartmouth
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La Dra. Bertica M. Rubio es una médica certificada y Directora Médica de la Clínica de Medicina Regenerativa y Antienvejecimiento en Redlands, California. Obtuvo su licenciatura en Ciencias en la Universidad Loyola Marymount y su título de Doctora en Medicina en la Escuela de Medicina de Dartmouth (Geisel School of Medicine). Completó su residencia en pediatría en el Centro Médico UC Irvine.
Con décadas de experiencia clínica, la Dra. Rubio se especializa en medicina para el manejo de la edad, medicina regenerativa, cicatrización de heridas y terapias con factores de crecimiento. Su práctica integra la ciencia médica basada en evidencia con tratamientos estéticos y regenerativos avanzados, ayudando a los pacientes a alcanzar una salud óptima y vitalidad juvenil.
La Dra. Rubio siente pasión por educar a los pacientes sobre la ciencia detrás del cuidado de la piel, el rejuvenecimiento facial y las tecnologías no invasivas como EMS (Estimulación Eléctrica Muscular) para el tonificado facial. Sus artículos para PureLift LAB combinan un conocimiento médico riguroso con orientación práctica para lograr resultados reales y duraderos.
Daniel Grinberg, MD, FACS
Otorrinolaringólogo y cirujano de cabeza y cuello certificado | Miembro, Colegio Americano de Cirujanos | Profesor clínico asistente, Escuela de Medicina Mount Sinai
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Daniel Grinberg, MD, FACS, es un otorrinolaringólogo certificado por la junta y cirujano de cabeza y cuello en ENT and Allergy Associates en West Nyack, NY. Obtuvo su título de médico en la Facultad de Médicos y Cirujanos de la Universidad de Columbia, completó su residencia en Otorrinolaringología en el Centro Médico de la Universidad de Nueva York y es profesor clínico asistente en la Escuela de Medicina Mount Sinai. Es miembro de la American College of Surgeons y de la American Academy of Otolaryngology.
La perspectiva quirúrgica de cabeza y cuello del Dr. Grinberg ofrece a los lectores de PureLift LAB una visión clínica más amplia, conectando la práctica de EMS en casa con la anatomía médica subyacente con el mismo rigor científico que aplicamos a cada especificación del dispositivo.
Prof. Dr. med. Ivo Buschmann
Cátedra de Angiología, Hochschule Médica de Brandeburgo | Director de Clínica, Clínica Universitaria de Angiología, Hospital Universitario de Brandeburgo | Ex Consultor Senior, Charité Universitätsmedizin Berlín
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El Prof. Dr. med. Ivo Buschmann es Catedrático de Angiología en la Medizinische Hochschule Brandenburg Theodor Fontane (MHB) y Director Clínico de la Clínica Universitaria de Angiología en el Hospital Universitario de Brandeburgo. Completó su formación médica en la Universidad de Hamburgo, fue becario de la Sociedad Max-Planck en el Instituto Max-Planck de Investigación Cardiaca y Pulmonar, y ocupó cargos de consultor senior en la Charité Universitätsmedizin Berlin Campus Virchow antes de ser nombrado Catedrático en la MHB en 2016.
El Prof. Buschmann es una de las principales autoridades europeas en arteriogénesis — el crecimiento y remodelación de los vasos sanguíneos impulsados por el flujo — con más de 150 publicaciones revisadas por pares y varias patentes en EE. UU. y la UE sobre dispositivos que estimulan el crecimiento de vasos colaterales mediante terapia controlada de tasa de cizalladura. Su investigación conecta la estimulación mecánica y eléctrica con la adaptación vascular, la microcirculación y la perfusión tisular.
Las contribuciones del Prof. Buschmann aportan a los lectores de PureLift LAB una perspectiva de biología vascular que complementa nuestra autoría clínica, de fisioterapia y de anatomía quirúrgica existente — explicando cómo la estimulación EMS activa no solo los músculos faciales sino también la microcirculación que los abastece, y por qué la administración inteligente es tan importante a nivel del flujo sanguíneo como en la contracción muscular.
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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.