FDA Cleared Microcurrent Devices, How to Check Any Claim
Medically reviewed by
4 independent reviewers
Andrew Conrad Barile, PT, DPT
Doctor of Physical Therapy (DPT) | Licensed Physical Therapist (PT) | CEO and Founder, Xtreem Pulse LLC
Read bio
Dr. Andrew Conrad Barile is a Doctor of Physical Therapy and the CEO and Founder of Xtreem Pulse LLC, the engineering company behind PureLift. He earned his Doctorate in Physical Therapy from Daemen College and is a licensed physical therapist.
He brings over two decades of clinical and entrepreneurial experience across physical therapy, craniosacral therapy and medical device innovation, built on a working knowledge of human anatomy and muscle physiology.
For PureLift LAB he reviews how current is delivered across all ten levels, from sub-sensory nanocurrent and skin-level microcurrent to motor-level EMS, and how the Infuse pass fits into the same ten-minute routine.
Bertica M. Rubio, M.D.
Board-Certified Physician, Dartmouth Medical School | Medical Director, Antiaging Regenerative Medicine Clinic
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Dr. Bertica M. Rubio is a board-certified physician and Medical Director of the Antiaging Regenerative Medicine Clinic in Redlands, California. She earned her Doctor of Medicine from Dartmouth Medical School and completed her pediatrics residency at UC Irvine Medical Center.
With decades of clinical experience, she specialises in age management medicine, regenerative medicine, wound healing and growth factor therapies, and her practice integrates evidence-based medical science with advanced aesthetic treatment.
For PureLift LAB she reviews articles for medical accuracy across the whole dial, from the gentle nanocurrent and microcurrent settings through to muscle-level EMS and the Infuse pass.
Daniel Grinberg, MD, FACS
Board-Certified Otolaryngologist | Head and Neck Surgeon | Fellow, American College of Surgeons | Mount Sinai
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Daniel Grinberg, MD, FACS is a board-certified otolaryngologist and head and neck surgeon at ENT and Allergy Associates in West Nyack, New York. He earned his medical degree from Columbia University College of Physicians and Surgeons.
He completed his otolaryngology residency at New York University Medical Center, serves as Assistant Clinical Professor at Mount Sinai School of Medicine, and is a Fellow of both the American College of Surgeons and the American Academy of Otolaryngology.
For PureLift LAB he brings a wider clinical lens, connecting at-home facial stimulation from microcurrent to EMS to the anatomy underneath, with the same rigour we apply to every device specification.
Prof. Dr. med. Ivo Buschmann
Chair of Angiology, Medizinische Hochschule Brandenburg | Clinic Director, University Clinic for Angiology
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Prof. Dr. med. Ivo Buschmann is Chair of Angiology at the Medizinische Hochschule Brandenburg Theodor Fontane and Clinic Director of the University Clinic for Angiology at the Brandenburg University Hospital.
He trained at the University of Hamburg, was a Max Planck Society Fellow at the Max Planck Institute for Heart and Lung Research, and held senior consultant posts at the Charite Universitatsmedizin Berlin before his appointment as Chair in 2016.
One of Europe's leading authorities on arteriogenesis, with over 150 peer-reviewed publications and US and EU patents, he reviews for PureLift LAB how the evidence on electrical stimulation is read and where its limits lie.
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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.