What a 510(k) Filing Tells You That the Product Page Does Not
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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Almost every real number in this category is published, to the FDA, in a document the buyer is never pointed at.
This article explains what is actually happening, such as:
- how to find a filing in about two minutes
- which section holds the output figures and which is marketing
- the difference between a 510(k) Summary and a Statement
- what the indications for use section actually permits
- eight devices whose real figures we pulled this way
and many more!
Everything below can be checked by anyone with a browser, which is the whole point of writing it down.
Key Points:
A 510(k) filing is the document a manufacturer submits to show a device is substantially equivalent to one already on the market.
Filings come as Summaries, which publish a specification, or Statements, which do not, and that choice decides whether you can see any numbers.
Ya-Man files 3.22 mA at 500 ohms for the Medi Lift PLUS and publishes no output figure on its own site.
Shark files 128 mW/cm2 and doses up to 431 J/cm2 for the CryoGlow, and publishes wattage and cord length on the product page instead.
A clearance is a finding of equivalence to an older device, not a finding that a device works.
Finding the filing
Go to the FDA 510(k) database at accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm.
Search the applicant name first, then the device name, because clearances usually sit with the contract manufacturer rather than the brand on the box.
A Shenzhen or Jodhpur manufacturer holding the record is completely normal and not a warning sign.
When you find the record, look for the link to the summary PDF, because the database entry alone gives you dates and codes rather than engineering.
Summary or Statement, and why it decides everything
A manufacturer may file a 510(k) Summary, which publishes a technical description, or a 510(k) Statement, which certifies that safety and effectiveness information will be provided on request and publishes nothing.
Both are legitimate and the choice is the manufacturer's.
Bio-Therapeutic's clearances are Statements, which is why no output figure for the bt-sculpt exists anywhere in public, at any price, from any source.
So a missing number is sometimes a filing choice rather than concealment, and the practical result for you is identical.
The sections worth reading
Device description tells you what the thing physically is, including electrode count, electrode area and how it is meant to be worn or held.
The comparison table sets the device against its predicate, and this is where output current, voltage, frequency, pulse width, waveform and charge density live, usually at stated loads.
Indications for use is the single most useful paragraph, because it states what the device is cleared to be used for, in full, and nothing outside it is covered.
Ya-Man's Medi Lift PLUS reads intended for facial stimulation and indicated for over-the-counter cosmetic use, which is the whole of it.
Performance data lists the standards testing done, which is reassurance about safety rather than evidence of an aesthetic result.
What we found in eight of them
Ya-Man publishes 3.22 mA at 500 ohms, pulse widths from 52 to 192 microseconds and a full frequency list, and nothing on its consumer pages.
NuFACE files 335 microamps with a range from 70 to 335 for the MINI+, with no load stated even in the filing.
Shark files 630, 415 and 830 nm at a total of 128 mW/cm2, with delivered doses reaching 431 J/cm2, and publishes none of it where the mask is sold.
7E Wellness files 350 microamps at 500 ohms at 0.625 Hz for the MyoLift QT, the only device in its range with published figures.
Solawave files roughly 0.31 mA at 500 ohms and also publishes irradiance and current on its own site, which almost nobody else does.
CurrentBody files per-wavelength irradiance for its newer mask and a delivered dose of 18 J/cm2 for the previous one, and sells on LED counts.
HigherDOSE files 30 J/cm2 and publishes 50 mW/cm2 on the page, which makes it one of two brands where you can check without leaving the shop.
Qure files 15 to 70 mW/cm2 depending on mode and publishes wavelengths and LED counts only.
What a clearance does not mean
Substantial equivalence means the device is comparable to a predicate already on the market, and predicates chain backwards, sometimes to devices cleared decades ago.
It is not a finding that the device produces any particular aesthetic result, and it is not an endorsement.
It also does not cover claims outside the indications, so a clearance for facial stimulation does not support a claim about collagen synthesis or jawline lifting.
That gap between what is cleared and what is advertised is worth checking on any device you are about to buy, ours included.
Where PureLift sits
Face and Pro publish 7 mA at 500 ohms, Pro Edition 7.7 mA, and Pro Plus and GLOW 9 mA, with a 4 microsecond pulse width across the range.
GLOW publishes 1.13 W/m2 and 678 J/m2 over ten minutes for its light, which converts to 0.113 mW/cm2 and 0.068 J/cm2, and that conversion does not flatter us against a dedicated mask.
Clearances are K190269, K230506, K221443 and K243587, and the devices are made in Japan in an ISO 13485 facility.
We publish on the page what other brands file with the regulator, and we would rather compete that way.
This comparison 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.
Filings and figures verified on 21 September 2026 against the FDA 510(k) database and each brand's own published material.