What a 510(k) Filing Tells You That the Product Page Does Not
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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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.