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