Seoul
Chief MD, Gangnam
Duk-ha Kim
The trust our patients have placed in this clinic was built on conviction and principle. We intend to hold to both, unchanged, through the next hundred years.
Radiofrequency device regulatory guide
Volnewmer
Volnewmer is a 6.78 MHz monopolar-and-bipolar radiofrequency device from Classys. Two U.S. 510(k) filings cover it, and their cleared wording addresses electrocoagulation and hemostasis of soft tissue — not lifting or tightening.
- Energy
- 6.78 MHz RF (monopolar + bipolar) — not laser, not HIFU
- Manufacturer
- Classys
- U.S. filings
- K240248 (2024-04-29) and K253504 (2026-07-13)
- Indication wording
- Electrocoagulation and hemostasis of soft tissue
What energy does Volnewmer use, and what is it not?
Volnewmer is a Classys radiofrequency device that runs at 6.78 MHz and combines monopolar and bipolar RF delivery. It is not a laser and not a HIFU (focused-ultrasound) device — the energy source is electrical current.
Sources: FDA 510(k) K240248 (2024-04-29) — Volnewmer, indications for useFDA 510(k) K253504 (2026-07-13) — Volnewmer, indications for use
How many U.S. clearances does Volnewmer have, and when?
Volnewmer has been through two separate U.S. FDA 510(k) reviews: K240248, decided 2024-04-29, and K253504, decided 2026-07-13. Both filings are for the same device name.
Sources: FDA 510(k) K240248 (2024-04-29) — Volnewmer, indications for useFDA 510(k) K253504 (2026-07-13) — Volnewmer, indications for use
What does an FDA 510(k) actually confirm?
A 510(k) is not FDA “approval.” It is a clearance decision stating that a device is substantially equivalent to an already-marketed device with the same intended use — a different regulatory pathway that does not by itself grade how well a device performs.
Why does the same device have two separate 510(k) filings?
A new 510(k) is typically filed when a device or its labeling changes and needs a fresh equivalence review, not automatically when a broader marketing claim is wanted. K253504 being decided more than two years after K240248 reflects that kind of update-and-review cycle for the same device; it is not by itself evidence that the cleared use grew.
Sources: FDA 510(k) K240248 (2024-04-29) — Volnewmer, indications for useFDA 510(k) K253504 (2026-07-13) — Volnewmer, indications for use
What is Volnewmer’s FDA product code, and what does it cover?
Both filings list product code GEI under 21 CFR 878.4400, the regulation for electrosurgical cutting and coagulation devices and accessories. That classification identifies the device category on record, not a cosmetic skin-tightening claim.
Sources: FDA 510(k) K240248 (2024-04-29) — Volnewmer, indications for useFDA 510(k) K253504 (2026-07-13) — Volnewmer, indications for use
What does the cleared indication for use actually say?
The indications-for-use wording on file reads: “Volnewmer™ is intended for use in dermatologic procedures for electrocoagulation and hemostasis of soft tissue.” That is the complete cleared statement, not a summary of it.
Sources: FDA 510(k) K240248 (2024-04-29) — Volnewmer, indications for useFDA 510(k) K253504 (2026-07-13) — Volnewmer, indications for use
Does that wording mention lifting or tightening?
No. The cleared wording covers electrocoagulation and hemostasis of soft tissue and does not contain the words lifting, tightening, or contouring. Describing Volnewmer as an FDA-cleared lifting or tightening device adds language the indications-for-use text does not say.
Sources: FDA 510(k) K240248 (2024-04-29) — Volnewmer, indications for useFDA 510(k) K253504 (2026-07-13) — Volnewmer, indications for use
Can I look up these filings myself?
Yes. K240248 and K253504 are both public FDA records; each lists the applicant, product code, regulation number, decision date, and the same indications-for-use wording quoted above. Comparing that wording to what a clinic advertises is a direct way to check a claim.
Sources: FDA 510(k) K240248 (2024-04-29) — Volnewmer, indications for useFDA 510(k) K253504 (2026-07-13) — Volnewmer, indications for use
What did the first published case series look like?
One published case series followed 30 people treated with this monopolar-and-bipolar radiofrequency device, with no control group and a follow-up window of one month.
What did the second case series look like?
A second case series enrolled 50 people, of whom 45 completed the study; it also had no control group and a one-month follow-up.
Sources: Case series of the same device (50 enrolled, 45 completed, no control group, 1-month follow-up)
Were the two studies independent of each other?
No. Both case series were published by the same author, working from a single private clinic. Two papers from one practice are not the same as replication by separate, unaffiliated research groups.
Sources: Case series of a monopolar and bipolar radiofrequency device (n=30, no control group, 1-month follow-up)Case series of the same device (50 enrolled, 45 completed, no control group, 1-month follow-up)
What does having no control group mean for these results?
Neither study compared treated patients against an untreated or sham-treated group. Without a control arm, observed changes cannot be separated from what might have happened anyway or from assessment bias, so the papers read as a case series rather than comparative evidence.
Sources: Case series of a monopolar and bipolar radiofrequency device (n=30, no control group, 1-month follow-up)Case series of the same device (50 enrolled, 45 completed, no control group, 1-month follow-up)
Can a one-month follow-up say how long results last?
No. Both case series measured outcomes at one month after treatment. That window can describe an early response; it is not long enough to describe how long an effect lasts, and neither paper followed patients further.
Sources: Case series of a monopolar and bipolar radiofrequency device (n=30, no control group, 1-month follow-up)Case series of the same device (50 enrolled, 45 completed, no control group, 1-month follow-up)
How long does the effect last?
Both published case series measured this device at one month, with no control group, and both came from the same author working at a single clinic — a one-month, uncontrolled reading describes an early response, not how long an effect holds. The cleared indications for use in both 510(k) filings also address electrocoagulation and hemostasis of soft tissue, not a lifting or tightening claim with a stated duration. Durability in practice comes down to the settings and number of sessions a clinic uses and how your own tissue responds, none of which the case series measured past one month. Ask the clinic what result they expect to see at one month, what they recommend as a session course, and how they would judge whether to repeat treatment.
Sources: Case series of a monopolar and bipolar radiofrequency device (n=30, no control group, 1-month follow-up)Case series of the same device (50 enrolled, 45 completed, no control group, 1-month follow-up)FDA 510(k) K240248 (2024-04-29) — Volnewmer, indications for useFDA 510(k) K253504 (2026-07-13) — Volnewmer, indications for use
What should you confirm with a clinic before booking?
Ask which specific device and settings will be used, ask to see the indications-for-use wording for the unit in the room, and ask what the treatment goal is in the clinic’s own words. Disclose your medical history, implanted electronic devices or metal near the treatment area, pregnancy or breastfeeding, active skin infection or disease, and any recent injectable, laser, or energy-based treatment.
When should you contact the clinic after treatment?
This is general post-procedure safety guidance, not a finding from the studies cited on this page. Contact the clinic promptly for blistering, a suspected burn, increasing pain, drainage, spreading redness or warmth, or fever. Seek emergency care for breathing difficulty, fainting, or sudden swelling of the lips, mouth, tongue or throat.
What does each Volnewmer 510(k) filing confirm?
K240248 and K253504 are two separate clearance decisions for the same device name. Reading them side by side shows what changed on paper — and what stayed the same.
| Filing | Decision date | Product code / regulation | Indication wording on file |
|---|---|---|---|
| K240248 | 2024-04-29 | GEI · 21 CFR 878.4400 | Electrocoagulation and hemostasis of soft tissue in dermatologic procedures |
| K253504 | 2026-07-13 | GEI · 21 CFR 878.4400 | Same wording — a later filing for the same device, not a broader indication |
A second 510(k) for the same device name is a separate regulatory review, not evidence that the cleared use grew to include lifting or tightening.
Sources: FDA 510(k) K240248 (2024-04-29) — Volnewmer, indications for useFDA 510(k) K253504 (2026-07-13) — Volnewmer, indications for use
Medical care at Abijou
Care is provided by the medical team at the branch you select. These clinicians lead the three branches linked from this guide; confirm the doctor assigned to your visit with that branch.
Chief MD, Myeongdong
Cheol-su Yoon
I want to be thinking about how the patient feels right up to the last moment of the procedure.
Chief MD, Hongdae
Jae-wook Kim
I will give my best with the attentiveness to catch even the smallest change.
Listed branch medical team — not a medical-review byline for this article.
Frequently asked questions
What is Volnewmer?
Volnewmer is a radiofrequency (RF) device made by Classys that delivers 6.78 MHz energy using both monopolar and bipolar modes. It is not a laser and not a HIFU (focused-ultrasound) device.
How many FDA clearances does Volnewmer have?
Two. K240248 was decided on 2024-04-29 and K253504 was decided on 2026-07-13, both for the same device name.
Is a 510(k) the same as FDA approval?
No. A 510(k) is a clearance decision showing substantial equivalence to an already-marketed device with the same intended use; it is a different regulatory pathway from “approval,” and it does not itself grade how well a device performs.
Why does Volnewmer have two 510(k) numbers instead of one?
A second 510(k) is typically filed when a device or its labeling changes and needs a new equivalence review, not automatically because a manufacturer wants a broader marketing claim. K253504 coming more than two years after K240248 reflects that kind of update cycle for the same device.
What does Volnewmer’s cleared indication for use actually say?
The wording on file states that Volnewmer is intended for use in dermatologic procedures for electrocoagulation and hemostasis of soft tissue. That sentence is the complete cleared statement.
Does the FDA clearance mention skin lifting or tightening?
No. The indications-for-use text covers electrocoagulation and hemostasis of soft tissue and does not use the words lifting, tightening, or contouring.
Is Volnewmer FDA-approved for lifting and tightening?
No such approval appears in the filings reviewed here. Both K240248 and K253504 list the same wording — electrocoagulation and hemostasis of soft tissue — and neither mentions lifting or tightening as a cleared use.
What is product code GEI, and what does it tell me?
GEI is the FDA product code both Volnewmer filings use, under 21 CFR 878.4400, the regulation covering electrosurgical cutting and coagulation devices and accessories. It identifies the device category on record, not a specific cosmetic claim.
What clinical evidence has been published on this device?
Two case series: one followed 30 people and the other enrolled 50 people, of whom 45 completed the study. Neither study used a control group, and both measured outcomes at one month after treatment.
Were the two published studies conducted independently of each other?
No. Both case series were published by the same author from a single private clinic, so they read as two reports from one practice rather than independent replication.
Why does it matter that neither study had a control group?
Without an untreated or sham-treated comparison group, changes seen in a case series cannot be separated from what might have happened without treatment, or from how outcomes were assessed. That limits how much the two published papers can say about the device’s effect on their own.
Can these studies tell me how long results last?
No. Both case series followed patients for one month after treatment, long enough to describe an early response but not long enough to describe duration, and neither study extended follow-up beyond that point.
Should I expect the same indication and evidence to apply everywhere I might be treated?
Ask rather than assume. Clearance wording, filing numbers, and the specific unit and settings in use can differ by clinic and country, so confirm the device model and its indications-for-use wording with the clinic that is treating you.
What should I disclose before a Volnewmer session?
Tell the clinic about any implanted electronic devices or metal near the treatment area, pregnancy or breastfeeding, active skin infection or disease, and any recent injectable, laser, or energy-based treatment, so the clinician can judge whether the timing and area are appropriate.
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