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.
Seoul
New HIFU device — evidence gap and approval-scope guide
10TRIPLE is a 2025-launch focused-ultrasound (HIFU) device from the Korean manufacturer Tentech that fires three ultrasound lines at once; its published intended-use notice covers eyebrow lifting, and independent research on this specific model has not yet been published.
10TRIPLE is a focused-ultrasound device from the Korean manufacturer Tentech, launched in 2025. Because it is genuinely new hardware, this page is built around what is not yet documented rather than a feature list — the gaps matter as much as the specifications.

Sources: 10TRIPLE — manufacturer product site, statutory notice stating the intended use
The manufacturer’s own product site describes 10TRIPLE as focused ultrasound (HIFU) alone, delivered along three lines at the same time. No radiofrequency component appears in that material, so calling 10TRIPLE a “combination energy” or “HIFU+RF” device goes beyond what the source states.
Sources: 10TRIPLE — manufacturer product site, statutory notice stating the intended use
It describes how the transducer fires: three ultrasound lines are delivered in one pass instead of one line at a time. That is a description of the delivery pattern, not a claim about speed, comfort, or outcome compared with a single-line HIFU device.
Sources: 10TRIPLE — manufacturer product site, statutory notice stating the intended use
Korean manufacturers of focused-ultrasound systems must publish a statutory notice describing the device’s approved intended use. For 10TRIPLE, that notice describes a focused-ultrasound stimulation system used to coagulate tissue in order to lift the eyebrows — it does not describe a general face-lifting indication.
Sources: 10TRIPLE — manufacturer product site, statutory notice stating the intended use
The wording above does not extend to the cheeks, jawline, or neck. If a clinic positions 10TRIPLE for full-face or neck lifting, that goes beyond the intended-use notice published on the manufacturer’s own site, so it is reasonable to ask which area the approved wording actually covers.
Sources: 10TRIPLE — manufacturer product site, statutory notice stating the intended use
A Korean medical-device manufacturing license for 10TRIPLE was announced on 2025-08-18. The announcement confirms a license was granted; it does not publish the license number itself.
Sources: 10TRIPLE — manufacturer product site, statutory notice stating the intended use
Without a published number, there is nothing yet to check against Korea’s public device registry to independently confirm the exact scope of what was approved. That gap does not make the approval invalid — it means the number needed to verify it directly is not public, so ask the clinic to provide it before treatment.
The number posted alongside 10TRIPLE marketing material on the manufacturer’s site is a medical-device advertising-review number, not a manufacturing-license number. An advertising-review number confirms that a specific advertisement was screened under Korea’s ad rules; it does not stand in for, or verify, the device’s own approval number.
Sources: 10TRIPLE — manufacturer product site, statutory notice stating the intended use
No peer-reviewed study of 10TRIPLE has been identified. That is unsurprising for a device that only reached market in 2025 — independent clinical literature on a device typically follows its commercial launch by months or years, not the reverse.
Tentech’s earlier HIFU device has a retrospective study behind it, but patients in that study were assigned by preference rather than randomized, and the study evaluated a different, older model. Neither the study design nor the device generation supports carrying its numbers over to 10TRIPLE.
Public reporting describes 10TRIPLE as having received certification in some markets outside Korea, but the original FDA or CE filings have not been located. Until those primary documents can be checked directly, treat “overcertified overseas” as a headline rather than a confirmed regulatory status.
“No evidence yet” describes the state of the published literature, not the device’s performance. It means no controlled study of 10TRIPLE has been published to confirm what it does or does not achieve — that is a different statement from “proven not to work,” and treating it as equivalent skips the actual question, which is what you are willing to accept without that confirmation.
Shot counts, line counts, cartridge choice, and treatment depth are set by each manufacturer’s own hardware and are not standardized across brands. A 3-line pass on 10TRIPLE is not the same unit as a single-line pass on a different HIFU device, so comparing raw numbers between devices does not tell you which one delivers more energy or a better outcome.
Clinics sometimes add a newly launched device because it is new hardware from an established Korean manufacturer — not because independent evidence has already accumulated for that specific model. That is a legitimate reason to offer it, and it is also a legitimate reason to ask more questions before booking; the two are not in conflict.
No study of 10TRIPLE itself has been published, so this page cannot cite a duration figure for it — the same peer-review gap already noted above. Tentech’s earlier HIFU device does have a retrospective study behind it, but that trial assigned patients by preference rather than at random and evaluated a different, older model, so its numbers do not carry over to how long any change from 10TRIPLE might last. What tends to decide how long this kind of treatment holds up is the energy actually delivered to the target layer, the area treated, and each patient’s own tissue response — none of which this page can quantify for a device with no published study behind it. Ask the clinic what they are relying on when they answer this question, and whether they can point to a source for any duration figure they quote.
Ask the clinic to show the manufacturer’s intended-use wording and confirm which area it covers, to state plainly that the device is HIFU only, to explain the difference between the advertising-review number and the manufacturing-license number, and to describe what — if anything — they are relying on for expected outcomes given the current lack of published studies on this specific model.
This table separates what the manufacturer’s own material documents from what a quote has to specify. It is not a ranking against other HIFU devices, and it is not a substitute for asking the clinic directly.
| Item | Confirmed | Not confirmed |
|---|---|---|
| Energy technology | Focused ultrasound (HIFU) only, 3-line simultaneous irradiation | Any combination with radiofrequency (RF) energy |
| Approved intended use | Eyebrow lifting, via focused-ultrasound tissue coagulation | Full-face, neck, or jawline lifting |
| Korean manufacturing license | A license was announced on 2025-08-18 | The specific license number |
| Number shown with marketing | An advertising-review number is displayed | That this number is the same as, or verifies, a manufacturing-license number |
| Clinical evidence on this model | None published to date (device launched in 2025) | Whether an older Tentech model’s retrospective study results transfer to 10TRIPLE |
| Overseas certification | Reports that some overseas markets granted certification | Original FDA or CE filing documentation |
Confirming an item here means it appears in the manufacturer’s own material — it is not an endorsement, and it does not compare 10TRIPLE against other HIFU systems.
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, Gangnam
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.
Chief MD, Myeongdong
I want to be thinking about how the patient feels right up to the last moment of the procedure.
Chief MD, Hongdae
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.
10TRIPLE is a focused-ultrasound (HIFU) device made by the Korean manufacturer Tentech, launched in 2025, that fires three ultrasound lines simultaneously in a single pass. It is a genuinely new device, so independent evidence about it is still limited.
No — the manufacturer’s own material describes it as focused ultrasound alone. No radiofrequency component is documented, so a “combination energy” description would go beyond what the source states.
The statutory notice describes a focused-ultrasound stimulation system used to coagulate tissue in order to lift the eyebrows. It does not describe a general face or neck-lifting indication.
That use is outside the documented intended-use wording, which covers eyebrow lifting only. If a clinic proposes it for the whole face or neck, ask them to show which official wording supports that use.
A Korean medical-device manufacturing license was announced on 2025-08-18. The announcement confirms a license exists; it does not itself publish the license number.
It has not been publicly disclosed. Ask the treating clinic to provide it so the approval scope can be checked directly against Korea’s device registry.
No — it is a medical-device advertising-review number, which confirms an advertisement was screened under Korea’s ad rules. It does not verify, or stand in for, the manufacturing-license number.
None has been identified. The device only launched in 2025, and independent clinical literature typically appears after commercial launch, not before it.
Not directly. That study used preference-based patient assignment rather than randomization and evaluated a different, older model, so its results do not transfer to 10TRIPLE.
Only secondhand reports of certification in some overseas markets exist so far; the original FDA or CE filings have not been located, so this should not be treated as a confirmed regulatory status.
No — it means no controlled study has confirmed what it does or does not achieve yet. “Not yet studied” and “proven ineffective” are different statements, and this page only supports the first.
No — shot count, line count, cartridge and depth are set by each manufacturer’s own hardware and are not standardized units across brands, so raw numbers are not directly comparable.
Offering new hardware from an established Korean manufacturer is a legitimate business reason on its own; it does not require independent evidence to already exist for that specific model. That is exactly why it is worth asking more questions before booking.
Ask to see the manufacturer’s intended-use wording and which area it covers, confirm the device is HIFU only, ask the clinic to distinguish the advertising-review number from the manufacturing-license number, and ask what they are basing expected outcomes on given the current lack of published studies.
We started in Gangnam in 2006 and the network now runs 17 branches across Korea. The line we work to is skin transformation woven into everyday life — care you can keep up with, rather than one dramatic change.
Free Consultation
There is no inquiry form on this page. Once you have picked a branch above, open that branch’s site or the official reservation center and choose a time yourself.