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
HIFU + RF combination device guide
V-RO Advance is a combination system made by Hironic, built from separate HIFU and RF handpieces and exported under the name NEW DOUBLO 2.0. It is not a laser device, and the manufacturer material pairs a lifting indication only with the eyebrow area.
Clinics list this treatment under a menu name built around the number "2." Manufacturer material identifies the underlying system as V-RO ADVANCE, made by Hironic and exported under the name NEW DOUBLO 2.0.

Sources: V-RO ADVANCE — manufacturer product site, stated intended use for each device category
No. V-RO Advance combines focused-ultrasound (HIFU) handpieces with radiofrequency (RF) handpieces. Some regional menu translations use the word "laser" in the treatment name, but the manufacturer material describes the energy sources as ultrasound and RF, not laser light.
Sources: V-RO ADVANCE — manufacturer product site, stated intended use for each device category
Manufacturer material lists five handpieces: SD and FL, which deliver focused ultrasound; RM and RM(B), which deliver bipolar RF through a microneedle applicator; and PS, which delivers plasma energy.
Sources: V-RO ADVANCE — manufacturer product site, stated intended use for each device category
The FDA cleared NEW DOUBLO 2.0 under 510(k) K251334 on 2025-09-29, classified under 21 CFR 878.4400, product code GEI. The clearance states the RM and RM(B) handpieces are "intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis," and the PS handpiece is "used in the removal and destruction of skin lesions and coagulation of tissue."
Sources: FDA 510(k) K251334 (2025-09-29) — NEW DOUBLO 2.0 clearance summary, indications for use by handpiece
The manufacturer site lists three separate intended-use categories for the system. The focused-ultrasound category — described as a device that coagulates tissue — is the one paired with a lifting indication, and that lifting indication is limited to the eyebrow area.
Sources: V-RO ADVANCE — manufacturer product site, stated intended use for each device category
A second intended-use category describes a general-purpose electrosurgical instrument that uses RF current to coagulate tissue. This category carries no lifting wording.
Sources: V-RO ADVANCE — manufacturer product site, stated intended use for each device category
A third intended-use category describes an RF stimulator used for pain relief. This category also carries no lifting wording.
Sources: V-RO ADVANCE — manufacturer product site, stated intended use for each device category
A clinic-sponsored split-face study enrolled 21 participants and compared focused ultrasound alone against focused ultrasound combined with RF, applied to opposite sides of the same face. The authors were affiliated with the treating clinic rather than the device manufacturer.
The study followed participants for eight weeks and compared two active treatment arms rather than an active arm against an untreated control. Its published results describe that eight-week window and that arm-to-arm comparison.
A separate piece of literature on this device lineage was published as a letter to the editor rather than as a full original research article, so it is presented here as a note rather than as clinical evidence alongside the split-face study.
Manufacturer material pairs each named handpiece with its own use: eyebrow-area lifting for the focused-ultrasound handpieces (SD, FL), and lesion removal with tissue coagulation for the plasma handpiece (PS), alongside a separate RF-stimulator category for pain relief. Because these uses differ, the handpiece and area planned for a session should follow the concern assessed at consultation.
Sources: V-RO ADVANCE — manufacturer product site, stated intended use for each device category
The handpieces are cleared or described for different purposes rather than as substitutes for each other. The table below lines up what the U.S. clearance and the Korean-market wording from the manufacturer each say for every handpiece.
Sources: FDA 510(k) K251334 (2025-09-29) — NEW DOUBLO 2.0 clearance summary, indications for use by handpieceV-RO ADVANCE — manufacturer product site, stated intended use for each device category
The one published split-face study on this device lineage followed participants for eight weeks and compared two active treatment arms against each other, not an active arm against an untreated control, and its authors were affiliated with the treating clinic. An eight-week, arm-to-arm comparison can describe a difference between the two settings tested; it does not establish how long either result holds after that window closes. The manufacturer’s own eyebrow-lift wording likewise states a use, not a duration. What would actually decide durability — which handpieces and settings are used, how many sessions, and how your own tissue responds — is not stated as a number here. Ask the clinic what result they expect at eight weeks, whether they recommend a maintenance session, and on what basis they would schedule one.
Sources: V-RO ADVANCE — manufacturer product site, stated intended use for each device category
Confirm which handpieces are planned for your session and why, which area is being assessed, whether the goal matches the eyebrow-lift, coagulation, or pain-relief use listed for that handpiece, and what energy and settings are planned for your anatomy. Disclose current medicines, pregnancy or breastfeeding, implanted electronic devices, active skin infection or disease, and any recent energy-based or injectable treatments in the same area.
Contact the treating clinic promptly if you notice a suspected burn, swelling, pain, or a skin change that persists or worsens after your session.
Compare the exact handpiece being proposed against the wording each source states for that handpiece, rather than assuming the indication for one handpiece applies to another.
| Handpiece | Energy | U.S. 510(k) K251334 wording | Korean-market wording from the manufacturer |
|---|---|---|---|
| SD, FL | Focused ultrasound (HIFU) | — | Focused-ultrasound category: coagulates tissue, used for eyebrow-area lifting |
| RM, RM(B) | Bipolar RF (microneedle) | "Intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis" | General-purpose electrosurgical category: RF current coagulates tissue, no lifting wording |
| PS | Plasma | "Used in the removal and destruction of skin lesions and coagulation of tissue" | — |
| RF stimulator (Korean-market category) | Radiofrequency | — | RF-stimulator category: used for pain relief, no lifting wording |
This table lines up sourced wording per handpiece or category. It is not a ranking, and it does not state that any handpiece is approved for lifting outside the eyebrow area.
Sources: FDA 510(k) K251334 (2025-09-29) — NEW DOUBLO 2.0 clearance summary, indications for use by handpieceV-RO ADVANCE — manufacturer product site, stated intended use for each device category
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.
Manufacturer material identifies the system as V-RO ADVANCE, made by Hironic and exported under the name NEW DOUBLO 2.0. The menu listing adds the digit "2," which is a clinic-side name rather than part of that manufacturer model name.
No, it is not a laser. It combines focused-ultrasound (HIFU) handpieces with radiofrequency (RF) handpieces, and the manufacturer material describes the energy sources as ultrasound and RF rather than laser light.
It uses five handpieces: SD and FL for focused ultrasound, RM and RM(B) for bipolar RF delivered through a microneedle applicator, and PS for plasma.
The FDA cleared NEW DOUBLO 2.0 under 510(k) K251334 on 2025-09-29, classified under 21 CFR 878.4400, product code GEI, with stated indications for the RM, RM(B) and PS handpieces.
It states the RM and RM(B) handpieces are "intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis."
It states the PS handpiece is "used in the removal and destruction of skin lesions and coagulation of tissue."
Only in the focused-ultrasound intended-use category, and only for the eyebrow area. The other two intended-use categories describe coagulation and pain relief without lifting wording.
No. That category describes an instrument that coagulates tissue with RF current and carries no lifting wording.
No. That category describes RF energy used for pain relief and carries no lifting wording.
A clinic-sponsored study enrolled 21 participants and compared focused ultrasound alone against focused ultrasound combined with RF, on opposite sides of the same face. The authors were affiliated with the treating clinic rather than the manufacturer.
It followed participants for eight weeks and compared two active treatment arms rather than an active arm against an untreated control, so its published results are limited to that window and that comparison.
Yes, but it was published as a letter to the editor rather than as a full original research article, so it is presented here as a note rather than as clinical evidence alongside the split-face study.
Manufacturer material pairs each handpiece with its own documented use, so the handpiece and area used in a session should follow the concern assessed at consultation rather than a single fixed protocol.
Confirm which handpieces are planned, which area is being assessed, and whether the goal matches that handpiece documented use. Disclose current medicines, pregnancy or breastfeeding, implanted electronic devices, active skin infection or disease, and recent energy-based or injectable treatments in the same area.
Contact the treating clinic promptly if you notice a suspected burn, swelling, pain, or a skin change that persists or worsens after your session.
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.
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