Is Shurink like Ultherapy?
Same kind of HIFU. Not the identical machine.
Does it have an FDA lift label?
Not yet. It hasn’t been reviewed for that in the US.
Will it ever?
A head-to-head US trial with Ultherapy is running now.
Short answer:
- No Korean HIFU, including Shurink (슈링크) and Ultraformer MPT (울트라포머), has the US FDA “lift” indication that Ultherapy has (“lift the eyebrow,” “lift lax submental and neck tissue”), based on my FDA database search on 14 October 2026. That means it hasn’t been reviewed for that use in the US, not that it doesn’t work.
- Korea has already cleared it for brow lifting. Korea’s regulator lists Ultraformer MPT PLUS for “eyebrow lifting by coagulating tissue.” Both machines focus ultrasound at similar depths, so a similar result is a fair expectation, though not an identical one. (Clinical judgement, not a proven fact.)
- A US trial is testing exactly that: Ultraformer MPT PLUS against Ultherapy, 1:1, about 273 people, now recruiting [4]. At the consultation, ask about depth, shot count and who treats you.
What does Ultherapy’s FDA label say?
Ultherapy’s latest FDA clearance, K260618 (2026), lists [1]:
- “lift the eyebrow”
- “lift lax submental (beneath the chin) and neck tissue”
- “improve lines and wrinkles of the décolleté”
- improve skin laxity on the stomach, arms and knees
These are “temporary changes in the physical appearance of the skin,” so the effect fades.
How do Korean HIFU machines show up at the FDA?
- Ultraformer (Shurink in Korea) by Classys: I could not find it by name in the FDA 510(k) database.
- SCIZER, a Classys HIFU, is FDA cleared (K230100), but for “non-invasive waist circumference reduction,” not the face [2].
- In the whole FDA focused-ultrasound group, the only other Korean entry was Jeisys LIPOcel (K181896).
So a Korean company has passed US HIFU review before. A face and neck lift label simply hasn’t been applied for yet.
What has Korea’s regulator cleared?
Korea’s MFDS record (viewed 14 Oct 2026) for Ultraformer MPT PLUS [3]:
- Maker: Classys. Class 3 focused ultrasound stimulator system.
- Clearance no. 26-208, dated 18 March 2026.
- Intended use: “a device used for eyebrow lifting by coagulating tissue.”
- Reviewed on technical documents, not clinical data.
That is the same kind of wording as Ultherapy’s “lift the eyebrow.” Korea treats it as the same type of heat-based lifting device.
Older models, per the maker’s press release [5]: Shurink was cleared in October 2021 to improve wrinkles around the eyes, mouth and neck. Shurink Universe added the same wrinkle uses to its brow-lifting use in late 2024.
Will the result be similar?
My view, a clinical judgement and not a proven fact: both machines make small heat spots at about 1.5, 3.0 and 4.5 mm deep (Ultraformer also has 2.0 mm), so the tissue should respond in a similar range. Depth choice, shot count and the doctor’s hands matter more. For the machine-by-machine details, see Ultraformer vs Ultherapy.
What is the US trial?
ClinicalTrials.gov, checked 14 October 2026 [4]:
- NCT07229430, sponsored by Classys.
- Design: several centers, random 1:1 split, compared directly with Ultherapy, patients and graders blinded, non-inferiority (is it “not meaningfully worse”).
- Size: about 273 people at 5 US sites.
- Main result: chin lift at 90 days. Recruiting.
Classys said in March 2025 that the FDA approved its trial plan (IDE), per a news report [6]. A head-to-head design shows how close the machines are. If it passes, Classys could apply for the same lift label. No result yet.
What should I ask at the consultation?
- Which depths, and how many shots? That is the size of the treatment.
- Which area is the target? Even Ultherapy’s label names specific areas.
- Who does it? HIFU needs careful hands near thin spots with nerves and fat.
If a result disappoints, here is why that can happen.
What I tell my patients
“It works the same way as Ultherapy. Korea has cleared it for brow lifting. It has no US lift label yet, and it is in a head-to-head US trial to get one. Your result depends more on depth, shots and the doctor than on the name.”
Have a question about your own case? Ask me on LINE or by email — details on the Contact page.
FAQ
Is Shurink FDA approved?
Shurink (Ultraformer) has no FDA clearance under its name that I could find in the FDA 510(k) database on 14 October 2026. In Korea, the MFDS cleared Ultraformer MPT PLUS for eyebrow lifting on 18 March 2026. A US trial against Ultherapy (NCT07229430) is recruiting.
Is Ultraformer FDA approved?
Ultraformer MPT is not FDA cleared for lifting yet. Classys is running a 1:1 randomized US trial against Ultherapy (NCT07229430, about 273 people) for chin and neck lift. Its only FDA-cleared HIFU I found, SCIZER (K230100, 2023), is for waist circumference.
Is Korean HIFU as good as Ultherapy?
Korean HIFU works the same way and at similar depths, so a similar result is a fair expectation, but not an identical one (clinical judgement). The head-to-head US trial (NCT07229430) is testing exactly this and has no result yet.
Which HIFU has an FDA lift indication?
Ultherapy (Ulthera System) has it: “lift the eyebrow” and “lift lax submental and neck tissue,” most recently in K260618 (21 May 2026), first cleared in 2009. I found no Korean HIFU with a lift indication on 14 October 2026.
References
- US FDA. 510(k) K260618, Ulthera System, 21 May 2026. accessdata.fda.gov
- US FDA. 510(k) K230100, SCIZER (Classys), 3 Nov 2023. accessdata.fda.gov
- Korea MFDS, medical device clearance 26-208 (Ultraformer MPT PLUS, Classys), viewed 14 Oct 2026. emedi.mfds.go.kr
- ClinicalTrials.gov. NCT07229430, Ultraformer MPT PLUS vs Ulthera System for submental and neck lift.
- Classys press release, 7 Jan 2025 (in Korean). classys.co.kr
- Hit News, 27 Mar 2025 (in Korean). hitnews.co.kr
Disclaimer: This article explains treatments in general terms and is not a diagnosis or a treatment plan. What happens varies from person to person, and no article can tell you what to expect. Please discuss your own case with a licensed medical professional where you live. I do not endorse specific clinics or device brands.
14 years in practice · replies to messages herselfA doctor in Korea, in practice since 2012 — your K-Beauty Doc. Physician in non-surgical aesthetic medicine, practising in Ansan, South Korea. Every article here is written from clinical practice and the published literature. Not medical advice.
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