Is Oligio like Thermage?
The FDA says it makes the same kind of heat.
So it’s FDA approved?
It’s 510(k) cleared, matched to Thermage on paper.
Will my result be similar?
You can expect similar. Not identical.
Short answer:
- Oligio (올리지오, Wontech), 10Therma (텐써마, Tentech) and XERF (세르프, Lutronic) are US FDA 510(k)-cleared as equivalent to Thermage FLX for the same kind of heat, but their FDA labels do not include wrinkles.
- The missing wrinkle line is about what the paperwork covered, not proof that they don’t work. When the technology is this close, a similar result is a fair expectation, but not an identical one. (Clinical judgement, not a proven fact.)
- So choosing one of them in Korea is reasonable. Ask about power, shot count and who treats you, not the brand name.
What does a 510(k) check?
A 510(k) is a paper review. A company shows the FDA that its new machine is “substantially equivalent” to one already sold in the US. That older machine is called the predicate.
For all three Korean devices, the predicate is Thermage FLX. The FDA looks at how the machine works, its specs and its safety tests. It is not a clinical trial of results. That is why the right word is “cleared,” not “approved.”
What did the FDA accept?
- Thermage FLX (Solta Medical), K170758, 2017. Its label includes “non-invasive treatment of wrinkles and rhytids,” including around the eyes [1]. This is the reference machine.
- The Oligio (Wontech), K221989, 2022. Predicate: Thermage FLX. Same 6.78 MHz monopolar RF, cooling the top layer while heating below. The summary says its power sits inside the predicate’s range [2]. The newer Oligio X is K240313 (2024) and K243929 (2025) [3].
- 10Therma (Tentech), K232992, 2023. Predicate: Thermage FLX. The summary says it uses “similar or identical technology” [4].
- XERF (Lutronic), K251327, 2025. Predicate: Thermage FLX. This file goes furthest. Lutronic put temperature sensors 3 mm deep in donated skin and compared heating curves with Thermage FLX side by side, reporting equivalent “heating and cooling behavior” [5].
None of the three summaries included a clinical trial. That is normal for a 510(k).
What did the FDA not look at?
The three Korean labels list “electrocoagulation and hemostasis,” a general heat-device use. They do not list wrinkles.
That means the FDA did not test a wrinkle claim for these machines. It does not mean the FDA found they fail. A wrinkle line goes on a US label only if the company applies for it, and these makers have not done that.
So will the result be similar?
My view as a doctor, a clinical judgement and not a proven fact: if the same kind of RF heat reaches the same depth for a similar time, the skin should respond in a similar range. XERF even checked the heat curve.
Oligio has a 20-person study on facial laxity [6]. 10Therma has a 26-person look-back study using Thermage-like settings, where color change was the main goal [7]. They are too small to call the machines equal, but they point the same way.
Similar is not identical. Tip size, shot count, power and the doctor’s hands change the result.
Why do Korean clinics use these machines?
They are made in Korea, so they cost less to buy and run, and that often shows up in the price. For more on the machines themselves, see Thermage vs Oligio vs 10Therma.
What should I ask at the consultation?
- Which tip, and how many shots? These numbers tell you the size of the treatment.
- How is the power set? Is it adjusted to how your skin responds?
- Who does it? Is it a doctor, and how long have they used this machine?
What I tell my patients
When someone only knows the Thermage name, I say this: “The US FDA cleared this machine as making the same kind of heat as Thermage. There’s no wrinkle line on its label because it wasn’t reviewed for that. Your result depends more on the settings and the person 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 Oligio FDA approved?
Oligio is FDA 510(k) cleared, which is the correct word, not “approved.” The Oligio was cleared as K221989 on 13 October 2022 and Oligio X as K240313 (2024) and K243929 (2025), with Thermage FLX as the comparison machine. The label lists electrocoagulation and hemostasis, not wrinkles.
Is 10Therma FDA approved?
10Therma is FDA 510(k) cleared as K232992, dated 20 December 2023, with Thermage FLX as the comparison machine. Its label lists electrocoagulation and hemostasis, not wrinkles. The file included no clinical trial.
Is XERF FDA cleared?
Yes. Lutronic’s XERF is FDA 510(k) cleared as K251327, dated 11 August 2025, with Thermage FLX as the comparison machine. It has the most detailed file of the three: a side-by-side skin heating-curve test against Thermage FLX. The label does not include wrinkles.
Is Oligio the same as Thermage?
Oligio is not the same as Thermage, but the FDA accepted it as equivalent in technology (K221989). A similar result is a fair expectation, though tip, shots, power and the doctor change it (clinical judgement). Only Thermage FLX (K170758) has a wrinkle line on its US label.
References
- US FDA. 510(k) K170758, Thermage FLX System (Solta Medical), 22 Sep 2017. accessdata.fda.gov
- US FDA. 510(k) K221989, The Oligio (Wontech), 13 Oct 2022. accessdata.fda.gov
- US FDA. 510(k) K243929, Oligio X (Wontech), 21 Jan 2025. accessdata.fda.gov
- US FDA. 510(k) K232992, 10THERMA (Tentech), 20 Dec 2023. accessdata.fda.gov
- US FDA. 510(k) K251327, XERF (Lutronic), 11 Aug 2025. accessdata.fda.gov
- Shin J, et al. Cosmetics 2024;11(3):71. 10.3390/cosmetics11030071
- Baek Y, Nguyen NH, Ham S, et al. Monopolar radiofrequency for facial hyperpigmentation treatment. Int J Mol Sci 2026;27(2):761. 10.3390/ijms27020761
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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