Aesthetic Product Evidence Index

Approval status

We failed on four or more occasions to obtain the Korean approval number in its original form: automated lookup on the MFDS emedi and udiportal systems and on the manufacturer's Korean site is blocked. Several trade reports state a Korean approval was obtained during 2025 (Smart Today 2025-10-28, MediToday 2026-05-22). Taiwan TFDA 2026-05; European CE.

Human evidence

33 human subjects in total, largest single study 30, longest follow-up 6 months

Design — No controlled trial. One pilot study (30 subjects, 6 months) and three case reports

• Ponzo, PRS Glob Open 2025;13(11), PMID 41210393 — 30 subjects, 6 months
• Brito and Ong, Ann Case Rep 2023;8(4) — 2 subjects, 3 months (12 weeks)
• Dimonitsas 2025 — 1 subject

There is no human histology for liquid PCL.

Preclinical

• Hong 2021, Dermatol Ther 34(2):e14770, PMID 33421287 — rat, 12 weeks. The injected bolus dispersed within 6 hours; no residue and no foreign-body reaction over 12 weeks
• Seo 2026, J Cosmet Dermatol, doi:10.1111/jocd.70950 — 40 rats, photoaging model. Significant increase in dermal thickness and type I collagen at 6 weeks (p<0.001, p=0.003)

Adverse events, with denominators

Reversibility

No known method — PCL is a polyester with ester bonds and is not considered dissolvable by hyaluronidase, but we could not find a study testing this directly for the liquid form. For microsphere PCL there is in-vitro collagenase data.

Sessions and intervals

Manufacturer FAQ, verbatim: "One session is recommended. Optionally, 1-2 follow-up sessions at 4-6 weeks interval." (manufacturer wording)

The widely repeated '3 sessions at 3–4 week intervals' has no primary source we could find, and it is not the manufacturer's default, which is a single session.

Approval status

The manufacturer states explicitly that the L (3 years) and E (4 years) figures are extrapolated from the S and M data. L and E are not approved in Korea.

Approved indication, verbatim

Polycaprolactone is injected subcutaneously to temporarily improve facial wrinkles in adults through physical augmentation

The word 'collagen' does not appear in the approved indication.

Human evidence

13-subject human histology study with within-subject control, plus a 24-month randomised trial of 40

Design — Within-subject untreated control, single clinic

• Kim JS, Aesthet Surg J 2019;39(12):NP484–NP494, PMID 30778526 — 13 subjects. Dermal thickness increased 26.74%±9.26% (1,412.41±69 → 1,781.11±110 µm, p<0.001), ultrasound 21.31%±4.34%. Three subjects had additional biopsies at 2 weeks and 4 years, +48.1%±5.8% at 4 years (P<0.001). Note: the ratio of the two reported means is +26.1%, which does not match the 26.74% printed alongside it. We reproduce the paper's figures as published and leave the discrepancy visible until the original can be checked
• Kim JA and Van Abel 2015 — biopsy showing particle persistence at 13 months, 2 subjects
• 24-month randomised trial, 40 subjects — the comparator was a different formulation of the same PCL

The biopsy site in the 13-subject study was the temple, not the face, with the right side serving as the untreated within-subject control. Fibroblasts, giant cells, new capillaries, new collagen and elastic fibres were observed together around the particles.

Adverse events, with denominators

Reversibility

No (collagenase experimental) — Not dissolvable by hyaluronidase. For microsphere PCL there is in-vitro data showing dissolution in collagenase within 5 minutes (Wu L, J Cosmet Dermatol 2025;24:e70201). That is not in-vivo data, and clinical attempts to dissolve nodules with collagenase remain at the case-series level and are not established.

Approval status

In Korea PN is classified as a medical device, so clinical trial data is in principle required, though it may be waived where substantial equivalence to an existing product is accepted. We did not obtain the approval number in its original form.

Approved indication, as confirmed

Temporary improvement of facial wrinkles in adults through physical augmentation

The word 'collagen' does not appear in the approved indication.

Human evidence

The Korean phase 3 trial (2014) is a retracted paper. What remains is a 30-subject comparison and a 219-subject systematic review

Design — Varies by study, see references

• Pak CS, Heo CY et al., J Korean Med Sci 2014;29(Suppl 3):S201–S209 (Korean phase 3, 72 enrolled / 70 analysed) — this paper was retracted in 2016 (J Korean Med Sci 2016;31:330). The reason for retraction was not data fabrication but incorrect disclosure of funding source and conflicts of interest. We therefore do not publish its improvement-rate or adverse-event figures
• Jeong GJ et al., J Cosmet Dermatol 2020;19(7):1593–1599 — PCL versus PN, 30 subjects, no significant difference between groups
• Lampridou 2025, J Cosmet Dermatol 24(2) — systematic review of PN, 9 studies and 219 subjects. It states that the included studies were of 'low and moderate quality' only and that consensus on optimal use is limited
• The largest comparison in this class (J Cosmet Dermatol 2025;24(1):e16576, PCL versus PN, 218 subjects) was also retracted, in 2026. The reason was not falsified results but misstatement of the composition of the product used

The evidence base for this class has been disturbed twice by retraction. What remains is either small (30 subjects) or rated low in quality (the 219-subject review).

Adverse events, with denominators

Reversibility

No known method — We could not find a primary study of any agent that reverses PN.

Sessions and intervals

3 sessions at 2-week intervals (clinical practice and literature)

The trial usually cited as the source of this schedule is the retracted Korean phase 3. We could not identify the primary basis for the schedule.

Approval status

Classified as a medical device in Korea. We did not obtain the approval number in its original form.

Human evidence

28 subjects, 18 weeks, Antera 3D measurement, single arm

Design — Single arm, no control

• Kim JH et al., Aesthetic Plast Surg 2022;46:1902 — wrinkles p<0.001, haemoglobin improved p<0.05, melanin not significantly changed

The area measured was the lateral canthal region, not the tear trough.

Reversibility

No known method — We could not find a primary study of any agent that reverses PN.

Approval status

hADM is neither a medical device nor a drug in Korea. It is human tissue under the Act on Safety and Management of Human Tissue. Approval is granted to the institution (the tissue bank), not to the product, so no per-product approval number exists; the material may be distributed without clinical trials or product approval; and there is no adverse-event reporting system for it. It is not that no reports exist, but that there is nowhere to report to. The MFDS began reviewing an ECM classification in July 2026.

Human evidence

One of the few boosters with its own controlled human trial: 20 subjects, 20 weeks

Design — Split-face, double-blind, randomised, hyaluronic acid control, three intradermal injections at one-month intervals

• Lee YI, Chau NH, Nguyen NH, Ham S, Baek Y, Kim J, Lee JH. Int J Mol Sci 2026;27(5):2193 / NCT07155278 (Yonsei University, started November 2024, completed May 2025, Phase 4, six co-primary endpoints, results not posted) — density, volume, wrinkles, pores, hydration, TEWL, elasticity and pigmentation all p<0.05, no serious adverse events
• Zhang C et al., Aesthetic Plast Surg 2026;50:3710–3719, PMID 41381953 — Chinese micronised ADM, multicentre double-blind randomised non-inferiority trial, 202 allocated / 175 completed, 6 months, cross-linked collagen filler control. 88.4% versus 85.4% at 3 months, 70.9% versus 69.7% at 6 months

The test arm was not hADM alone but hADM combined with hyaluronic acid, against hyaluronic acid alone. The paper does not name the product; we matched it through the trial registration. Funding and conflicts of interest could not be verified. The trial was conducted after launch (November 2024).

Adverse events, with denominators

Reversibility

No known method — We could not find a primary study of any agent that reverses it.

Sessions and intervals

3 sessions at one-month intervals (trial registry)

Note

Under the US FDA guidance on Minimal Manipulation and Homologous Use (July 2020), example 10-4(b) reads "grinding the dermis into particles … more than minimally manipulated", so a powdered hADM injectable could not be distributed as human tissue in the United States. 21 CFR 1271.10(a) also excludes combination with another substance, which would capture formulations mixed with hyaluronic acid.

Approval status

Classified as human tissue, as with RE2O. No per-product approval number exists.

Human evidence

We could not find a published human trial

This means we could not find one, not that none exists.

Approval status

The MFDS has designated the attachment to the Radiesse approval certificate as non-public.

Approved indication, as confirmed

Temporary improvement of facial wrinkles in adults through physical augmentation

Human evidence

One of the few products with a no-treatment-controlled randomised trial: 152 subjects, 24 weeks

Design — Randomised, no-treatment control. Day 1, week 6 and week 12; 1:2 dilution, 22G cannula

• FDA PMA P050052/S162 (2026), Fabi 2026 — 152 subjects, 71.2% (95% CI 61.4–79.4) versus 6.3% at 24 weeks. On 2026-03-31 the FDA approved Radiesse diluted 1:2 for the décolletage
• Yutskovskaya YA and Kogan EA, J Drugs Dermatol 2017;16(1):68–74 — n=20, ages 35–45, neck and décolletage, biopsy at 7 months. Type I collagen and elastin significantly increased at 4 and 7 months; type III increased at 4 months then decreased at 7
• Zerbinati and Calligaro, CCID 2018;11:29 — 5 women, abdomen, 2 months. Red/orange (which the paper calls mature type I) 40.59% → 15.54%; green/yellow (new type III) 1.76% → 34.42% (p<0.01)
• J Clin Med 2024;13:1686 — review of 13 controlled CaHA studies totalling 1,171 subjects

Zerbinati 2018 is commonly cited as evidence that type I collagen increases, but its actual result points the other way: mature type I fell and new type III rose. Separately, the primary source for the widely quoted '160% increase in total collagen' is a single patient, thigh, lidocaine dilution, and the number itself does not appear in that paper.

Adverse events, with denominators

Reversibility

No — There is no antidote. Yankova, Aesthet Surg J 2021;41(5):NP226 — in cadaveric facial arteries, three concentrations of sodium thiosulphate and a combination with 300 IU hyaluronidase all left CaHA in the artery at 24 hours, and the paper states that we "still lack a suitable antidote". Danysz, CCID 2020 likewise found no sign of degradation. A JAAD 2018 line of work argues the opposite, so the point is disputed.

Sessions and intervals

Expert consensus level (expert consensus)

Note

Of 511 cumulative reports of blindness, CaHA accounts for 1.6% (Doyon, Aesthet Surg J 2024). That is a share of case reports, not a risk figure, because there is no denominator of treatments per product. What can be interpreted is the distribution by site: nose 40.6%, forehead 27.7%, glabella 19.0%, together 87.3%.

Approval status

Nine product names including Volathum and Facetem share this same 2011 approval.

Human evidence

We could not find peer-reviewed clinical literature naming this product; only manufacturer material

This means we could not find it, not that none exists. For class-level CaHA evidence see the Radiesse entry.

Reversibility

No — Same as the CaHA class; see the Radiesse entry.

Approval status

The number 62026-I10-23-2790 on the official site is an advertising review number, not a product approval number. We could not obtain the approval number in its original form, as automated MFDS lookup is blocked.

Human evidence

A paper naming this product does exist: 20 subjects, 12 weeks

Design — Prospective, single arm, open label, no control. Three sessions at 2-week intervals

• Lee JH et al., J Cosmet Dermatol 2024;23(2):409–416, PMID 37705328 (Yonsei Severance) — mean age 54.1. Lemperle 2.60±0.60 → 1.55±0.51 at 8 weeks (a 40% reduction), decreasing to 33% at 12 weeks. One transient subcutaneous nodule

The title of the paper is the answer in itself: "intradermal hyaluronic acid filler as a skin quality booster". The line between filler and booster is drawn by how a product is used, not by what it is.

Reversibility

Yes — As a hyaluronic acid product it can be reversed with hyaluronidase. Of the boosters used at this clinic, this class is the only reversible one.

Approval status

We did not obtain the approval number in its original form.

Approved indication, as confirmed

Temporary improvement of facial wrinkles in adults through physical augmentation

Human evidence

We could not find a clinical trial naming this product. The references below are class-level PDLLA data

Design — Varies by study

• Ting 2024 — randomised, evaluator-blinded, multicentre, 260 Asian subjects, single treatment. Superior to hyaluronic acid as early as 4 weeks, with rapid decline after 24 weeks
• Seo 2026 — 40 subjects, no control group. Continued to rise
• Park JY et al., Skin Res Technol 2026, DOI 10.1111/srt.70324 — PDLLA versus PLLA, 33 subjects, similar degree of improvement

Ting and Seo point in opposite directions, and Ting is the stronger design. A review in Polymers 2024;16:2583 states that for PDLLA there are no RCTs and no human histology at the product-specific level.

Adverse events, with denominators

Reversibility

No known method — That hyaluronidase does not work is inferred from mechanism; we could not find a study testing it directly. In the case of retinal artery occlusion after glabellar injection, hyaluronidase did not work.

Sessions and intervals

As per trial protocols (trial protocol)

Approval status

The Korean official site displays only an advertising review number and not a product approval number. The Korean approval was amended on 2026-05-15 (reconstitution volume 5 mL to 9 mL, use immediately after hydration), per trade press reports.

Approved indication, as confirmed

Poly-L-lactic acid is injected to temporarily improve facial wrinkles in adults through physical augmentation

Human evidence

FDA randomised trial, 149 subjects, 24 months. The largest randomised trial in this class

Design — Randomised, controlled

• FDA PMA P030050/S039 (2023) — 149 subjects, 70.7% versus 25.9% at 12 months (p<0.0001), 76.9% at 24 months
• A 233-subject randomised dataset over 25 months exists, but a 2024 systematic review rated it low quality
• FDA history: 2004-08-03 (HIV lipoatrophy), 2009 (PMA P030050), 2023-04-26 (cheek augmentation)

What 'two years' actually refers to is the label wording: up to 25 months after the last treatment in some patients.

Adverse events, with denominators

Reversibility

No known method — That hyaluronidase does not work is inferred from mechanism; we could not find a study testing it directly. Nodules and papules resolve with conservative management in 85–96% of cases.

Sessions and intervals

Up to 4 sessions at 3-week intervals (FDA 233-subject trial) (approval documentation)

Note

Of 511 cumulative reports of blindness, PLLA accounts for 1.1% (Doyon 2024). That is a share of case reports, not a risk figure: there is no denominator.

Approval status

FDA approved 2023-05-15. It created a new indication, improvement of skin smoothness of the cheeks, and specified the cheek as the treatment area.

Human evidence

FDA label

Design — FDA registration trials

Adverse events, with denominators

Reversibility

Yes — Hyaluronic acid

Note

This product is not used at Miso Clinic. It is included as a reference point, to show how high adverse-event rates for skin boosters become when patients are asked directly.

Approval status

Approved products exist in Korea but we did not obtain any product approval number in its original form; what we verified was the approval date of Tergase, 2024-07-05. Note that the approved Korean indication does not include dissolving filler. It reads only: subcutaneous and intramuscular injection, increased permeation of local anaesthetics and subcutaneous infusions, and promotion of resorption of excess fluid or blood in tissue. All aesthetic use is off-label.

Approved indication, as confirmed

Subcutaneous and intramuscular injection; increased permeation of local anaesthetics and subcutaneous infusions; promotion of resorption of excess fluid or blood in tissue

Human evidence

The drug where practice and evidence diverge most sharply

Design — Meta-analysis, in vitro and practice survey

• Faivre, Aesthet Surg J 2024;44(6):NP402 — in vitro, 16 products, Hylenex 150 U/mL. Belotero Balance 3.6 minutes versus Juvéderm Volux 45.1 minutes, a 12.5-fold difference. The authors conclude that manufacturing technology is the single most important factor
• Flégeau, Molecules 2023;28(3):1003 — split dosing, five doses at 5-minute intervals, reached 90% degradation in 26.2 minutes versus 46.9 minutes for a single dose, a 43% reduction
• Boey, Aesthetic Plast Surg 2024;48:3971 — meta-analysis of 15 studies and 223 patients. Complete resolution 88.1% with low dose (≤500 IU) versus 69.6% with high dose (>500 IU), p=0.18. There is no evidence that a higher dose works better
• Boey 2025, 4 studies and 55 patients — with ultrasound guidance, complete resolution 94.6%, at a mean working dose of 35–60 units
• Currie 2024 — a survey of 264 practitioners, not patients. Skin testing in practice: never 29%, always 25%, sometimes 38%

The conversion rule '5 units per 0.1 mL of HA at 20 mg/mL' contradicts measured data. Units are not equivalent across products (Hylenex 150 U/vial versus Hyalase 1500 IU/vial).

Adverse events, with denominators

Note

That it does not work on PLLA, PDLLA, PCL, PN or hADM is inferred from mechanism; we could not find studies testing this directly. Only for CaHA is there negative experimental data. The practice of waiting two weeks after dissolving is a matter of observational convenience rather than pharmacokinetics: on the CMAC account no enzyme activity remains after 48 hours.

Approval status

No exosome preparation approved for injection has been identified in Korea. MFDS guidance of 2023-01-05 states that intradermal delivery for skin regeneration or wrinkle improvement is permitted only for products approved as drugs or medical devices, and that delivery by syringe or microneedle falls within this, which includes MTS and microneedling. In Seoul Administrative Court case 2024구합53581, decided 2025-04-11, the court upheld a three-month suspension of a physician's licence for injecting by syringe an exosome product approved as a cosmetic, and held that the violation was made out even though no harm came to the patient (we did not obtain the judgment itself and confirmed this through press reports).

Human evidence

The strongest design in the published literature is a 25-subject topical study

Design — Double-blind, randomised, split-face (topical application)

• Kwon HH et al., Acta Derm Venereol 2020;100:adv00310 — acne scarring, 25 subjects, 12 weeks. Applied immediately after three fractional CO2 sessions plus twice daily for 2 days. ECCA reduction 32.5% versus 19.9% (p<0.01). The control side also improved by 19.9%. The paper states directly that the sample size was set on feasibility grounds without a power calculation, and the test material was supplied by the manufacturer
• 2026 systematic review (Dermatol Pract Concept) — 1,032 papers screened, 21 included, of which only one was randomised

ISEV MISEV2023 (J Extracell Vesicles 2024;13(2):e12404) recommends against using the term 'exosome' at all, stating there are no universal molecular markers of ectosomes, exosomes or other EV subtypes. Measured size also varies with the measurement method.

Note

The FDA stated consistently across three documents (2019-12-06, 2019-12-09, 2020-07-22) that there are currently no FDA-approved exosome products. A count of 'hundreds of millions of particles' is not an efficacy measure: particle counters cannot distinguish exosomes from protein aggregates, lipoproteins or viruses. There is no primary source for the claim that exosomes outperform growth factors, and the only direct human comparison (exosome versus PRP) concluded that they were similar, not superior. Miso Clinic uses these preparations topically after laser only and does not inject them.

Approval status

Masseter hypertrophy is an indication Korea approved formally before any other country: a Korean product was approved by the MFDS on 2023-08-25, 48 units over 6 sites, on a domestic phase 3 trial of 180 adults at two university hospitals. This comes from pharmaceutical trade press quoting the manufacturer, a secondary source, and we could not verify the phase 3 paper or its p-values.

Human evidence

FDA registration trials, 405 active versus 132 placebo

Design — Randomised, placebo controlled

• FDA label — onset "one to two days after injection, increasing in intensity during the first week"; duration for the glabellar indication "approximately 3-4 months". At day 30, investigator assessment 80% versus 3% and patient assessment 89% versus 7%
• Rappl 2013 — randomised, double-blind, 180 subjects (60 per group). Median onset 5.29 days in women and 5.89 days in men; median duration 140.65 days in women and 116.61 days in men; sex difference p<0.0001
• Nestor and Ablon 2011 — forehead only, 20 subjects. Complete effect 44–56 days, partial effect 99–145 days
• Carruthers and Carruthers 2005 — men only, 80 subjects, double-blind randomised dose ranging in the glabella at 20/40/60/80 units. Men benefited from a starting dose of at least 40 units, against a standard of 20 units in women, and adverse events also rose with dose

Retreatment "more frequently than every 3 months" has not been clinically evaluated, and the cumulative ceiling is 360 units over 3 months. The practice of reviewing and topping up at 2 weeks has no evidential basis: no trial has compared 2 weeks against 4, and the 2024 Korean expert consensus makes no recommendation on the timing of assessment.

Adverse events, with denominators

Reversibility

Time reverses it — The effect wears off and function returns.

Note

Dose and satisfaction are not proportional: 60% at 40 units versus 39% at 80 units. At 25 units in the glabella the perceived intensity of anger fell by 50.4% while the ability to identify emotions did not change significantly (Wyffels 2020). The literature contains no threshold for the number of units at which a face begins to look frozen.

Approval status

We could not obtain the Korean approval number: automated MFDS lookup is blocked and the manufacturer's official Korean site does not carry it. What we did obtain is the advertising review number only, 범용전기수술기 조합-2024-16-054, valid to 2027-04-22. Medical device advertising in Korea is now self-review rather than prior review: the former prior-review scheme was ruled unconstitutional (Constitutional Court 2020.8.28. 2017헌가35 and others) and self-review took effect on 2021-06-24.

US FDA

Number K251327 · Date received 2025-04-30, decided 2025-08-11 · Decision Substantially Equivalent · Classification GEI, 21 CFR 878.4400, Class II · Predicate Thermage FLX (K170758)

No clinical tests were included as part of this submission.

Indication, verbatim — indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis

The US indication is electrocoagulation and haemostasis, not lifting. 21 CFR 807.97 reads: "does not in any way denote official approval of the device. Any representation that creates an impression of official approval … is misleading and constitutes misbranding." A 510(k) is a determination of equivalence, not an approval, and must not be advertised as one.

Human evidence

One human study naming the product: 20 subjects, 12 weeks, no control group

Design — Single arm, single centre, one treatment

• Hwang JK, Med Lasers 2025;14(1):23–30, DOI 10.25289/ML.24.035 — the text names XERF® (Cynosure Lutronic). n=20 women, ages 28–63, Fitzpatrick III and IV. Blinded evaluators identified the post-treatment photograph correctly in 80% of cases; mean GAIS 2.75/4; patient satisfaction 7.84/10 with every subject at 7 or above; pain VAS 4–5 without anaesthesia; no adverse events. Declared as having no conflict of interest and no funding

Medical Lasers is indexed in KCI and KoreaMed and is not indexed in PubMed/MEDLINE or SCIE. As of September 2026, this is the only human study naming the product that we have verified.

Preclinical

• Five preclinical papers exist, but all are either authored by manufacturer staff or company-funded: Hong J, Skin Res Technol 2024;30(6); Park C, J Cosmet Dermatol 2024;23(12):3955–60; Ko K, Lasers Med Sci 2025;40:501; Hong J, Med Lasers 2025;14(4):215–22; Ryu HG, Lasers Med Sci 2026;41:111
• Ko 2025 — 2 MHz reached wider and deeper into the fat layer while 6.78 MHz was localised along the fibrous septa. No adipocyte death (TUNEL). Surface kept below 42–45℃. Note that only one tip size (20×30 mm) was used, so this describes frequency and is not a comparison of tip sizes

Approval status

The product approval number does not appear in the official material.

Human evidence

16 subjects, no control group

Design — Single arm

• J Cosmet Dermatol 2025, n=16 — 3D imaging 0.82±0.36 mm, p=3.5×10⁻⁷

All three human papers on this device share the same author, a Jeisys consultant (Kumar).

Note

The real-time skin temperature display is confirmed in two official manufacturer sources (jeisys.co.kr and densityrf.com). However, neither explains the measurement site or the sensor method, so what is verified extends only as far as 'displays epidermal temperature in real time'.

Approval status

MFDS approval dated 2023-09-01. The number cannot be retrieved by automated lookup because the MFDS search screen uses a CAPTCHA. It has to be looked up by a person at emedi.mfds.go.kr, by product name The Great RF Sonata or by company name Wontech with the approval date 2023-09-01.

Human evidence

We could not find a human study of Oligio KISS itself

We searched PubMed, KoreaMed and ClinicalTrials.gov. The two studies commonly cited as the reference work on combined HIFU and monopolar RF were not carried out with Wontech devices: the Soonchunhyang study (Med Lasers 2023) used a Tentech device and the Malaysian study (MJMS 2024) a Jeisys device. They must not be used as evidence for Oligio KISS. The material known as the 'ASLMS 2024 abstract' has already been published in full (Lee SK et al., Med Lasers 2023;12(4):237-242), where the difference between groups was p=0.7373 and not significant.

Note

Do not cite Skin Res Technol 2024;30(2):e13593 (PMID 38279602). It is a retracted paper.

Approval status

We did not obtain the approval number in its original form.

Human evidence

20 subjects, 24 weeks. A study that declares no external funding and no conflict of interest

Design — Single arm, one treatment, three blinded evaluators, weeks 4, 12 and 24

• Shin JM et al., Cosmetics 2024;11(3):71 — n=20 women, ages 42–60. Jawline and nasolabial folds significant at 12 weeks (p<0.05); cheek elasticity from week 4 (p<0.01). Pores, fine lines and skin tone were not significantly changed from baseline. Pain 0.4/10, no adverse events
• Wanitphakdeedecha R et al., Dermatol Ther (Heidelb) 2022;12:2563–2573 — 4 cm², 412±49 shots, 3–4 passes with 15–30% overlap, total 31±4.7 kJ
• A 2022 study in 30 Asian subjects — no pigmentation and no serious adverse events, with a target heat sensation of 3/10

There is no control group.

Approval status

We did not obtain the Korean approval number in its original form.

US FDA

Number K170758 (earlier ThermaCool TC K021402)

no clinical testing statement

This is the predicate device for the XERF 510(k).

Human evidence

The '900 shots' figure is not a clinical dose but the result of a survey

Design — Survey and case series

• Suh DH et al., Dermatol Ther 2017;30(5):e12536 — in a survey of 82 physicians, 86.3% agreed that 900 shots is appropriate for the face in patients aged 35–65. The 2020 follow-up (33(6):e14284) found 86.5% of 52 physicians preferred a 600 REP 4 cm² tip
• Suh DH et al., Lasers Med Sci 2025;40:530 — FLX 0.25 cm² eye tip, 225 shots per eyelid, 450 shots for both eyes, 7–10 passes per eye
• Chilukuri and Lupton, JDD 2017;16(12):1262–6 — measured cooling, dermis 65–75℃ and epidermis 40℃

The 300/600/900-shot price tiers seen in the market are not clinical doses but the tip specifications purchased. The Thermage CPT Technical User's Manual (Solta, 2021, NP009240-06) p.30 states "The number of REPs delivered varies widely (100-2000) based on the size and cooling profile of the Treatment Tip in use" — in a passage about cryogen canister consumption — and the manual gives no recommended total REP count for the face or body. The treatment endpoint on p.49 is "until the patient reports heat feedback of 2.0–2.5 on a scale of 0 to 4". There is not a single study comparing tips.

Adverse events, with denominators

Approval status

We did not obtain the Korean approval number in its original form.

Human evidence

31 subjects, split-face randomised. One of the few trials comparing tip sizes head to head

Design — Split-face randomised, 3 cm² versus 4 cm², 300 shots each, 3 months

• Yang YS et al., J Clin Aesthet Dermatol 2024;17(2):20–22 — 16.4 and 16.6 J/cm². The difference between tips was p=0.845 and not significant. The paper concludes in its discussion that the smaller tip was better for the upper face and the larger tip for the lower face, but that statement goes beyond the data presented. One mild erythematous burn on the forehead with the 4 cm² tip

The original paper carries a unit error, printing 16-19 kJ/cm² and 16.4 J/cm² in the same sentence.