How large are Ulthera effects?
Ulthera is a procedure that uses ultrasound energy to improve mild facial laxity, and the magnitude of change confirmed in studies was on the order of millimeters. Brow elevation was 0.47~1.7mm, and the largest value, 1.7mm, was measured 3 months after treatment.
The use described in US clearance documents is a “temporary change” in the appearance of the skin.
The last time point at which human studies confirmed results was day 360.
In addition to pain, burns, paresthesia, and periocular thermal injury have been reported.
What studies confirmed is that measurable change occurred with a non-surgical device. Ultrasound energy is delivered below the skin, but the nature of the result differs from surgically pulling up lax tissue.
Cleared sites and the changes that can be expected
In the United States, treatment sites were added in the order of the brow, the submental area and neck, then the décolleté. The use written in recent documents is “a temporary change in the appearance of the skin.” Sites cleared in the United States do not automatically carry over as the range available in Korea, so actual treatment areas should be confirmed separately in consultation.
| Year | What was added to the clearance |
|---|---|
| 2009 | This class of device was first classified in the United States |
| 2012 | Brow, then submental area and neck |
| 2014 | Décolleté (below the neck, upper chest) |
| Recent | The use the documents describe is a temporary change in the appearance of the skin |
Ulthera is also distinct from ultrasound surgical devices used in cancer treatment. Which area is treated, and for what purpose, matters as much as the device name.
Ultrasound energy is delivered to match skin depth
Ulthera focuses ultrasound energy into small points and heats tissue. The part that contacts the skin, the transducer, is divided by the depth at which energy concentrates, and it is used while confirming structures under the skin with ultrasound imaging.
In tissue studies, elongated, point-shaped thermal changes formed at depths of 1.5·3.0·4.5mm, and collagen at those sites was seen to have changed. These are findings observed in tissue. How much the face actually lifts should be judged from photographs and measurements taken in people. The authors of this tissue study were employees of an affiliate of Merz, the manufacturer of Ulthera.
At the heated sites, remodeling of the tissue was observed from around day 28. The increase in elastin was not a comparison with before treatment, but a comparison of day 14 and day 90 after treatment.
Changes measured in studies concentrated on the brow and the submental area
An independently conducted literature review included 16 studies that confirmed follow-up of 3 months or more after a single treatment. Subjects were mainly people with mild to moderate laxity, and most participants were adult women.
| Assessment item | Observed result | What to keep in mind when reading |
|---|---|---|
| Brow position | 0.47~1.7mm elevation | The largest value was measured at 3 months |
| Submental change | Submental shadow reduced on profile photos | Measured on planar photos, not 3D volume |
| People whose brows rose more than 0.5mm | 35% at 3 months | Result based on a threshold set in one study |
| Investigator assessment | 92% improved at 90 days among 337 people | Investigators rated photographs |
| Patient assessment | 42% improved at 90 days and 53% at 360 days among 81 people | The degree of improvement was recorded as mild |
92% and 42% come from assessments of different people. They are not numbers from investigators and patients each rating the same group. Measured results at 6 months also differed depending on the direction in which energy was delivered. In consultation, it is therefore more practical to confirm how treatment areas and energy direction are decided than to focus on average figures.
Duration data go through day 360
Among the included studies, only one presented 6-month numbers, and the 360-day results were self-assessments from 81 patients. Within the range confirmed by the independent review, changes continued for up to 1 year, and follow-up data end at that point.
A 2025 review supported by Merz also stated that effects continued through 6 months. However, the way studies were selected differed from the independent review. When comparing duration, it is useful to look together at the last time point that was actually measured.
Adverse reactions to review together with pain
Studies recorded treatment pain as moderate, and many cases used topical anesthetic ointment or systemic analgesics. Redness and swelling after treatment were observed in nearly all of 573 people. Other adverse reactions were reported in 14 people.
Reported cases were 4 bruises, 4 temporary paresthesias, 2 burns, 2 white linear scars remaining on the neck, 1 raised mark on the cheek, and 1 millet-like white bump on the neck. How long the paresthesia took to resolve was not confirmed in those data.
In 2025, a case was reported of a 32-year-old woman who developed eye pain and reduced vision during a facial treatment. After treatment of intraocular inflammation, vision returned, but a white corneal opacity remained permanently. A single-person case shows that the risk exists, more than it shows how often it occurs. If treating areas near the eyes, eye protection, energy upper limits, and stop criteria should be confirmed.
The literature recommends carefully judging whether to proceed when subcutaneous fat is thick or laxity is very severe. For people with very severe laxity, the study authors presented surgical methods as a more suitable option. General contraindications and how adverse reactions are handled can also be reviewed in the treatment safety information.
Area, depth, and sessions are decided in consultation
Study results concentrated on the brow and the submental area, but in actual treatment the depth and energy direction used differ by site. Confirm the following items during consultation.
- □ Device name and model: What device and model will be used today?
- □ Treatment area: Which of the brow, submental area, neck, and décolleté will be treated?
- □ Scope of use: How are the US clearance indications distinguished from the range treated in Korea?
- □ Transducer: Which depths will be used by area?
- □ Shot count and estimate: How are the total number of lines and the allocation by area reflected in the estimate?
- □ Periocular protection: Will eye protection be used? What are the energy upper limits and stop criteria?
- □ Pain management: What anesthesia method is used, and what are the criteria for adjusting energy during treatment?
- □ Next session: Will results be reassessed with photos under the same conditions or with measurements by area?
Items to check when comparing shot counts and area-by-area estimates are set out in the dermatology price comparison guide. Treatment range and process can be reviewed further in the Ulthera treatment information.
Frequently asked questions
Q1. When are Ulthera effects confirmed?
Studies confirmed results at 3 months, 6 months, and 12 months. Follow-up photos should be taken with the same lighting and angle as before treatment so the size of the change is easier to compare.
Q2. How long do Ulthera effects last?
In the independent review, the last time point at which actual results were confirmed is day 360. When duration is explained, also confirm whether there is a study that directly measured that period.
Q3. How many sessions are needed?
All 16 papers in the review measured change after a single treatment. Cumulative results after multiple sessions were not included, so the number of repeats and the interval should be decided after reviewing photos of the previous treatment and change by area.
Q4. Does Ulthera hurt a lot?
Studies recorded pain as moderate, and many cases used topical anesthetic ointment or systemic analgesics. During consultation, confirm the anesthesia method and the criteria for adjusting energy when pain is severe.
Q5. Can it be done when laxity is severe?
Study results mainly cover mild to moderate laxity. There were reports that the amount of improvement decreased as laxity became more severe, and in very severe cases surgical methods were presented as a more suitable option. Methods that insert threads and pull work on a different principle and can be compared separately in the thread-lifting effects and types guide.
Results, duration, and suitability vary with individual skin condition, age, and lifestyle, and the same outcome cannot be guaranteed.
Procedures may cause temporary redness or swelling, and contraindications may apply, so please confirm these during your consultation.
This article is general information and does not replace individual medical care. Please confirm diagnosis and treatment suited to your condition during a consultation.
Sources
- FDA K122528 — Full 510(k) summary and Indications for Use confirmed. Brow-lift indication. A regulatory document, not a comparative clinical efficacy trial.
- FDA K121700 — Full 510(k) summary and Indications for Use confirmed. Submental and neck indications. Not a study that calculated duration.
- FDA K134032 — Full 510(k) text confirmed. Décolleté indication, 10-1.5·7-3.0·4-4.5 transducers, maximum 8mm imaging depth. Does not compare clinical results by energy.
- FDA K233996 — Full intended use text confirmed. Language of temporary change in the appearance of the skin. Does not present a specific duration.
- Korean Law Information Center, “Regulations on Medical Device Categories and Grades by Category,” Appendix 1 (administrative rule serial number 2100000275656) — Full appendix PDF confirmed. A35100.03 category name, Class 3, definition. This document does not contain an individual Ulthera clearance number. In the United States it is classified as Class II and treated as a different category from high-intensity focused ultrasound surgical devices used in cancer treatment.
- PMID 36674277 — Full paper confirmed. A single-session systematic review that selected 16 of 693 papers. Selection criteria were follow-up of 3 months or more, 10 or more participants, and study-design criteria. 90% or more of subjects were adult women. Brow elevation of 0.47~1.7mm; submental area on profile photos reduced by 26~45mm². Brow lift exceeding 0.5mm was 35% of subjects at 3 months. Investigator assessment was 92% improved at 90 days in n=337; patient self-assessment was 42% at 90 days and 53% at 360 days in n=81, with the degree of improvement described as mild. Six-month measurements by energy direction were 5.6~7.2% in the superolateral direction and 1~3.7% in the horizontal direction. There was 1 study with 6-month measurements, and the 360-day data were patient self-assessments from 81 people. Caution is advised for BMI exceeding 30, excessive subcutaneous fat, and very severe laxity. Temporary erythema and edema were observed in nearly all of 573 people, and adverse reactions in 14 people (2%) were reported, including 4 bruises, 4 temporary paresthesias, 2 burns, 2 white linear scars, 1 wheal, and 1 millet-like white lesion. Mainly 2D photographic measurement, with no long-term follow-up data. No external research funding or author conflicts of interest.
- PMID 39545626 / PMC11743342 — Full paper confirmed. Tissue was heated to about 60~70℃, and thermal coagulation points and collagen change were confirmed at focal depths of 1.5·3.0·4.5mm. Tissue remodeling began around day 28, and the increase in elastin was a day-90 change compared with day 14, not versus before treatment. A histologic study, not a clinical efficacy trial, and the authors were employees of a Merz affiliate.
- PMID 40847904 / PMC12374570 — Full paper confirmed. A description of mechanism and duration covering 67 of 703 papers. States that effects continued after 6 months. A narrative review in a supplement issue, not a systematic review, with Merz support and author conflicts of interest.
- PMID 41367308 / PMC12690343 — Full abstract confirmed. A case of a 32-year-old woman who developed iridocyclitis and permanent corneal leukoma after facial MFUS. Vision recovered after treatment, but corneal opacity remained. A single case, so incidence cannot be estimated.
Related reading
Sources
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