Key takeaways
- Thermage FLX is monopolar radiofrequency; Ultherapy is micro-focused ultrasound with real-time imaging.
- Ultherapy's FDA clearance uses the word “lift”; Thermage FLX's clearance covers wrinkles and rhytids.
- Both are cleared devices, not FDA-approved, and no head-to-head trial was found.
- Each maker describes a single-session treatment, and there is no current national price we can cite for either.
- Both carry screening lists, such as electrical implants for Thermage and anticoagulants for Ultherapy.
How RF and ultrasound differ
Thermage FLX and Ultherapy treat the skin with two different kinds of energy, and FDA's own device records describe the difference.
In the comparison table FDA used when clearing a newer radiofrequency device, Thermage FLX is listed as monopolar radiofrequency at 6.78 MHz; FDA's documents describe the Ulthera System as micro-focused ultrasound.
FDA's records describe each device's energy differently, and it has cleared different uses for each.
Ultherapy's clearance also includes something the Thermage FLX cleared description we reviewed does not: imaging.
FDA's Ulthera clearance incorporates the DeepSEE transducer, which shows the provider a real-time ultrasound view of tissue up to 8 mm below the skin surface, to confirm the handpiece is coupled to the skin and treating at the intended depth.
We could not confirm the treatment depths Ultherapy's handpieces use from a primary source we could review, so ask your provider what depth their protocol targets.
Neither device is approved like a drug: both are cleared medical devices, and a clearance attaches to specific uses, word for word.
That wording is where the real Thermage-versus-Ultherapy difference lives.
Which lifts, which tightens?
Start with the cleared wording, because that is the part FDA actually signed off on.
The Ulthera System — the device behind the Ultherapy brand — was first authorized through FDA's De Novo pathway on 11 September 2009, and its current 510(k) clearance (K260618, dated 21 May 2026) covers lifting the eyebrow, lifting lax (loose) submental (under-chin) and neck tissue, improving lines and wrinkles of the décolleté (the chest below the neck), and improving skin laxity on the abdomen, the front and back of the arms, and the knees.
Thermage FLX's clearance (K170758, dated 22 September 2017) is written differently: non-invasive treatment of wrinkles and rhytids — the clinical term for wrinkles — including periorbital wrinkles on the upper and lower eyelids, plus electrocoagulation and hemostasis (coagulating tissue and controlling bleeding).
With its vibration feature, it is also cleared for temporary improvement in the appearance of cellulite.
So the word “lift” sits in Ultherapy's cleared uses, and it does not sit in Thermage FLX's.
Solta markets Thermage as “a pioneer in non-invasive skin tightening,” but its cleared text says wrinkles — not tightening, not lifting.
That is not a verdict on either device — the two lists are simply worded differently.
| Thermage FLX | Ultherapy (Ulthera System) | |
|---|---|---|
| Energy (FDA documents) | Monopolar radiofrequency, 6.78 MHz | Micro-focused ultrasound |
| FDA authorizations | 510(k) K170758, 22 September 2017 | De Novo DEN080006, 11 September 2009; current 510(k) K260618, 21 May 2026 |
| Cleared uses | Wrinkles and rhytids, including upper and lower eyelids; temporary improvement in cellulite appearance (vibration feature) | Lift eyebrow; lift lax submental and neck tissue; décolleté lines and wrinkles; skin laxity on abdomen, front and back of arms, knees |
| Imaging | Not named in the cleared description we reviewed | DeepSEE real-time ultrasound to 8 mm |
Pain and sessions
Both makers put pain near the top of their own side-effect lists.
Thermage's safety information lists mild-to-moderate pain during treatment, and describes redness that usually resolves within 24 hours and swelling that usually resolves within 5 days but can last several weeks.
Merz says the most common side effects reported in Ultherapy's clinical trials were redness, swelling, pain and transient (temporary) nerve effects.
On recovery, both sites lead with reassurance, and each should be read alongside its own side-effect list: a testimonial on Ultherapy's site calls the treatment “zero downtime,” and Solta says Thermage involves “little to no downtime.” Both phrases are the makers' own marketing, and neither side-effect list is empty.
On visits, each maker describes a one-session treatment.
Solta calls Thermage FLX a single-treatment procedure and says most treatments take 30–60 minutes depending on the area, with annual maintenance treatments suggested.
Merz calls Ultherapy PRIME a single-session treatment.
Candidacy is a medical screen, not a formality.
Thermage's safety information says not to have the treatment if you have a cardiac pacemaker, cardioverter, defibrillator or any other electrical implant; Solta also says it has not studied Thermage over fillers, in pregnancy or breastfeeding, in diabetes, autoimmune disease or epilepsy, over tattoos or permanent make-up, or in children. “Not studied” is different from “contraindicated” — it means the maker has no studies, a specific question for your provider.
The Ulthera instructions for use carry their own list: the device has not been evaluated over dermal fillers, over mechanical implants or breast implants, in patients on anticoagulants, in pregnant or breastfeeding women, in children, or in people with conditions including bleeding disorders, herpes simplex, autoimmune disease, diabetes, epilepsy or Bell's palsy — a second list to put to your provider.
Thermage: screening points
- Do not have it with a pacemaker, cardioverter, defibrillator or other electrical implant
- Not studied over fillers or over tattoos or permanent make-up
- Not studied in pregnancy or breastfeeding, or in children
- Not studied in diabetes, autoimmune disease or epilepsy
Ultherapy: screening points
- Not evaluated over dermal fillers, mechanical implants or breast implants
- Not evaluated in patients on anticoagulants
- Not evaluated in pregnant or breastfeeding women, or in children
- Not evaluated in bleeding disorders, herpes simplex, autoimmune disease, diabetes, epilepsy or Bell's palsy
Thermage's safety information says the procedure may produce heating in the upper layers of the skin, causing burns with blistering and scab formation and possible scarring, and lists — infrequently — surface irregularities, numbness or tingling, temporary paralysis, lumps under the skin (mainly the neck) and skin darkening. Ultherapy's trials reported transient nerve effects. The side-effect lists we reviewed give no rates.
Cost
There is no current national price for either device that we can cite.
ASPS's 2025 procedural statistics release does not report counts or fees for minimally invasive procedures, so no current ASPS average fee exists for Thermage — and no verified national figure for Ultherapy turned up in our research either.
How the bill is built, from the makers' own pages: Solta says Thermage cost “depends on the area you're having treated” and does not publish prices.
One structural driver on the Thermage side is the hardware — Thermage tips are single-use, each delivering a set number of pulses before it is discarded.
Across the devices our pricing research covered, the number of sessions a treatment plan calls for is a main price driver; since each maker here describes a single-session treatment, both come as a per-treatment quote rather than a series price — ask exactly what it covers.
For the Ultherapy side on its own, the Ultherapy cost page lays out how its pricing is put together.
Whichever device you price, the useful questions are the same: which areas the quote covers, and — since Solta suggests annual Thermage maintenance — what a maintenance session would cost.
Which to choose
There is no head-to-head study to settle this: our research pass located no clinical trial comparing Thermage with Ultherapy, and the comparisons that do exist rely on each device's own clearances and maker statements.
What you can do is match the cleared uses to the area you want addressed.
Lifting the eyebrow or lax under-chin and neck tissue is in Ultherapy's cleared language.
Wrinkles and rhytids, including on the upper and lower eyelids, and a temporary improvement in the appearance of cellulite are in Thermage FLX's.
Lines and wrinkles on the décolleté and skin laxity on the abdomen, arms or knees are named in Ultherapy's clearance; the Thermage FLX clearance text we reviewed does not mention skin laxity.
Manufacturer duration claims are not a tiebreaker, because they are not like-for-like numbers.
Solta says that for most patients, measurable results appear gradually in the 2 to 6 months after a single treatment and “can last for 1-2 years,” depending on skin condition and aging, with annual maintenance suggested.
Merz says Ultherapy PRIME results “can last up to 6 months for the abdomen and arms and a year or more in the face.” Different makers, different areas, different phrasing — treat each as that maker's claim about its own device, not a measured comparison.
What each maker says about sessions and duration
| Thermage FLX (Solta) | Ultherapy PRIME (Merz) | |
|---|---|---|
| Sessions | Single treatment; annual maintenance suggested | Single session |
| Maker's duration claim | Results appear gradually over 2–6 months and “can last for 1-2 years” | “Up to 6 months for the abdomen and arms and a year or more in the face” |
The deciding input is an examination you cannot do yourself: how loose the tissue is, your medical history, and whether anything on the safety lists above — a pacemaker or other electrical implant, for example — applies to you.
A licensed provider who examines the area can tell you which device fits your case, and it is worth consulting more than one practice before booking either.
Frequently asked questions
Are Thermage and Ultherapy FDA-approved?
Neither one is FDA-approved — both are devices, and devices go through FDA's clearance process, which covers specific uses word for word.
Thermage FLX is cleared under 510(k) K170758 (22 September 2017) for non-invasive treatment of wrinkles and rhytids, including periorbital wrinkles on the upper and lower eyelids.
The Ulthera System was first authorized through De Novo DEN080006 on 11 September 2009, and its current 510(k) clearance, K260618 (21 May 2026), includes lifting the eyebrow and lax submental and neck tissue.
Which lifts better, Thermage or Ultherapy?
On cleared wording, Ultherapy is the device whose FDA clearance uses the word lift — for the eyebrow and for lax submental (under-chin) and neck tissue.
Thermage FLX's cleared text covers wrinkles and rhytids, not lifting, although Solta markets it as a pioneer in non-invasive skin tightening.
We found no head-to-head trial comparing results in our research pass, so which fits you better is a question for a provider who examines your tissue.
Is Thermage or Ultherapy more painful?
There is no head-to-head comparison of pain we can cite.
Each maker's own list puts pain up front: Thermage's safety information lists mild-to-moderate pain during treatment, and Merz says pain was among the most common side effects in Ultherapy's clinical trials, alongside redness, swelling and transient nerve effects.
Ask any practice you consult what numbing or comfort measures they use and how they handle discomfort during the session.
How much do Thermage and Ultherapy cost?
There is no current national average to quote: ASPS's 2025 statistics release reports no fees for minimally invasive devices, so no ASPS figure exists for Thermage, and no verified national figure for Ultherapy turned up in our research.
Solta says Thermage cost depends on the area treated and does not publish prices; its tips are single-use, and each maker describes a single-session treatment, so both come as per-treatment quotes.
Get written quotes covering the same areas from each practice you are considering.
Sources
Every number on this page comes from one of these sources and was checked against it.
- ultherapy.com · ultherapy.com
- accessdata.fda.gov · U.S. Food and Drug Administration
- Thermage · thermage.com
- accessdata.fda.gov · U.S. Food and Drug Administration
- Ultherapy · ultherapy.com
- plasticsurgery.org · American Society of Plastic Surgeons
- accessdata.fda.gov · U.S. Food and Drug Administration
Medical disclaimer. MedSpaStandard is for education only and is not medical advice. Talk to a licensed provider about your own health, and check any provider's license with your state board.