Key takeaways
- Thermage FLX is FDA-cleared, not approved, for wrinkles and rhytids; "tightening" is Solta's word.
- Solta describes one treatment, with results building over months and annual maintenance suggested.
- Do not have Thermage with a pacemaker, defibrillator or other electrical implant.
- Solta publishes no prices; cost depends on the area, and each treatment uses a single-use tip.
- No head-to-head trial compares Thermage with Ultherapy, so comparisons rest on clearances and maker claims.
What is Thermage and how does it work?
Thermage is a brand of radiofrequency skin devices sold by Solta Medical.
The Thermage and Solta Medical brands are trademarks of Bausch Health Companies Inc. or its affiliates, which places Solta inside Bausch Health.
The model Solta describes on its patient website is Thermage FLX.
FDA cleared it through the 510(k) device pathway on September 22, 2017 (K170758) for non-invasive treatment of wrinkles and rhytids — the medical term for wrinkles — including periorbital wrinkles on the upper and lower eyelids, and for electrocoagulation and hemostasis.
With its vibration feature, the device is also cleared for temporary improvement in the appearance of cellulite.
Cleared is not the same as approved: Thermage FLX reached the market through 510(k) clearance, so it is FDA-cleared, not FDA-approved.
The mechanism, as FDA's own documents describe it, is monopolar radiofrequency energy delivered at 6.78 MHz.
Solta describes Thermage FLX as an "FDA-cleared monopolar RF device for the non-invasive treatment of wrinkles" and calls the brand "a pioneer in non-invasive skin tightening." Both descriptions come from the maker, and neither is the cleared wording: the cleared indication says wrinkles and rhytids, not "tightening" or "lifting."
FDA's clearance for Thermage FLX names wrinkles and rhytids, including on the eyelids, plus temporary cellulite improvement with the vibration feature. "Skin tightening" and "lifting" are the maker's language — on this page those words carry Solta's attribution, not FDA's.
What does Thermage treat, and who is a good candidate (and who is not)?
The cleared indication list is short.
FDA cleared Thermage FLX to treat wrinkles and rhytids non-invasively, including periorbital wrinkles on the upper and lower eyelids; to perform electrocoagulation and hemostasis; and, with the vibration feature, for temporary improvement in the appearance of cellulite.
A use that is not on this list is not a cleared use for this device, whatever a treatment menu or an advertisement suggests.
On the "who should not" side, Thermage's safety information is categorical: do not undergo Thermage treatment if you have a cardiac pacemaker, a cardioverter, a defibrillator or any other electrical implant.
The same safety information draws a second, different line — conditions Solta says it has not studied.
That list covers treatment over dermal fillers, pregnancy and breastfeeding, diabetes, autoimmune disease, epilepsy, tattoos and permanent make-up, and children.
Not studied is not the same as unsafe, and it is not the same as cleared for those groups either; it means the company has no data there, and a licensed provider has to judge each case on its own.
Do not treat (stated exclusion)
- Cardiac pacemaker
- Cardioverter
- Defibrillator
- Any other electrical implant
Not studied by Solta
- Treatment over dermal fillers
- Pregnancy and breastfeeding
- Diabetes, autoimmune disease, epilepsy
- Tattoos and permanent make-up
- Children
Thermage's safety information says not to undergo treatment with a cardiac pacemaker, a cardioverter, a defibrillator or any other electrical implant. That is the maker's own instruction, stated as a flat exclusion — mention every implanted device at the consultation.
How much does Thermage cost?
Start with what we could not confirm: a national price.
Solta says Thermage cost "depends on the area you're having treated," and the company does not publish prices.
The American Society of Plastic Surgeons' 2025 statistics release does not report fees for minimally invasive procedures, so no current ASPS average fee exists for Thermage either.
A price on a clinic menu or a promotion is that seller's number, not a market average we can verify.
What the record does show is the cost structure.
Solta ties the cost to the area treated and describes Thermage as a single-treatment procedure, so a practice recommending a package of sessions is a question to explore rather than a given.
Thermage tips are single-use: each tip delivers a set number of pulses and cannot be used once those pulses are spent, so each treatment uses up a tip.
What drives a Thermage quote
| Factor | What the record says |
|---|---|
| Area treated | Cost depends on the area (Solta) |
| Sessions | Described as a single-treatment procedure (Solta) |
| Tip | Single-use; delivers a set number of pulses, then cannot be reused |
| Published price | None from Solta; no current ASPS average fee |
With no verified national figure in our research, the written quote is the number that matters.
Ask each practice to state which area or areas the quote covers, whether any touch-up or second pass is included, and what the total would be if more than one area were treated.
For more on pricing, see how much Thermage costs.
Find Thermage providers near you
Compare Google ratings, reviews and posted prices at med spas in your city.
How many sessions do you need and how long do results last?
Solta markets Thermage FLX as a single-treatment procedure.
The company says some patients notice immediate tightening, that for most patients measurable results appear gradually in the 2 to 6 months after the session, and that results "can last for 1-2 years depending on your skin condition and aging process." Solta also suggests annual maintenance treatments.
Keep the source in view: every timeline in that paragraph is the manufacturer's.
Our research pass found no independent clinical trial data behind a "typical" Thermage result timeline, and none of these figures is a promise for any one person.
How long any improvement holds depends on the skin and on aging — which is why Solta's own framing ends in maintenance.
Does Thermage hurt, and what is the downtime?
Thermage's safety information lists mild-to-moderate pain during treatment among the procedure's effects.
Ask a practice before booking how it manages comfort during the session.
On time, Solta says most treatments take 30 to 60 minutes depending on the area being treated, with little to no downtime and temporary redness that usually resolves within 24 hours.
Both of those are the maker's statements, and the same safety information documents slower recoveries: swelling that usually resolves within 5 days but can last several weeks, and, infrequently, burns.
Both layers come from the same record; the second is the one to plan around.
What are the side effects and risks of Thermage?
Thermage's safety information lists these effects:
- Mild-to-moderate pain during treatment.
- Redness, which usually resolves within 24 hours.
- Swelling, which usually resolves within 5 days but can last several weeks.
- Infrequently, burns with blistering and scab formation, with a possibility of scar formation.
- Infrequently, surface irregularities; numbness, tingling or temporary paralysis; lumps under the skin, mainly on the neck; and skin darkening.
The maker's safety information gives no frequency figures for any of these effects, so treat any percentage you see attached to Thermage elsewhere as unverified.
The maker's safety information says the procedure may produce heating in the upper layers of the skin, causing burns and subsequent blister and scab formation, and that there is a possibility of scar formation. Numbness, tingling or temporary paralysis are also listed. Contact the practice that treated you about any effect that concerns you.
Thermage vs alternatives: which is right for you?
Our research pass located no head-to-head clinical trial comparing Thermage with Ultherapy, so an honest comparison runs on two things: what each device is cleared for, and what each manufacturer says.
On cleared wording, the devices part ways.
Ultherapy and Sofwave both carry FDA clearances to lift the eyebrow and lift lax submental (under-chin) and neck tissue; Thermage FLX's clearance is for wrinkles and rhytids, including on the eyelids — not for "lifting." Ultherapy works by micro-focused ultrasound with real-time imaging.
Sofwave is parallel-beam ultrasound at 10 to 12 MHz focused in the dermis, cleared to improve facial lines and wrinkles and to lift the eyebrow and lax under-chin and neck tissue in adults 22 and older.
Thermage is the radiofrequency option of the three: monopolar RF at 6.78 MHz.
Energy type and cleared wording
| Device | Energy | Cleared wording |
|---|---|---|
| Thermage FLX | Monopolar radiofrequency, 6.78 MHz | Wrinkles and rhytids, including eyelids — not "lift" |
| Ultherapy | Micro-focused ultrasound with real-time imaging | Lift the eyebrow and lax under-chin and neck tissue |
| Sofwave | Parallel-beam ultrasound, 10–12 MHz, focused in the dermis | Facial lines and wrinkles; lift the eyebrow and lax under-chin and neck tissue (adults 22+) |
On maker claims, Solta says Thermage results can last for 1-2 years depending on skin condition and aging; Merz says Ultherapy PRIME face results can hold "a year or more," and gives the abdomen and arms up to 6 months.
Both statements are the manufacturers' own, made about their own devices, and our research located no head-to-head trial behind either claim.
RF microneedling devices such as Morpheus8 sit in a different cleared category — dermatologic procedures requiring coagulation or contraction of soft tissue, or hemostasis — a clearance wording that does not list skin tightening or acne scars. RF microneedling is its own treatment with its own risk profile.
The fuller field — ultrasound, radiofrequency and laser tightening — is compared in our guide to skin tightening options.
Which device suits which face is a conversation for a licensed provider who examines your skin.
The questions worth bringing: which cleared indications cover the area you want treated, which device the practice actually owns, and what evidence stands behind the results the practice shows you.
How do you choose a Thermage provider near you?
Start with the device.
Solta notes that its Thermage before-and-after photos may be a compilation of results from all generations of the device, including NXT, CPT and FLX — so gallery photos may not show the machine a practice owns.
Ask which Thermage generation is in the treatment room, and check the practice's claims about it against the cleared list earlier in this guide.
Then ask who operates it.
AmSpa, a med spa trade association, says injecting botulinum toxin falls under the practice of medicine because an FDA legend (prescription) drug is being used to affect living tissue, so it must be done by a licensed professional acting within their scope, under rules that vary by state.
Thermage is a device rather than an injectable, so the direct questions are who will run the treatment, what that person's license is, and what training they have on this specific device.
Screening is part of quality.
A practice should ask about your medical history before treatment — electrical implants, fillers, pregnancy and the other conditions on the safety list — because the maker's own instructions draw lines there.
If nobody asks, read that as information about the practice.
Photos come next.
Under the FTC's endorsement guides, a result shown in an ad is read as representative of what consumers will generally achieve, and an advertiser whose results are not typical must clearly disclose the results consumers can generally expect — a "results not typical" disclaimer alone is generally insufficient.
Solta's own photos are labeled with treatment counts and time points (its examples run 6 weeks and 3 months after 1 treatment); check any gallery for treatment count, time since treatment, lighting and whether the photos are unretouched.
Finally, money.
Solta publishes no prices, so get the quote in writing, with the areas, the session plan and any touch-up charges spelled out.
Our checklist for how to choose a med spa covers the questions that travel to any treatment, from who owns the practice to what to get in writing.
Frequently asked questions
Is Thermage FDA-approved or FDA-cleared?
Cleared, not approved.
FDA cleared Thermage FLX through the 510(k) device pathway on September 22, 2017 (K170758) for non-invasive treatment of wrinkles and rhytids, including periorbital wrinkles on the upper and lower eyelids, plus electrocoagulation and hemostasis; with its vibration feature it is also cleared for temporary improvement in the appearance of cellulite. "Skin tightening" is Solta's marketing description, not the cleared wording.
How long do Thermage results last?
Solta, the maker, 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 the aging process; the company suggests annual maintenance treatments.
Our research found no independent clinical trial data behind these timelines, so treat them as the manufacturer's claims rather than tested averages for what you will get.
Does Thermage hurt?
The device's safety information lists mild-to-moderate pain during treatment as an effect of the procedure.
Solta says most treatments take 30 to 60 minutes depending on the area being treated.
Ask a practice before booking what to expect for your treated area and what options it offers during the session.
Can you have Thermage with a pacemaker or dermal fillers?
The maker's safety information says not to undergo Thermage with a cardiac pacemaker, a cardioverter, a defibrillator or any other electrical implant — that is a stated exclusion.
Fillers are a different case: Solta says it has not studied treatment over dermal fillers, which is not the same as cleared and not the same as ruled out.
Both belong in the consultation conversation with a licensed provider.
Sources
Every number on this page comes from one of these sources and was checked against it.
- accessdata.fda.gov · U.S. Food and Drug Administration
- Thermage · thermage.com
- Fraxel · fraxel.com
- accessdata.fda.gov · U.S. Food and Drug Administration
- accessdata.fda.gov · U.S. Food and Drug Administration
- Ultherapy · ultherapy.com
- plasticsurgery.org · American Society of Plastic Surgeons
- 16 CFR 255.2 -- Consumer endorsements. · ecfr.gov
- Solta Medical · solta.com
- What Are the Rules for Who Can Inject Neurotoxins? · American Med Spa Association
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.