Key takeaways
- XERF is a monopolar RF device from Cynosure Lutronic, 510(k)-cleared in August 2025 for electrocoagulation and hemostasis.
- Its clearance does not mention skin tightening, wrinkles or lifting.
- We could not confirm a XERF price, session count or results timeline. Thermage FLX figures are Solta's claims for its own device.
- Ultherapy and Sofwave are cleared to lift the eyebrow and lax submental and neck tissue. Thermage FLX's clearance says wrinkles.
- Ask who operates the device, what license they hold, and what adverse events its labeling lists.
What is XERF and how does it work?
XERF is a monopolar radiofrequency (RF) device made by Lutronic, now Cynosure Lutronic.
FDA cleared it through the 510(k) pathway on 11 Aug 2025, under number K251327, as an electrosurgical unit.
The clearance names Solta Medical's Thermage FLX as its predicate — the device already on the market that FDA used as the comparison in its review.
FDA's 510(k) summary describes the technology: monopolar RF at two frequencies, 2 MHz and 6.78 MHz, delivered non-invasively into the skin through the tip of a handpiece, with a return pad placed on the patient's back.
The device was reviewed with 12 handpiece tip types.
That two-frequency design is the basis of the "multi-frequency monopolar RF" phrasing in XERF marketing, and it is the main technical difference from the predicate, because Thermage FLX delivers 6.78 MHz only.
Two words matter when you read about this device.
First: XERF is cleared, not FDA-approved — and the same is true of every device in this guide's comparison table: their FDA records are 510(k) clearances and, for Ultherapy's first authorization in 2009, a De Novo.
Second: the cleared indication is narrow.
K251327 clears XERF for "use in dermatologic and general surgical procedures for electrocoagulation and hemostasis," which means using RF current to coagulate tissue and control bleeding.
The clearance text does not mention skin tightening, wrinkles or lifting.
XERF's 510(k) covers electrocoagulation and hemostasis in dermatologic and general surgical procedures. Skin tightening, wrinkles and lifting appear nowhere in it. If a menu or ad describes XERF as FDA-cleared for skin tightening, that is not what the clearance says.
What does XERF treat, and who is a good candidate?
On its clearance, XERF treats one thing: electrocoagulation and hemostasis in dermatologic and general surgical procedures.
A cosmetic use — tightening, wrinkle treatment, lifting — is a use its 510(k) does not cover, so there is no FDA-reviewed indication behind it.
The gap shows up as soon as you look for a candidate profile.
A device cleared for a cosmetic indication comes with a studied population: Sofwave's clearance covers improving facial lines and wrinkles and lifting the eyebrow and lax submental and neck tissue in people 22 and older, and Ultherapy's current clearance names the areas it covers, from the eyebrow and neck to the décolleté, abdomen, arms and knees.
XERF's clearance names no cosmetic use, so it defines no cosmetic study population either.
Sofwave's clearance
- Improving facial lines and wrinkles
- Lifting the eyebrow
- Lifting lax submental and neck tissue
- People 22 and older
XERF's clearance
- Electrocoagulation and hemostasis
- Dermatologic and general surgical procedures
- No cosmetic use named
- No cosmetic study population defined
We also could not verify any manufacturer-published candidacy criteria for XERF — no age range, skin-type limits or exclusion list — because the maker's public site was not accessible when we researched this page.
So this page can't tell you who is a good candidate; that assessment belongs to a licensed provider who examines your skin and history.
In a consultation, three questions cover the public record: which cleared indications the clinic uses XERF under, which uses go beyond the 510(k), and what published evidence they can show for the results they describe.
The FDA file will not answer them; only the clinic can.
How much does XERF cost?
We could not confirm a price for XERF from any source in our research, so this page has no dollar figure — read any single number you find online as one clinic's price, not a confirmed market rate.
The national fee trackers don't fill the gap: ASPS's 2025 statistics release reports no fees for minimally invasive procedures at all, which is why there is no current ASPS average fee for devices like Thermage or Sofwave either.
What we can describe is what drives price across this device family.
The number of sessions is a main price driver, and makers' stated norms vary widely — from Thermage's typical single session (Solta) to the 4–6 sessions Solta says produced visible results for Clear + Brilliant.
Consumables matter too: Solta says Thermage's tips are single-use, each delivering a set number of pulses and then no longer usable, so a new tip is part of every treatment's cost.
Since we can't quote XERF pricing, here is what to put into a quote request instead: whether the price is per session, per area or a package; how many sessions the clinic's protocol assumes; whether maintenance sessions are part of the plan; and what is bundled, from numbing to any single-use tips.
With no published price to check against, more than one consultation is the only real comparison you can make.
How many sessions do you need and how long do results last?
For XERF itself, we have nothing verified to give you: no session count, no treatment timeline and no duration figure appeared in our research.
The 510(k) document states an indication, not results, and we found no clinical trial data and no manufacturer timeline we could read — the maker's site was not accessible when we researched this page.
The nearest published anchor is the predicate device, and it is an anchor for Thermage FLX, not for XERF.
Solta says Thermage FLX is a single-treatment procedure, that some patients notice immediate tightening with gradual improvement over 2–6 months, and that results "can last for 1-2 years" depending on skin and aging, with annual maintenance suggested.
Those are Solta's claims for its own device; sharing a regulatory review does not transfer them to XERF.
For scale, here is what each maker says about its own device: Thermage is typically a single session (Solta), Sofwave is typically one 30–45-minute session (Sofwave), Halo 1–2 treatments (Sciton), Fraxel can take up to 5 (Solta), Clear + Brilliant showed visible results after 4–6 in studies Solta cites, Moxi is 2–4 (Sciton), and Merz calls Ultherapy PRIME a single-session treatment.
None of these numbers is a XERF number.
Session counts, per each maker (none are XERF numbers)
| Device | Sessions, per maker | Source |
|---|---|---|
| Thermage FLX | Typically a single session | Solta |
| Sofwave | Typically one 30–45-minute session | Sofwave |
| Halo | 1–2 treatments | Sciton |
| Fraxel | Up to 5 | Solta |
| Clear + Brilliant | 4–6 for visible results | Solta |
| Moxi | 2–4 | Sciton |
| Ultherapy PRIME | Single session | Merz |
Ask any clinic you consult how many sessions its XERF protocol assumes, when it expects visible change, and what maintenance it recommends — and get the answers in writing before you book.
Does XERF hurt, and what is the downtime?
No XERF-specific pain score or recovery timeline surfaced in our research, so we can't tell you what a session feels like.
The makers of the devices around it do publish statements, and they are worth knowing as makers' statements only.
Solta says most Thermage FLX treatments take 30–60 minutes depending on the area, describes downtime as little to none, and says temporary redness usually resolves within 24 hours; its safety information lists mild-to-moderate pain during treatment.
Sofwave, for its part, lists significant pain among the potential adverse events of its ultrasound treatment.
That downtime figure is Solta's claim about its own device, not an independent finding — and none of these statements describes XERF.
Put the pain question to the clinic directly: whether numbing is used, how long the appointment runs for your area, what the treated skin usually looks like the next day, and when they tell patients to resume makeup, exercise and work.
A clinic that has actually performed the treatment will have its own answers to all four.
What are the side effects and risks of XERF?
Our research captured no adverse-event list, no rates and no case reports for XERF itself.
That absence is a gap in what our research could reach, not a safety finding, and it points to the single best question to put to a provider before booking: what adverse events does the device's own labeling list, and how often does your team see them?
What the neighboring devices publish shows the kinds of effects this energy class can cause.
Thermage's safety information lists mild-to-moderate pain during treatment; redness that usually resolves within 24 hours; swelling that usually resolves within 5 days but can last several weeks; and, infrequently, burns with blistering or scabbing and possible scarring, surface irregularities, numbness or tingling or temporary paralysis, lumps under the skin (mainly the neck) and skin darkening.
Sofwave lists significant pain, tenderness, changes in skin pigmentation, persistent redness and swelling, ulceration or erosion, and bruising, with no rates given.
Neither list is XERF's.
Thermage's listed effects
- Mild-to-moderate pain during treatment
- Redness, usually resolving within 24 hours
- Swelling, usually resolving within 5 days, can last several weeks
- Infrequently: burns with blistering or scabbing, possible scarring, numbness or tingling, lumps under the skin, skin darkening
Sofwave's listed effects
- Significant pain and tenderness
- Changes in skin pigmentation
- Persistent redness and swelling
- Ulceration or erosion, and bruising
- No rates given
Marketing words are not data.
Every adverse-event list in this section comes from a device maker's own labeling, none of it is a prediction for XERF, and none of it should be averaged into one.
Thermage's maker lists infrequent burns with blistering or scabbing and possible scarring among its adverse events. We could not verify any adverse-event data for XERF itself — ask the provider what its labeling reports. Blistering, spreading swelling or skin color changes after an energy treatment are reasons to contact the treating provider.
XERF vs alternatives: which is right for you?
Among the energy devices cleared for facial rejuvenation, this guide compares Thermage FLX, Ultherapy and Sofwave.
Each holds 510(k) clearances that name cosmetic indications — the thing XERF's record does not have.
| Device | Energy, per FDA records | FDA-cleared indications |
|---|---|---|
| XERF (Cynosure Lutronic) | Monopolar RF at 2 MHz and 6.78 MHz | Electrocoagulation and hemostasis in dermatologic and general surgical procedures — no cosmetic indication named |
| Thermage FLX (Solta Medical) | Monopolar RF at 6.78 MHz | Wrinkles and rhytids, including periorbital wrinkles on the upper and lower eyelids, plus electrocoagulation/hemostasis; with the vibration feature, temporary improvement in the appearance of cellulite |
| Ultherapy (Merz) | Micro-focused ultrasound with real-time imaging up to 8 mm deep | Lifting the eyebrow and lax submental (under-chin) and neck tissue; improving lines and wrinkles of the décolleté; improving skin laxity on the abdomen, front and back of the arms, and knees |
| Sofwave (Sofwave Medical) | Parallel-beam ultrasound at 10–12 MHz, focused in the dermis | Improving facial lines and wrinkles; lifting the eyebrow and lax submental and neck tissue in people 22 and older; short-term improvement in the appearance of cellulite, acne scars and upper-arm skin laxity |
Read the middle column against the right one and the differences are clear.
Ultherapy and Sofwave are the two with "lift" in their clearances — eyebrow and lax submental and neck tissue — while Thermage FLX's clearance says wrinkles and rhytids, not lifting; Solta's "skin tightening" phrasing is marketing, and its cleared text says wrinkles.
XERF is the only device in this table whose cleared indication names no cosmetic use at all, so any cosmetic treatment a clinic performs with it sits outside its 510(k).
What the record can't settle is which device works best.
We found no head-to-head trial comparing Thermage with Ultherapy, or Sofwave with Ultherapy, in our research pass, so comparisons rest on each device's own clearance and its maker's statements — and no gallery of before-and-afters predicts what your skin will do.
Which device suits your skin is a licensed provider's call, made in person.
Our overview of skin tightening options compares the full field — RF, ultrasound and laser — and what each is cleared for.
How do you choose a XERF provider near you?
Start with the legal frame.
There is no single federal legal definition of a med spa: whether one is regulated as a medical practice, and who may own it, is determined by each state's medical-practice, nursing and corporate-practice rules.
AmSpa — the American Med Spa Association — describes med spas as medical practices where "many of the services they render are considered the practice of medicine", treats even botulinum toxin injection as the practice of medicine because it uses a prescription drug, and stresses that the rules on who may treat, and under what supervision, vary by state.
So put three questions to each clinic: who will operate the device, what license that person holds, and who supervises the practice.
For the full vetting process — credentials, consultation, red flags — our how to choose a med spa checklist walks through it step by step.
For XERF specifically, add these questions:
- Which device exactly will be used, and which handpiece tips?
- What is it FDA-cleared for, and which of my treatment's uses are outside that clearance?
- Who operates the device, and what training and license do they hold?
- How many sessions does your protocol assume, and what results do you document?
- What adverse events does the device labeling list, and how often does your team see them?
- What is the total cost — per session or package — and what is included?
One more check is XERF-specific: before-and-after photos.
Under the FTC's endorsement guides, a result shown in an ad is read as representative of what consumers generally achieve, and the FTC says disclaimers like "results not typical" are generally insufficient on their own.
When a clinic shows you photos, ask how many treatments the person had, how long after treatment the photo was taken, and whether the images are unretouched.
Prices, packages and the devices actually on site vary clinic by clinic and city by city.
The questions above, asked at more than one consult, are the research that matters.
Frequently asked questions
Is XERF FDA-cleared for skin tightening?
No. FDA cleared XERF on 11 Aug 2025 (K251327) for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
The clearance text does not mention skin tightening, wrinkles or lifting, so skin tightening is not a cleared use of the device.
If a clinic describes XERF as cleared for tightening, ask which indication it is treating under and what published evidence supports the cosmetic use.
Who makes the XERF device?
XERF is made by Lutronic, now Cynosure Lutronic.
FDA's 510(k) records list the device as an electrosurgical unit cleared on 11 Aug 2025 (K251327), with Solta's Thermage FLX — a monopolar RF device cleared for wrinkles — as its predicate device.
The predicate is the marketed device FDA used as the comparison in its review.
How much does XERF cost?
We could not confirm any published price for XERF and found no national average: ASPS's 2025 statistics release reports no fees for minimally invasive procedures.
For this device family, the number of sessions is a main price driver, and makers' session norms vary; single-use consumables add per-treatment cost too — Solta says Thermage's tips deliver a set number of pulses and then can't be reused.
Get quotes from more than one clinic, per session and as a package.
How many XERF sessions will I need?
No verified session count for XERF appears in our research.
For scale, the makers of comparable devices say: Thermage is typically a single session, Sofwave one 30–45-minute session, Halo 1–2 treatments, Fraxel up to 5, Clear + Brilliant 4–6 for visible results, Moxi 2–4, and Merz calls Ultherapy PRIME a single-session treatment.
Those are each maker's claims for its own device, not XERF data.
Ask your clinic what its protocol assumes.
What is the difference between XERF and Thermage?
They are both monopolar RF devices, and Thermage FLX was the predicate in XERF's 510(k) review — the marketed device FDA used as its comparison — but FDA's summary says XERF delivers two frequencies (2 MHz and 6.78 MHz) where Thermage FLX delivers 6.78 MHz only.
Their clearances differ more: Thermage FLX is cleared for wrinkles and rhytids including the eyelids, while XERF's only cleared indication is electrocoagulation and hemostasis, with no cosmetic indication named.
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
- Safety Information · sofwave.com
- accessdata.fda.gov · U.S. Food and Drug Administration
- 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
- 16 CFR 255.2 -- Consumer endorsements. · ecfr.gov
- What Are the Rules for Who Can Inject Neurotoxins? · American Med Spa Association
- What Is Required of a Medical Spa's Good Faith Exams? · 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.