Thermage is a brand of radiofrequency (RF) treatment that heats the skin with electrical energy to treat wrinkles and loose skin. The FDA's 2017 clearance record names the Thermage FLX System, made by Solta Medical.1
Here is what that record lists, what two systematic reviews of radiofrequency devices found, and what to ask. It gives no settings. Whether to have it is for you and a clinician.
What the FDA record lists
In the FDA's 2017 clearance, the radiofrequency-only parts of the Thermage FLX System are cleared for dermatologic and general surgical procedures for electrocoagulation and hemostasis, for non-invasive treatment of periorbital wrinkles, including the upper and lower eyelids, and for non-invasive treatment of wrinkles.1
When radiofrequency energy and skin vibration are applied together, the record adds the temporary improvement in the appearance of cellulite, relief of minor muscle aches and pains and of muscle spasms, and temporary improvement of local circulation.1 The device is for prescription use.1
Thermage FLX uses in the FDA's 2017 record
- Non-invasive treatment of wrinkles, including around the eyes and eyelids
- Electrocoagulation and hemostasis in dermatologic and general surgical procedures
- With skin vibration: temporary improvement in the appearance of cellulite
- With skin vibration: relief of minor muscle aches, pains and spasms
- With skin vibration: temporary improvement of local circulation
It is a clearance, which isn't the same as an approval: the FDA found the device substantially equivalent to an earlier Thermage system.1 The record doesn't mention tightening or lifting by name.
Myth
Thermage is FDA-approved to tighten and lift skin.
Fact
The FDA's 2017 clearance of Thermage FLX lists wrinkles, including around the eyes, and, with vibration, the appearance of cellulite. It is a clearance, not an approval, and the wording doesn't use the words tightening or lifting.
What the reviews found
A 2022 systematic review of 23 articles looked at monopolar and bipolar radiofrequency devices for the face and body. It found clinical evidence of measurable improvement in skin laxity with an acceptable complication profile. Most complications were minor and transient, and the major complication rate was higher with monopolar devices than with bipolar ones.2
A larger 2022 review of 121 articles on radiofrequency for the face and neck found it improved acne scars, skin laxity, elasticity and overall skin look. Patient satisfaction was higher among people who wanted modest rejuvenation. One patient developed a neck fistula.3
What med spas name
236 of the 7,475 med spas we list name Thermage. That doesn't show who runs it or what for, so ask.4 For a different kind of radiofrequency treatment, see our Morpheus8 page. Which licensed professionals may operate a device depends on your state. See our guide to who may inject.
Here is what to bring to a consultation.
Questions to bring
The device and the person
Results and risks
Cost
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Find clinics
Each listing shows what the clinic’s own website offers, its Google reviews and its hours. No clinic is graded yet.
Common questions
What is Thermage cleared for?
The FDA's 2017 clearance of Thermage FLX lists non-invasive treatment of wrinkles, including around the eyes, and electrocoagulation and hemostasis. With skin vibration it also lists the temporary appearance of cellulite and relief of minor muscle aches.
Is Thermage FDA-approved?
It is FDA-cleared, which isn't the same as approved. The FDA found Thermage FLX substantially equivalent to an earlier Thermage system.
Does Thermage work?
Two 2022 reviews of radiofrequency devices found measurable improvement in skin laxity with mostly minor, transient complications. They cover the class of devices, not Thermage alone.
What are the risks of radiofrequency tightening?
The reviews describe mostly minor, transient complications, with major complications reported more often with monopolar devices than bipolar ones.
Sources (4)
- FDA 510(k) summary K170758, Thermage FLX System (cleared 2017-09-22) · US Food and Drug Administration, 510(k) database. Read in full on 30 Oct 2026. The database lists 16 Thermage entries from 2000 to 2008 plus later Solta Medical entries (K132431, K170758, K173759); only K170758 was read. · read 30 Oct 2026
- Minimally Invasive Approach to Skin Tightening of the Face and Body: Systematic Review of Monopolar and Bipolar Radiofrequency Devices (Plast Reconstr Surg 2022, PubMed 35877937) · Peer-reviewed systematic review of 23 articles. Abstract read on 30 Oct 2026; full text not read. · read 30 Oct 2026
- Evaluating the effectiveness and safety of radiofrequency for face and neck rejuvenation: A systematic review (Lasers Surg Med 2022, PubMed 34923652) · Peer-reviewed systematic review of 121 articles. Abstract read on 30 Oct 2026; full text not read. · read 30 Oct 2026
- Clinic websites: what they say on their own pages · Our own read of listed clinics' websites in the 14 states we cover, October 2026. A clinic counts once. · read 30 Oct 2026