Solta Medical
Thermage FLX
A noninvasive monopolar radiofrequency platform that heats tissue while cooling the skin surface.
Monopolar radiofrequency treatmentReviewed 7/30/2026Source recorded
At a glance
| Primary purpose | Noninvasive treatment of wrinkles and rhytids within the device's cleared indications; cosmetic 'lifting' language should be understood as modest tissue contraction/remodelling rather than surgery. |
|---|---|
| Mechanism | Delivers 6.78 MHz monopolar radiofrequency energy to produce controlled tissue heating and selective coagulation while contact cooling protects the epidermis. |
| When results appear | Manufacturer materials describe gradual change over roughly 2 to 6 months. |
| Typical sessions | Commonly marketed as one treatment; repeat treatment is individualized and not guaranteed by clearance. |
| Downtime | Usually no planned downtime, but transient redness, swelling, soreness, or contour symptoms can occur. |
| Longevity | Manufacturer materials describe results lasting about 1 to 2 years; independent evidence is heterogeneous and individual response varies. |
| Reversibility | Not reversible; delivered thermal injury cannot be withdrawn. |
| Documented risks | Pain, erythema, swelling, burns, blisters, scarring, pigment change, altered sensation, nodules, and contour irregularity; electrical implants are an important contraindication in device instructions. |
| Most common disappointment | Improvement can be subtle or absent and should not be compared with surgical lifting. |
| Common marketing misconception | FDA clearance for device indications is not proof of a facelift-equivalent result. |
| What varies by provider | Tip, pulse count, energy, treatment vectors, tissue contact, cooling, anatomy, and recognition of excessive heating. |
| Skin-tone considerations | Radiofrequency is not chromophore-targeted, but burns and post-inflammatory pigment change remain possible; settings and operator experience matter. |
| When this treatment may not be appropriate | Not for someone expecting surgical correction; device instructions flag implanted electrical devices and require assessment of skin and medical contraindications. |
| United States regulatory status | Thermage FLX received FDA 510(k) clearance K170758 for device-specific noninvasive indications including treatment of wrinkles and rhytids; clearance is not an approval of every marketing claim. |
| Canadian regulatory status | Health Canada MDALL lists Thermage FLX under active Class III licence 112966; older Thermage CPT records also exist. |
| Evidence status | High for device identity and regulatory mechanism; moderate and heterogeneous for magnitude and durability of cosmetic tightening. |
Sources
- FDA 510(k) database K170758FDA 510(k) record · regulatory-primary
- FDA 510(k) Summary K170758: Thermage FLXFDA 510(k) summary · regulatory-primary · supports 15 profile fields
- Health Canada MDALL: Solta Thermage licencesHealth Canada MDALL · regulatory-primary
- Systematic review of monopolar radiofrequency for facial rejuvenationpeer-reviewed systematic review · peer-reviewed-secondary
- Thermage 510(k) clearance summaryregulator
- Thermage CPT Technical User's Manualofficial manufacturer user manual · manufacturer-primary · supports 8 profile fields
- Thermage official patient informationofficial manufacturer information · manufacturer-primary
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