Thermage FLX
Solta Medical
face, periorbital area, neck, body
Thermage FLX vs. Ultherapy
Last verified 7/30/2026
Ultherapy
Merz Aesthetics / Ulthera, Inc.
brow, submental area, neck, décolletage
Quick comparison
| Attribute | Thermage FLX | Ultherapy |
|---|---|---|
| Manufacturer | Solta Medical | Merz Aesthetics / Ulthera, Inc. |
| Energy type | Monopolar radiofrequency treatment | Microfocused ultrasound with visualization |
| Intended areas | face, periorbital area, neck, body | brow, submental area, neck, décolletage |
| Delivery approach | Delivers 6.78 MHz monopolar radiofrequency energy to produce controlled tissue heating and selective coagulation while contact cooling protects the epidermis. | Real-time ultrasound imaging guides microfocused ultrasound energy to create discrete thermal-coagulation points at selected tissue depths, initiating a wound-healing and collagen-remodelling response. |
| Typical course | Commonly marketed as one treatment; repeat treatment is individualized and not guaranteed by clearance. | Often one treatment in manufacturer protocols; additional treatment depends on response and clinical plan. |
| Results timing | Manufacturer materials describe gradual change over roughly 2 to 6 months. | Manufacturer and clinical literature describe change developing over about 2 to 3 months and continuing up to 6 months. |
| Downtime | Usually no planned downtime, but transient redness, swelling, soreness, or contour symptoms can occur. | Usually no planned downtime; transient erythema, edema, tenderness, bruising, welts, or altered sensation can occur. |
| Longevity | Manufacturer materials describe results lasting about 1 to 2 years; independent evidence is heterogeneous and individual response varies. | Published reviews report improvement assessed out to roughly one year, while manufacturer materials say a year or longer; durability varies. |
| Pricing basis | Usually per session, treatment area, and pulse/tip plan; face, eyes, neck, and body prices are not interchangeable. | Usually per treatment area and number of lines; full-face, lower-face/neck, brow, and chest quotes should remain separate. |
| 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. | FDA 510(k)-cleared through device-specific submissions including K121700 for brow, submental, and neck lifting and K134032 for décolletage lines. |
| Major limitations | Improvement can be subtle or absent and should not be compared with surgical lifting. | The measured lift is generally modest and may not be visible enough for someone seeking surgical-level change. |
Manufacturer
- Thermage FLX
- Solta Medical
- Ultherapy
- Merz Aesthetics / Ulthera, Inc.
Energy type
- Thermage FLX
- Monopolar radiofrequency treatment
- Ultherapy
- Microfocused ultrasound with visualization
Intended areas
- Thermage FLX
- face, periorbital area, neck, body
- Ultherapy
- brow, submental area, neck, décolletage
Delivery approach
- Thermage FLX
- Delivers 6.78 MHz monopolar radiofrequency energy to produce controlled tissue heating and selective coagulation while contact cooling protects the epidermis.
- Ultherapy
- Real-time ultrasound imaging guides microfocused ultrasound energy to create discrete thermal-coagulation points at selected tissue depths, initiating a wound-healing and collagen-remodelling response.
Typical course
- Thermage FLX
- Commonly marketed as one treatment; repeat treatment is individualized and not guaranteed by clearance.
- Ultherapy
- Often one treatment in manufacturer protocols; additional treatment depends on response and clinical plan.
Results timing
- Thermage FLX
- Manufacturer materials describe gradual change over roughly 2 to 6 months.
- Ultherapy
- Manufacturer and clinical literature describe change developing over about 2 to 3 months and continuing up to 6 months.
Downtime
- Thermage FLX
- Usually no planned downtime, but transient redness, swelling, soreness, or contour symptoms can occur.
- Ultherapy
- Usually no planned downtime; transient erythema, edema, tenderness, bruising, welts, or altered sensation can occur.
Longevity
- Thermage FLX
- Manufacturer materials describe results lasting about 1 to 2 years; independent evidence is heterogeneous and individual response varies.
- Ultherapy
- Published reviews report improvement assessed out to roughly one year, while manufacturer materials say a year or longer; durability varies.
Pricing basis
- Thermage FLX
- Usually per session, treatment area, and pulse/tip plan; face, eyes, neck, and body prices are not interchangeable.
- Ultherapy
- Usually per treatment area and number of lines; full-face, lower-face/neck, brow, and chest quotes should remain separate.
Regulatory status
- Thermage FLX
- 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.
- Ultherapy
- FDA 510(k)-cleared through device-specific submissions including K121700 for brow, submental, and neck lifting and K134032 for décolletage lines.
Major limitations
- Thermage FLX
- Improvement can be subtle or absent and should not be compared with surgical lifting.
- Ultherapy
- The measured lift is generally modest and may not be visible enough for someone seeking surgical-level change.
Benefits and trade-offs
Thermage FLX
- May produce gradual, modest smoothing or tightening through thermal tissue contraction and remodelling.
- It does not add filler volume, paralyze muscles, remove large skin excess, or reproduce a surgical facelift.
- Improvement can be subtle or absent and should not be compared with surgical lifting.
Ultherapy
- May produce modest, gradual lifting or tightening in selected areas.
- It does not add volume, remove skin, relax muscles, or equal a surgical facelift.
- The measured lift is generally modest and may not be visible enough for someone seeking surgical-level change.
Details
Open a section for more context. Sources appear beside the claims they support.
Energy and depth
| Attribute | Thermage FLX | Ultherapy |
|---|---|---|
| How it works | Delivers 6.78 MHz monopolar radiofrequency energy to produce controlled tissue heating and selective coagulation while contact cooling protects the epidermis.
| Real-time ultrasound imaging guides microfocused ultrasound energy to create discrete thermal-coagulation points at selected tissue depths, initiating a wound-healing and collagen-remodelling response.
|
| Tightening effect | Modest and variable; noninvasive.
| Modest and variable; noninvasive.
|
| What it primarily changes | May produce gradual, modest smoothing or tightening through thermal tissue contraction and remodelling.
| May produce modest, gradual lifting or tightening in selected areas.
|
| What it does not change | It does not add filler volume, paralyze muscles, remove large skin excess, or reproduce a surgical facelift.
| It does not add volume, remove skin, relax muscles, or equal a surgical facelift.
|
How it works
- Thermage FLX
- Delivers 6.78 MHz monopolar radiofrequency energy to produce controlled tissue heating and selective coagulation while contact cooling protects the epidermis.
- FDA 510(k) Summary K170758: Thermage FLX · accessdata.fda.gov
- Ultherapy
- Real-time ultrasound imaging guides microfocused ultrasound energy to create discrete thermal-coagulation points at selected tissue depths, initiating a wound-healing and collagen-remodelling response.
- Ultherapy Instructions for Use · ultherapy.com
Tightening effect
- Thermage FLX
- Modest and variable; noninvasive.
- FDA 510(k) Summary K170758: Thermage FLX · accessdata.fda.gov
- Ultherapy
- Modest and variable; noninvasive.
- FDA 510(k) Summary K121700: Ulthera System · accessdata.fda.gov
What it primarily changes
- Thermage FLX
- May produce gradual, modest smoothing or tightening through thermal tissue contraction and remodelling.
- FDA 510(k) Summary K170758: Thermage FLX · accessdata.fda.gov
- Ultherapy
- May produce modest, gradual lifting or tightening in selected areas.
- FDA 510(k) Summary K121700: Ulthera System · accessdata.fda.gov
What it does not change
- Thermage FLX
- It does not add filler volume, paralyze muscles, remove large skin excess, or reproduce a surgical facelift.
- FDA 510(k) Summary K170758: Thermage FLX · accessdata.fda.gov
- Ultherapy
- It does not add volume, remove skin, relax muscles, or equal a surgical facelift.
- FDA 510(k) Summary K121700: Ulthera System · accessdata.fda.gov
Session and recovery
| Attribute | Thermage FLX | Ultherapy |
|---|---|---|
| Reported discomfort | Published systematic reviews describe moderate treatment discomfort on average, with substantial patient and protocol variation.
| |
| Downtime | Usually no planned downtime, but transient redness, swelling, soreness, or contour symptoms can occur.
| Usually no planned downtime; transient erythema, edema, tenderness, bruising, welts, or altered sensation can occur.
|
| Swelling | Temporary swelling is possible.
| Mild transient edema is reported.
|
Reported discomfort
- Thermage FLX
- Ultherapy
- Published systematic reviews describe moderate treatment discomfort on average, with substantial patient and protocol variation.
- Systematic review and meta-analysis of microfocused ultrasound · pubmed.ncbi.nlm.nih.gov
Downtime
- Thermage FLX
- Usually no planned downtime, but transient redness, swelling, soreness, or contour symptoms can occur.
- Thermage CPT Technical User's Manual · ca.thermage.com
- Ultherapy
- Usually no planned downtime; transient erythema, edema, tenderness, bruising, welts, or altered sensation can occur.
- Ultherapy Instructions for Use · ultherapy.com
Swelling
Risks and limitations
| Attribute | Thermage FLX | Ultherapy |
|---|---|---|
| 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.
| Pain, redness, swelling, bruising, welts, transient numbness or weakness, burns, scarring, and contour change; correct depth and anatomy are critical.
|
| Most likely disappointment | Improvement can be subtle or absent and should not be compared with surgical lifting.
| The measured lift is generally modest and may not be visible enough for someone seeking surgical-level change.
|
| 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.
| Not appropriate for surgical-level laxity expectations or where IFU contraindications, open wounds, severe acne, or implanted devices in the treatment path apply.
|
| Provider-dependent variables | Tip, pulse count, energy, treatment vectors, tissue contact, cooling, anatomy, and recognition of excessive heating.
| Imaging, line count, transducer depth, vector planning, energy, tissue coupling, anatomy, and pain management.
|
| Skin-tone considerations | Radiofrequency is not chromophore-targeted, but burns and post-inflammatory pigment change remain possible; settings and operator experience matter.
| Ultrasound is not melanin-targeted, but injury, burns, and post-inflammatory pigment change can still follow poor technique.
|
Documented risks
- Thermage FLX
- Pain, erythema, swelling, burns, blisters, scarring, pigment change, altered sensation, nodules, and contour irregularity; electrical implants are an important contraindication in device instructions.
- Thermage CPT Technical User's Manual · ca.thermage.com
- Ultherapy
- Pain, redness, swelling, bruising, welts, transient numbness or weakness, burns, scarring, and contour change; correct depth and anatomy are critical.
- Ultherapy Instructions for Use · ultherapy.com
Most likely disappointment
- Thermage FLX
- Improvement can be subtle or absent and should not be compared with surgical lifting.
- FDA 510(k) Summary K170758: Thermage FLX · accessdata.fda.gov
- Ultherapy
- The measured lift is generally modest and may not be visible enough for someone seeking surgical-level change.
- FDA 510(k) Summary K121700: Ulthera System · accessdata.fda.gov
When this treatment may not be appropriate
- Thermage FLX
- Not for someone expecting surgical correction; device instructions flag implanted electrical devices and require assessment of skin and medical contraindications.
- Thermage CPT Technical User's Manual · ca.thermage.com
- Ultherapy
- Not appropriate for surgical-level laxity expectations or where IFU contraindications, open wounds, severe acne, or implanted devices in the treatment path apply.
- Ultherapy Instructions for Use · ultherapy.com
Provider-dependent variables
- Thermage FLX
- Tip, pulse count, energy, treatment vectors, tissue contact, cooling, anatomy, and recognition of excessive heating.
- Thermage CPT Technical User's Manual · ca.thermage.com
- Ultherapy
- Imaging, line count, transducer depth, vector planning, energy, tissue coupling, anatomy, and pain management.
- Ultherapy Instructions for Use · ultherapy.com
Skin-tone considerations
- Thermage FLX
- Radiofrequency is not chromophore-targeted, but burns and post-inflammatory pigment change remain possible; settings and operator experience matter.
- Thermage CPT Technical User's Manual · ca.thermage.com
- Ultherapy
- Ultrasound is not melanin-targeted, but injury, burns, and post-inflammatory pigment change can still follow poor technique.
- Ultherapy Instructions for Use · ultherapy.com
Evidence and regulatory status
| Attribute | Thermage FLX | Ultherapy |
|---|---|---|
| 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.
| FDA 510(k)-cleared through device-specific submissions including K121700 for brow, submental, and neck lifting and K134032 for décolletage lines.
|
| Canadian regulatory status | Health Canada MDALL lists Thermage FLX under active Class III licence 112966; older Thermage CPT records also exist.
| Health Canada MDALL lists the Ulthera System under active Class III licence 79689.
|
| Evidence status | High for device identity and regulatory mechanism; moderate and heterogeneous for magnitude and durability of cosmetic tightening.
| High for device identity and cleared indications; moderate for modest efficacy and one-year durability, with heterogeneous protocols.
|
United States regulatory status
- Thermage FLX
- 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.
- Thermage 510(k) clearance summary · accessdata.fda.gov
- FDA 510(k) database K170758 · accessdata.fda.gov
- Ultherapy
- FDA 510(k)-cleared through device-specific submissions including K121700 for brow, submental, and neck lifting and K134032 for décolletage lines.
- Ultherapy 510(k) clearance summary · accessdata.fda.gov
- FDA 510(k) Summary K134032: Ulthera System · accessdata.fda.gov
Canadian regulatory status
- Thermage FLX
- Health Canada MDALL lists Thermage FLX under active Class III licence 112966; older Thermage CPT records also exist.
- Health Canada MDALL: Solta Thermage licences · health-products.canada.ca
- Ultherapy
- Health Canada MDALL lists the Ulthera System under active Class III licence 79689.
- Health Canada MDALL: Ulthera System · health-products.canada.ca
Evidence status
- Thermage FLX
- High for device identity and regulatory mechanism; moderate and heterogeneous for magnitude and durability of cosmetic tightening.
- Systematic review of monopolar radiofrequency for facial rejuvenation · pubmed.ncbi.nlm.nih.gov
- Ultherapy
- High for device identity and cleared indications; moderate for modest efficacy and one-year durability, with heterogeneous protocols.
- FDA 510(k) Summary K134032: Ulthera System · accessdata.fda.gov
SourcesShowHide
Sources are grouped by treatment so the support for each record stays visible.
Thermage FLX
- FDA 510(k) database K170758 · accessdata.fda.gov, 2017-09-29
- FDA 510(k) Summary K170758: Thermage FLX · accessdata.fda.gov, 2017-09-29 · supports 15 fields
- Health Canada MDALL: Solta Thermage licences · health-products.canada.ca
- Systematic review of monopolar radiofrequency for facial rejuvenation · pubmed.ncbi.nlm.nih.gov, 2022-07-21
- Thermage 510(k) clearance summary · accessdata.fda.gov
- Thermage CPT Technical User's Manual · ca.thermage.com, 2021-06-01 · supports 8 fields
- Thermage official patient information · thermage.com
Ultherapy
- FDA 510(k) Summary K121700: Ulthera System · accessdata.fda.gov, 2012-10-19 · supports 13 fields
- FDA 510(k) Summary K134032: Ulthera System · accessdata.fda.gov, 2014-07-18 · supports 2 fields
- Health Canada MDALL: Ulthera System · health-products.canada.ca
- Systematic review and meta-analysis of microfocused ultrasound · pubmed.ncbi.nlm.nih.gov, 2024-11-01
- Systematic review of microfocused ultrasound for facial rejuvenation · pubmed.ncbi.nlm.nih.gov, 2023-01-24
- Ultherapy 510(k) clearance summary · accessdata.fda.gov
- Ultherapy Instructions for Use · ultherapy.com, 2023-02-01 · supports 9 fields
- Ultherapy official patient information · ultherapy.com
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