Solta Medical Thermage FLX
Monopolar RF skin tightening · 4th-gen monopolar RF
Technology: Monopolar Radiofrequency
Classification & configurations
Category group: Skin tightening & remodeling (RF microneedling, monopolar RF, HIFU)
Also sold as / variants: Thermage NXT, Thermage CPT — applicator and configuration variants of the same platform, covered on this page.
At a glance
- New price
- $100k–$145kReported source: Dealer quote · Aug 12, 2026
- Used asking price
- $40k–$80kReported source: Used listing · Aug 12, 2026
- FDA status
- Supplies & recurring costs
- Single-use, shot-limited Total Tip — one patient per tip. Not published — Solta does not publish a US Total Tip list price (checked 4 Sep 2026).
Sources and verified data on file
Data on file
- Recurring consumables
- Not verified
- FDA
- FDA ClearedK170758
- Used asking prices
- 1 listing, latest Aug 12, 2026Used listing · Aug 12, 2026
- This panel shows a per-treatment supply cost only when a recorded figure has a dated source.
- Bottle prices and estimates may still appear under Treatment & running costs.
- The calculator may include a labeled planning estimate. Review it or enter your own allowance; missing data never means $0.
Figures are reference points, not current offers. Used asking prices are not completed-sale values.
Latest price source dated: Aug 12, 2026
·FDA database · Updated Aug 12, 2026Read FDA-cleared indicationsExact wording from 1 FDA record
K170758 (Solta Medical, 2017)
The radiofrequency-energy only delivery components of the Thermage FLX System are indicated for use in: • Dermatologic and general surgical procedures for electrocoagulation and hemostasis; • Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; • Non-invasive treatment of wrinkles and rhytids. The simultaneous application of radio frequency energy and skin vibration by the Thermage FLX System is indicated for use in: • Dermatologic and general surgical procedures for electrocoagulation and hemostasis; • Non-invasive treatment of periorbital wrinkles and rhytids; • Non-invasive treatment of wrinkles and rhytids; • Temporary improvement in the appearance of cellulite; • Relief of minor muscle aches and pains; • Relief of muscle spasms; • Temporary improvement of local circulation (i.e., blood circulation).
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: September 4, 2026 · How we verify
Axis runs $0–$145k. Reference figures, not current offers. Used asking prices are not completed-sale values.
Not verified
We hold no per-treatment consumable price for this device from a dated source. Ask the seller for a written per-treatment cost.
Price sourcesSources, dates and configurations
Key factsCompany, specifications and verification dates
| Manufacturer | Solta Medical |
|---|---|
| Company | Owner: Bausch Health Companies Inc. (NYSE/TSX: BHC) (subsidiary, since 2014) · Distribution: direct |
| Parent company | Solta Medical (Bausch Health) |
| Brand owner | Solta Medical |
| Built by (OEM) | Solta Medical Inc. |
| Category | Monopolar RF skin tightening |
| Technology | 4th-gen monopolar RF |
| FDA status | FDA Cleared |
| 510(k) citation | K170758 |
| New price range | $100k–$145k |
| Used asking range | $40k–$80k |
| Consumables | Single-use, shot-limited Total Tip — one patient per tip. Not published — Solta does not publish a US Total Tip list price (checked 4 Sep 2026). |
| Launch year | 2017 |
| Latest price source dated | Aug 12, 2026 |
| Manufacturer-source documents checked | Not published |
Overview
Current Thermage generation with body tip
How it worksTechnology and manufacturing
How the technology works
Monopolar capacitive RF delivers bulk volumetric heating of the dermis and subdermal fibrous septae (~1-4mm+ effective depth) to ~55-65C while cryogen spray protects the epidermis. Heat causes immediate collagen contraction plus remodeling over 3-6 months — tightening and texture smoothing rather than true lifting.
Cleared for face, eyelids (dedicated eye tip), and body areas. One session, retreatment every 1-2 years.
Patented technology
AccuREP per-pulse impedance tuning auto-calibrates energy at each placement; Total Tip 4.0 gives a larger (~4cm2) treatment area; Comfort Pulse Technology interleaves vibration and cooling to manage the heat sensation — historically the treatment's weak point.
Origin
Developed/manufactured historically in Hayward, California; now Solta Medical under Bausch Health — current site varies, verify.
FDA & regulatory detailClearance timeline, authorization route and citation notes
Source and verification notes
·FDA database · Updated Aug 12, 2026Clearance K170758510(k): K170758 names the Thermage/ThermaCool family. Checked 4 Sep 2026.
FDA-cleared indications (verbatim)
K170758 (Solta Medical, 2017)
The radiofrequency-energy only delivery components of the Thermage FLX System are indicated for use in: • Dermatologic and general surgical procedures for electrocoagulation and hemostasis; • Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; • Non-invasive treatment of wrinkles and rhytids. The simultaneous application of radio frequency energy and skin vibration by the Thermage FLX System is indicated for use in: • Dermatologic and general surgical procedures for electrocoagulation and hemostasis; • Non-invasive treatment of periorbital wrinkles and rhytids; • Non-invasive treatment of wrinkles and rhytids; • Temporary improvement in the appearance of cellulite; • Relief of minor muscle aches and pains; • Relief of muscle spasms; • Temporary improvement of local circulation (i.e., blood circulation).
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
Radiofrequency — monopolar — 4th-gen monopolar RF
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Parent company: Solta Medical (Bausch Health)
Legal manufacturer: Solta Medical Inc. (United States)
Applicant on the FDA record
Solta Medical, Inc.The applicant named on the FDA record can differ from the brand shown on the device.
Regulatory data comes from public FDA records and may lag recent updates. Confirm the applicable status and documentation before purchase.
FDA safety actions
Recorded recalls, warning letters and safety communications. Terminated actions remain visible as history.
How we report safety actionsChecked 7 Sep 2026 against FDA enforcement data dated 2 Sep 2026.
- RecallZ-1354-2023Class IIOngoing
Initiated Feb 16, 2023 · 1 unit
Scope as FDA lists it
Thermage CPT System / Thermage RF Generator, REF TG-2B (the earlier CPT generation, not the FLX generator). Affected unit: model TG-2B, UDI-DI 00850608002124, serial number 001933 — one service unit.
Reason and action
A service unit was potentially improperly tested and calibrated during manufacturing on a failed test station.
Recalling firm as FDA lists it: Solta Medical Inc. This record concerns a single Thermage CPT (TG-2B) service unit; it is listed on the Thermage FLX profile because the site has no separate CPT profile.
FDA event 91847. Added 8 Sep 2026.
Check the FDA record for the affected serial numbers — this notice does not mean every unit is affected.
Manufacturer response: none on file — manufacturers can reply via their company profile.
FDA record
Treatment & running costs
Treatments
Sessions & timing
No treatment schedule documented yet.
What practices charge
No sourced treatment price on file.
Supplies & recurring costs
One of the most consumable-heavy platforms in the market: the Total Tip is single-use and shot-limited, one patient per tip. Not published — Solta does not publish a US Total Tip list price (checked 4 Sep 2026); the figures previously shown mixed euro export pricing with undated reseller quotes.
- Vendor restrictions: hard-lock — electronic lockout enforces single use
Source notes
Dealer/distributor listings (Direct Dermal Fillers, Pinova) and Beautrek channel reporting, plus FDA listing of the tip as single-use; 30 Aug 2026 research pass. Currencies as published.
Additional supply notes
Single-use, shot-limited Total Tip — one patient per tip. Not published — Solta does not publish a US Total Tip list price (checked 4 Sep 2026).
Annual service & support
No annual service cost documented yet.
Payback calculatorModel your own volume, labor and service costs
Estimate your payback
Pre-filled from our published Solta Medical Thermage FLX data where we have it. Estimates appear once the required inputs are available. Review and adjust every pre-filled value before relying on the result.
Start from
No verified per-treatment supply cost is on file. Enter your own allowance. Use $0 only if you have confirmed that it applies to your practice.
Pre-filled from the midpoint of the published new-price range
20 is an illustrative default — change it to your volume.
No sourced per-session price on file — enter what you charge.
Required — enter your cost; missing data does not mean $0.
Provider or tech time for one treatment, fully loaded. Enter 0 if you own-operate.
Annual service contract ÷ 12, if you carry one.
Your estimate
Enter price you charge per treatment, consumable cost per treatment to see contribution and a payback range.
This model ignores financing — if you lease or borrow, add your monthly payment. Estimates from your inputs and our published ranges — not a projection, guarantee or financial advice. How we calculate this.
ComplianceScreening and contraindications on the manufacturer's record
Contraindications & screening
Pacemakers/defibrillators or other active electronic implants (monopolar RF with return pad), pregnancy, metal implants in the treatment area; screen for recent filler and impaired skin sensation.
Warranty & serviceWhat to confirm in writing before you buy
Before buying new or used, confirm in writing:
- Current warranty coverage
- Included training
- Service terms
Chains using this device
A chain listing does not establish availability at every location.
LaserAway
Aesthetic dermatology chain
Company technology + body contouring pages
Confirmed
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Current alternatives
Current catalog models to research. Confirm availability and configuration with the supplier.
Research comparisons
Includes current and older models.
History3 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
September 4, 2026
FDA source URL
Source: Catalog update
August 5, 2026
Warranty & service
Source: Catalog update
August 1, 2026
Record created
Added to The Aesthetic Index — August 2026
Source: The Aesthetic Index editorial
Cite this data: The Aesthetic Index, "Solta Medical Thermage FLX — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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