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
- FDA status
Record scope: 510(k): K170758 names the Thermage/ThermaCool family. Checked 4 Sep 2026.
- Supplies & recurring costs
- Single-use, shot-limited Total Tip — one patient per tip. The September 4, 2026 catalog review did not verify a US manufacturer Total Tip list price.
Used-market price reference
- Used asking price
- $40k–$80kReported source: Used listing · Aug 12, 2026
Used asking prices are research references, not completed-sale values or available inventory.
Sources and data on file
Data on file
- Recurring consumables
- Not verified
- FDA
- FDA record cited — see scopeK170758
- 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.
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: October 7, 2026 · How we verify
Compare new and used price references
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 record cited — see scope |
| 510(k) citation | K170758 |
| New price range | $100k–$145k |
| Used price reference | $40k–$80k |
| Consumables | Single-use, shot-limited Total Tip — one patient per tip. The September 4, 2026 catalog review did not verify a US manufacturer Total Tip list price. |
| Launch year | 2017 |
| Latest price source dated | Aug 12, 2026 |
| Manufacturer-source documents checked | Not published |
Overview
Thermage FLX is a monopolar radiofrequency platform with interchangeable treatment tips. The manufacturer describes AccuREP energy calibration, surface cooling and vibration during treatment.
Different tip sizes are offered for different treatment areas, so a system purchase should identify the tips and accessories actually included. A listing for the console alone does not establish the cost of patient treatments.
Confirm compatible tip supply, ownership registration and Solta service eligibility, particularly when comparing new and previously owned equipment.
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 K170758 Citation link repaired October 7, 2026: K170758 identifies Thermage FLX System and Accessories. The link documents that record; it does not establish every configuration, all marketed uses or current commercial availability. Other listed records and whole-profile verification dates are unchanged.510(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 affected models, lots or serial numbers and the required action.
Manufacturer response: none on file — manufacturers can reply via their company profile.
FDA record
Treatment & running costs
Treatment planning & budget
Treatment pricing source
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. The September 4, 2026 catalog review did not verify a US manufacturer Total Tip list price; 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. The September 4, 2026 catalog review did not verify a US manufacturer Total Tip list price.
Not yet documented: session schedule, treatment pricing, annual service costs.
Payback calculatorEnter your quote, volume and running costs
Estimate your payback
Enter your quote and treatment costs for Solta Medical Thermage FLX. Published figures appear where available; review them before using the estimate.
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.
Required — include staff time and your own time. Enter 0 only to explicitly exclude labor from this estimate.
Annual service contract ÷ 12, if you carry one.
Your estimate
Enter price you charge per treatment, consumable cost per treatment, labor 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.
Screening considerationsCatalog notes to check against the current instructions for use
Catalog screening notes
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.
These notes are not a complete or verified manufacturer contraindication list. Use the current instructions for the exact device and applicator to determine contraindications, warnings and patient eligibility.
Warranty & serviceWhat to confirm in writing before you buy
Published warranty details
Solta states that it has no authorized third-party resellers in the US and is not obligated to service or support equipment obtained from an unauthorized reseller. Confirm the written warranty, ownership transfer and service eligibility for the specific unit before purchase.
Source notes
Solta US reseller/service policy documented in manufacturer footer. Duration, exclusions and extended-service cost remain quote-specific.
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
Owner & operator reviews
Write a reviewNo owner or operator reviews yet. Be the first →
Current alternatives
Current catalog models to research. Confirm availability and configuration with the supplier.
Classys EVERESSE (Volnewmer)
Monopolar RF skin tightening
New-equipment price not yet documented.
Research comparisons
Includes current and older models.
History8 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
October 7, 2026
Catalog evidence limits 2026-10-07
Editorial evidence-limit correction: distinguish information not verified in this catalog from a claim that it is unavailable anywhere. Remove unsupported market rankings, blanket safety, comparative costs or return assumptions where present. Equipment price fields, source observation dates and whole-profile verification dates are unchanged. This is not new complete-profile or commercial-price verification.
Source: https://aestheticindex.co/methodology
October 7, 2026
Citation link repair 2026-10-07
Repaired citation URL after direct source inspection; no catalog status, indication, equipment price or whole-profile date changed.
Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K170758
October 6, 2026
Warranty & service
Source: Catalog update
October 6, 2026
Platform documentation and model scope
Reviewed changed fields only on October 6, 2026. Unchanged equipment prices and other fields are not reverified. Source regions and model generations must not be generalized.
Source: https://www.thermage.com/hcp
October 6, 2026
warranty service platform evidence
Claim-specific evidence; not a whole-profile verification.
Source: https://www.thermage.com/hcp
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 November 2, 2026).
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