Cynosure FlexSure
RF body contouring · Wrap-around hands-free RF applicators
At a glance
- New price
- $40k–$70kSource not documented
- FDA status
- Supplies & recurring costs
- Supply details not yet documented.
Sources and verified data on file
Data on file
- Recurring consumables
- Not verified
- FDA
- FDA ClearedK200241
- Used asking prices
- Not verified
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- Bottle prices and estimates may still appear under Treatment & running costs.
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Figures are reference points, not current offers.
Read FDA-cleared indicationsExact wording from 1 FDA record
K200241 (Cynosure, LLC, 2020)
The TempSure™ System has the following indications for use: The 10mm, 15mm, and 20mm Smart Handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids. The 18mm, 25mm, 30mm, 60mm Smart Handpieces and FlexSure™ applicators provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite. The following surgical modes are applicable to the generator: Coagulation/Hemostasis: General surgical procedures including urologic, thoracic, plastic, reconstructive, and gynecological procedures where electrosurgical coagulation of tissue is performed. Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags and blepharoplasty. Blended Cutting and Coagulation: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, and development of skin flaps. Fulguration: basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, hemostasis. Bipolar: pinpoint precise coagulation, pinpoint hemostasis in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: August 6, 2026 · How we verify
Axis runs $0–$70k. Reference figures, not current offers.
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 | Cynosure |
|---|---|
| Company | Owner: Hahn & Company (South Korean private equity) (private equity owned, since 2024) · Distribution: direct |
| Parent company | Cynosure Lutronic |
| Brand owner | Cynosure |
| Built by (OEM) | Cynosure LLC |
| Category | Body Contouring |
| Technology | Wrap-around hands-free RF applicators |
| FDA status | FDA Cleared |
| 510(k) citation | K200241 |
| New price range | $40k–$70k |
| Used asking range | Not published |
| Consumables | Not published |
| Launch year | 2021 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
Conformable RF wraps for body areas
FDA & regulatory detailClearance timeline, authorization route and citation notes
FDA-cleared indications (verbatim)
K200241 (Cynosure, LLC, 2020)
The TempSure™ System has the following indications for use: The 10mm, 15mm, and 20mm Smart Handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids. The 18mm, 25mm, 30mm, 60mm Smart Handpieces and FlexSure™ applicators provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite. The following surgical modes are applicable to the generator: Coagulation/Hemostasis: General surgical procedures including urologic, thoracic, plastic, reconstructive, and gynecological procedures where electrosurgical coagulation of tissue is performed. Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags and blepharoplasty. Blended Cutting and Coagulation: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, and development of skin flaps. Fulguration: basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, hemostasis. Bipolar: pinpoint precise coagulation, pinpoint hemostasis in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
RF body contouring — Wrap-around hands-free RF applicators
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
510(k) numbers
Parent company: Cynosure Lutronic
Legal manufacturer: Cynosure LLC (United States)
Applicant on the FDA record
Cynosure, LLCThe 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.
Treatment & running costs
Treatments
Sessions & timing
No treatment schedule documented yet.
What practices charge
No sourced treatment price on file.
Supplies & recurring costs
Consumable costs are not documented yet.
Annual service & support
No annual service cost documented yet.
Payback calculatorModel your own volume, labor and service costs
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Pre-filled from our published Cynosure FlexSure 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.
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History1 tracked change
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
August 1, 2026
Record created
Added to The Aesthetic Index — August 2026
Source: The Aesthetic Index editorial
Cite this data: The Aesthetic Index, "Cynosure FlexSure — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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