Cynosure MonaLisa Touch
Fractional CO2 (gynecologic) · DEKA SmartXide fractional CO2 with intravaginal probe
Technology: CO2 Fractional Laser
Classification & configurations
Category group: Resurfacing & pigment (ablative, fractional, picosecond, vascular)
At a glance
- New price
- $100k–$140kSource not documented
- Used asking price
- $20k–$50kSource not documented
- FDA status
- Supplies & recurring costs
- See supply and replacement costs below.
Sources and verified data on file
Data on file
- Recurring consumables
- Not verified
- FDA
- FDA ClearedK133895
- Used asking prices
- Not verified
- 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.
Read FDA-cleared indicationsExact wording from 1 FDA record
K133895 (El.En S.P.A., 2014)
It is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: September 7, 2026 · How we verify
Axis runs $0–$140k. 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 | 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 | Fractional CO2 (gynecologic) |
| Technology | DEKA SmartXide fractional CO2 with intravaginal probe |
| FDA status | FDA Cleared |
| 510(k) citation | K133895 |
| New price range | $100k–$140k |
| Used asking range | $20k–$50k |
| Consumables | Not published |
| Launch year | 2015 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
How it worksTechnology and manufacturing
How the technology works
10,600nm fractional CO2 delivered through a rotating intravaginal handpiece placing microablative columns in vaginal mucosa; intended biology is epithelial thickening, neocollagenesis, and improved vascularity in atrophic tissue.
Used (off-label) for symptoms associated with genitourinary syndrome of menopause — dryness, dyspareunia, laxity sensation — and external vulvar applications; standard course is three brief in-office sessions ~6 weeks apart with an annual touch-up.
Uncontrolled series report symptom improvement; sham-controlled trials have not reproduced that difference, and FDA issued a safety communication in July 2018 about claims for energy-based devices in vaginal procedures.
Patented technology
DEKA's pulse-shaping (DEKA Pulse / SmartStak stacking) on the SmartXide platform plus the purpose-built 360-degree vaginal scanner probe; the probe geometry, not the CO2 source, is the differentiator.
Origin
DEKA M.E.L.A. (El.En.
Group), Florence, Italy; Cynosure holds North American distribution.
FDA & regulatory detailClearance timeline, authorization route and citation notes
Launch 2015 · Clearance 2018 · K133895
Platform clearance: K133895 (DEKA SMARTXIDE, El.En., decision 5 Sep 2014). Checked 4 Sep 2026.
FDA-cleared indications (verbatim)
K133895 (El.En S.P.A., 2014)
It is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
CO2 fractional — DEKA SmartXide fractional CO2 with intravaginal probe
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Parent company: Cynosure Lutronic
Legal manufacturer: Cynosure LLC (United States)
Applicant on the FDA record
El.En. S.p.A.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.
Treatment & running costs
Treatments
Sessions & timing
No treatment schedule documented yet.
What practices charge
No sourced treatment price on file.
Supplies & recurring costs
Low per-case — single-use probe covers/hygiene barriers and smoke-evac supplies (tens of dollars); the meaningful lifecycle cost is eventual CO2 tube/optics service.
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 Cynosure MonaLisa Touch 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
Active genitourinary infection, undiagnosed bleeding, pregnancy, recent pelvic radiation or active malignancy workup, mesh complications in the field, severe prolapse needing surgical referral.
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.
No confirmed chain deployments recorded yet.
Owner & operator reviews
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Current alternatives
Current catalog models to research. Confirm availability and configuration with the supplier.
History7 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
September 7, 2026
science
Catalog update — editorial sentences removed (neutral-voice standard, 7 Sep 2026)
Source: Editorial standard
September 4, 2026
FDA status
Unknown → Cleared
Source: Catalog update
September 4, 2026
510(k) numbers
K-number set re-verified against openFDA
Source: Council round 2 audit, verified on openFDA 2026-09-04
September 4, 2026
FDA K-numbers
Source: Catalog update
September 4, 2026
FDA source URL
Source: Catalog update
September 4, 2026
FDA status
Unknown → Cleared
Clearance located on openFDA
Source: Council round 2 audit, verified on openFDA 2026-09-04
August 1, 2026
Record created
Added to The Aesthetic Index — August 2026
Source: The Aesthetic Index editorial
Cite this data: The Aesthetic Index, "Cynosure MonaLisa Touch — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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