Cynosure MonaLisa Touch
Fractional CO2 (gynecologic) · DEKA SmartXide fractional CO2 with intravaginal probe
The Cynosure MonaLisa Touch typically sells new in the $100k–$140k range in the US, with used and refurbished systems around $20k–$50k. Cynosure MonaLisa Touch's FDA status is under verification by our research team. Figures are market estimates verified August 6, 2026.
Last verified: August 6, 2026 · How we verify
New: $100k–$140k|Used: $20k–$50kmarket estimate, no email required
| Manufacturer | Cynosure |
|---|---|
| Company | Owner: Hahn & Company (South Korean private equity) (private equity owned, since 2024) · Distribution: direct |
| Category | Resurfacing, Tattoo & Vascular |
| Technology | DEKA SmartXide fractional CO2 with intravaginal probe |
| FDA status | FDA status under verification |
| New price range | $100k–$140k |
| Used price range | $20k–$50k |
| Consumables | Not published |
| Launch year | 2015 |
| Last verified | August 6, 2026 |
Bottom line
The device that built — and then nearly sank — the "vaginal rejuvenation" category. A DEKA-built fractional CO2 with a 360-degree vaginal probe, distributed by Cynosure, and the market leader when FDA publicly cracked down in July 2018, sending "It Has Come to Our Attention" letters to seven manufacturers over marketing energy devices for rejuvenation, GSM, and sexual function without cleared indications. Add a 2021 JAMA sham-controlled trial finding no significant benefit over sham for menopausal vaginal symptoms, and this is a buy-with-eyes-open device: real patient demand and strong cash-pay economics inside OB/GYN and urogyn practices, but your marketing must live strictly inside the surgical clearance and your consent process must be honest about the evidence. Do not put this in a lash-and-Botox spa.
Overview
No editorial overview published for this platform yet.
How it works
The science
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; the sham-controlled data is far less flattering — exactly why FDA drew the line on claims.
Patented tech
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 status
FDA status under verification — see our FDA guide. We do not publish an indication or a clearance number for this profile until the record is confirmed against the FDA database.
Regulatory data is compiled from public FDA 510(k) records and may lag recent clearances. Always confirm status with the manufacturer before purchase.
Recent industry events
How we source company dataOwnership and corporate changes at Cynosure that can affect warranty, service and parts availability.
- Jan 2024
Cynosure and Lutronic merge under Hahn & Company
MergerCynosure and Lutronic announced their merger on January 19, 2024, closing later that year to form Cynosure Lutronic, Inc. under South Korean private equity firm Hahn & Company; terms undisclosed. This followed CD&R's 2019 purchase of Cynosure from Hologic for $205M and Hahn's 2023 acquisition of Lutronic.
Source: PR Newswire (Jan 19, 2024); Hologic filings
Treatment economics
What practices charge
Cash-pay only: $600-1,200 per session, 3-session course at $1,800-3,000, plus annual maintenance singles $500-900. Menopause-clinic and urogyn settings sustain the top of the range.
Consumables & recurring cost
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.
Ideal for
Best-fit practice
OB/GYN, urogynecology, and menopause-focused physician practices where the clinician already owns the pelvic-health conversation; patients largely 45-70, postmenopausal, plus breast-cancer survivors avoiding systemic estrogen (a population requiring especially careful consent). Medspas without gynecologic clinical depth should pass.
Compliance
Medical director & delegation
A surgical CO2 laser used intravaginally — physician-performed or tightly physician-supervised in virtually every state; delegation latitude for facial lasers does not translate here.
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.
Ownership
Warranty & service
~1-year standard via Cynosure with extended contracts; the Cynosure-Lutronic merger and DEKA/El.En. relationship shifts make parts-and-service continuity a live diligence question.
Resale & used market
Plentiful and cheap — the 2018 crackdown plus soft trial data pushed many units onto broker listings at $15-50k; fine value for a qualified gyn buyer, but expect slow liquidation if you resell.
Chains using this device
No confirmed chain deployments recorded yet.
Owner reviews
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Alternatives
History
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
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