Cynosure MonaLisa Touch

Fractional CO2 (gynecologic) · DEKA SmartXide fractional CO2 with intravaginal probe

CurrentFDA status under reviewBe the first to review

What it's actually cleared for: The underlying SmartXide CO2 is 510(k)-cleared as a surgical laser for incision, excision, ablation, vaporization, and coagulation of soft tissue across specialties including gynecology — it has NEVER been cleared for "vaginal rejuvenation," GSM, dyspareunia, or sexual function, and Cynosure was among the seven companies receiving FDA's July 2018 letters on exactly that gap. Every website claim must track the surgical-tool language; verify K-numbers on accessdata.fda.gov.

Last verified: August 6, 2026 · How we verify

New: $100k–$140k|Used: $20k–$50kmarket estimate, no email required

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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 reviewRegulatory status not yet verified

What it's actually cleared for:

The underlying SmartXide CO2 is 510(k)-cleared as a surgical laser for incision, excision, ablation, vaporization, and coagulation of soft tissue across specialties including gynecology — it has NEVER been cleared for "vaginal rejuvenation," GSM, dyspareunia, or sexual function, and Cynosure was among the seven companies receiving FDA's July 2018 letters on exactly that gap. Every website claim must track the surgical-tool language; verify K-numbers on accessdata.fda.gov.

Regulatory data is compiled from public FDA 510(k) records and may lag recent clearances. Always confirm status with the manufacturer before purchase.

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.