The short version

FDA warned in 2018 that no energy-based device is cleared or approved for vaginal rejuvenation and that serious harms were reported. Later sham-controlled trials have not shown the promised benefit for menopausal symptoms.

What the cost figure means

No reliable national estimate. Sold as a series of 3 or more sessions plus maintenance, self-pay. No society publishes an average.

Advertised prices on file

$750–$1,100 per session; $2,000–$4,350 per series

Forma V and ThermiVa sessions and three-session series across three menus.

Read from 3 published U.S. clinic menus on September 1, 2026. A convenience sample, not a national survey: prices vary by city and provider, packages are usually cheaper per session, and menus change without notice.

Total course = per-session fee × planned sessions + consultation + product, cartridge, or serum + anesthesia or facility + prescriptions and aftercare + expected maintenance. Ask for the plan price in writing.

Healing and results timeline

Appointment
About 20–45 minutes
Downtime
None to a few days of discomfort; abstain from intercourse briefly
Healing
Mild discharge, spotting, or discomfort for a few days after laser; radiofrequency usually causes none.
Results appear
Claimed at weeks to months; not consistently shown against sham
Duration and maintenance
Marketed as needing annual maintenance

Benefits, limitations, and risks

Realistic benefits

  • Non-surgical
  • Little downtime
  • Some patients report symptom relief in uncontrolled studies

Limitations

  • Not shown to beat sham treatment
  • Series and maintenance cost
  • Marketed uses exceed device clearances

Common effects

  • Discharge or spotting
  • Burning or discomfort
  • Temporary swelling

Serious risks

  • Burns and scarring
  • Persistent pain or pain with intercourse
  • Recurring symptoms or infection

Candidacy and pause signs

Usually considered for: The evidence does not identify a group that clearly benefits. Menopausal symptoms and urinary leakage have better-supported treatments to try first.

Pause before booking if

You have not been evaluated for the underlying symptom, you are being promised tightening or sexual enhancement, you have an active infection or pelvic floor disorder, or the provider is not a gynecologist or trained physician.

Operator, setting, and regulation

Who performs it in the U.S.: Gynecologists, urogynecologists, and some dermatologists or plastic surgeons; the treatment is often promoted in medical spas, where the FDA warning is most relevant.

Regulatory status: FDA stated in July 2018 that it had not cleared or approved any energy-based device for vaginal rejuvenation and sent letters to manufacturers about deceptive marketing. Devices remain cleared only for their general gynecologic indications.

Rules differ by state and by country. A product approved in one market may be unapproved in another, and the same device can be used within or outside its cleared indication.

Questions to ask before you pay a deposit

  1. What is this device actually cleared for, and how does that match what you are promising?
  2. What sham-controlled evidence supports it for my symptom?
  3. Have we tried the standard treatment for my symptom first?

Open the complete safety checklist →

Sources on file

These links support the claims above. Reviewed September 1, 2026. Where a figure comes from a survey, the caveat is in the file, not in a footnote.

  1. U.S. FDA — letters to industry, including 2018 energy-based 'vaginal rejuvenation' device letters (opens in a new tab)InMode letter dated July 24, 2018
  2. Am J Obstet Gynecol 2023 — vaginal histology before and after fractional CO2 laser: double-blind sham-controlled RCT (PubMed) (opens in a new tab)
  3. Climacteric 2025 — laser for genitourinary syndrome of menopause: what we know (PubMed) (opens in a new tab)
  4. American Society for Dermatologic Surgery — vaginal rejuvenation devices (opens in a new tab)
  5. American Society of Plastic Surgeons — vaginal rejuvenation (opens in a new tab)