Non-Surgical Vaginal Rejuvenation: Options, Cost and Safety

“Vaginal rejuvenation” is a marketing umbrella, not one treatment.

The name is put on several different non-surgical procedures — laser treatments, radiofrequency (RF) energy devices and platelet-rich plasma (PRP) injections — marketed for menopause symptoms such as dryness, for urinary incontinence and for sexual function.

The devices themselves work differently; the shared name is the market’s, not one technology’s.

Whatever brand name a treatment menu uses, the devices share one regulatory fact: on July 30, 2018, FDA warned that these devices were being marketed for “vaginal rejuvenation” even though the agency had not cleared or approved any device for those uses.

We did not find a later FDA clearance for these uses in the sources reviewed for this guide.

This guide covers only the non-surgical side — what each category is, what the trials actually show, what FDA has said, what it costs and how to vet a provider before you book.

Under the shared label, the menus break down into lasers, radiofrequency devices and PRP injections — plus one chair that is related but cleared for something else.

• Laser. Devices that use laser energy. The controlled trial you will read about below used a fractional CO2 laser, with three treatments per participant, so the laser evidence in this guide is specific to that type.
• Radiofrequency (RF). Devices that use radiofrequency energy. FDA’s 2018 statement covered “lasers and other energy-based devices,” which is the bracket the RF tools sold for this purpose fall into.
• PRP injections. Injections of platelet-rich plasma (PRP) are also sold under this label. PRP is not an energy device, and FDA’s 2018 warning was about lasers and other energy-based devices. We found no FDA clearance or approval of PRP for vaginal rejuvenation or tightening in the sources reviewed for this guide.

A related device does carry a real clearance in this part of the body — just not for this.

BTL’s pelvic-floor chair, which BTL markets as Emsella, was cleared on December 13, 2016 as a non-implanted electrical continence device: electromagnetic stimulation of the pelvic floor to treat urinary incontinence in women.

A later version was cleared in 2018 for male and female urinary incontinence.

BTL’s own quoted figures put a session at 28 minutes and a typical course at six sessions, twice a week.

The clearance covers urinary incontinence — not vaginal tightening, sexual function or “rejuvenation,” which were outside every device’s cleared or approved uses as of FDA’s 2018 statement.

Providers market these treatments for a short list of problems: vaginal dryness and other menopause symptoms, urinary incontinence and sexual function.

FDA’s 2018 statement named exactly those uses when it said no device had been cleared or approved for them — so on the clearance record, none of the marketed uses is an established use of any device.

For menopausal vaginal symptoms, established medical options exist.

FDA-approved menopausal hormone products such as Premarin tablets are indicated for moderate-to-severe vulvar and vaginal atrophy due to menopause, among other uses.

And for vaginal dryness and genitourinary symptoms alone, the Menopause Society’s 2022 position statement recommends low-dose vaginal estrogen or other local therapies — vaginal DHEA or oral ospemifene — when over-the-counter products are not enough and systemic therapy is not otherwise indicated.

For urinary incontinence, there is a cleared device in this space: the Emsella chair described above, whose cleared use is electromagnetic pelvic-floor stimulation for urinary incontinence.

For sexual function, FDA’s 2018 statement covered that use too: no device was cleared or approved for it, and we found no FDA clearance or approval of PRP for it in the sources reviewed.

Which treatment, if any, makes sense for your symptoms is a question for a licensed clinician who can examine you and knows your medical history — not a question this guide, or a treatment menu, can answer.

A 2021 randomized, double-blind, sham-controlled trial published in JAMA tested the laser version of the claim. 85 postmenopausal women received three fractional CO2 laser treatments or a sham procedure; at 12 months, the laser group showed no significant improvement in vaginal symptoms compared with sham.

The design is the point: a sham procedure lets researchers separate a device’s physical effect from placebo responses and ordinary month-to-month change, and the laser did not separate itself from the sham.

The finding is narrow — one fractional CO2 laser, in postmenopausal women, for vaginal symptoms — and it does not test every device for every purpose.

But it is strong evidence against assuming that laser treatment works as marketed for those symptoms, and it is the kind of study a provider should be able to discuss before selling a package.

Before-and-after photos and patient reviews are individual stories, not evidence of cause.

That is exactly why controlled trials compare an active treatment against a fake one: symptoms can improve after any procedure, including a sham.

The FDA warning predated that trial.

On July 30, 2018, the agency warned that lasers and other energy-based devices were being marketed for “vaginal rejuvenation” — menopause symptoms, urinary incontinence, sexual function — with serious risks and inadequate evidence behind them, and that it had not cleared or approved any device for those uses.

The same month, FDA sent letters about inappropriate “vaginal rejuvenation” marketing to seven manufacturers: Alma Lasers, BTL Industries, Cynosure, InMode, Sciton, Thermigen and Venus Concept.

The letters concerned marketing; they were not enforcement findings of wrongdoing.

As of that statement, no laser, RF or other energy-based device was cleared or approved for these uses, and we did not find a later FDA clearance for them — or any FDA clearance or approval of PRP for vaginal rejuvenation or tightening — in the sources reviewed for this guide.

If a menu or a consultation describes a device as cleared “for vaginal tightening,” ask to see the clearance and read its stated indication yourself.

We cannot quote you a reliable national price, because our sources hold none: the research behind this guide found no national survey or published average fee for laser, radiofrequency or PRP vaginal treatments.

Treat any dollar figure you see advertised as one practice’s own number — our research found no market-wide standard to check it against.

When you compare practices, ask what the whole course costs, not one visit.

The questions worth putting: the price per session; how many sessions the provider recommends and why; whether maintenance sessions are part of the plan; and what is included — numbing, follow-up visits, touch-ups.

Pricing can be per session or per package, so ask which one you are being quoted before comparing numbers.

One money note comes from the IRS: Publication 502 says cosmetic procedures that improve appearance without promoting proper body function or treating a disease are generally not deductible medical expenses, naming hair transplants and liposuction as examples.

How the rules apply to any specific treatment is not something this guide can judge — ask the practice how it documents the service, and ask a tax professional about your own situation.

Whatever the quote, weigh it against the evidence above: in the 2021 sham-controlled trial, fractional CO2 laser showed no significant improvement in vaginal symptoms over sham in postmenopausal women, and FDA said in 2018 that the safety and effectiveness of these devices for these uses had not been evaluated or confirmed.

A practice should be able to tell you what evidence it relies on — and no result is guaranteed.

Because FDA’s 2018 statement says none of the marketed uses was cleared or approved, this category deserves extra vetting.

Before you book anywhere, put these to the practice:

• Who will perform or operate the device, and with what license? Ask who handles the treatment, what training they have on that specific device and which clinician oversees your care.
• What is the device cleared or approved for? Ask to see the FDA clearance or approval and read the stated indication yourself, rather than relying on a menu description.
• What controlled evidence supports it for my problem? A practice should be able to name the studies behind its claims — and to discuss the 2021 trial in which 85 postmenopausal women were randomized to fractional CO2 laser or sham, and the laser group showed no significant improvement at 12 months.
• What can go wrong, and who handles it? FDA’s review found numerous cases of vaginal burns, scarring, pain during sex and recurring or chronic pain. Ask what the practice would do if that happened and who you would contact.
• What does the full course cost? The per-session price, the recommended number of sessions, maintenance, and what happens if you stop after one.

Two of our guides go deeper on this. How to choose a med spa works through credentials, oversight and the questions worth asking before any treatment, and our guide to med spa laws covers who can inject and who must supervise, state by state.

None of this tells you whether to have a treatment — that is a decision to make with a licensed clinician who knows your history.

It should tell you whether a particular practice has earned your appointment.