Reviewed by Ashley Harwyn, PA-C, ABAAHP | A4M Board Certified | Updated October 2, 2026
Vaginal rejuvenation is a marketing umbrella, not a diagnosis. Here is what the evidence genuinely supports, what the FDA has warned against, and what usually should come first.
We offer IntimaLase and the O-Shot at Solcara, and you will hear exactly where each one stands on the evidence. The goal here is not to talk you into or out of anything. It is to make sure that if you choose an elective procedure, you choose it with the real numbers in front of you, and that we have first ruled out a condition we could actually treat.
- In 2018 the FDA warned against energy-based devices (laser and radiofrequency) marketed for vaginal “rejuvenation,” saying their safety and effectiveness for that use have not been established, and citing reports of burns, scarring, and painful sex.[1]
- In a double-blind, sham-controlled trial, fractional CO2 laser was no better than a fake procedure for postmenopausal vaginal symptoms at 12 months. Both groups improved, which points to a large placebo effect.[2]
- Evidence specific to IntimaLase, an Er:YAG laser, is preliminary and low quality, with no sham-controlled trial confirming it works.[7]
- The O-Shot (platelet-rich plasma) is not FDA-approved for sexual function or incontinence, and the published evidence is a handful of mostly uncontrolled studies.[5]
- If you have a real condition (menopausal dryness, stress incontinence, or lichen sclerosus), proven first-line treatments exist and should usually come first.[6]
- A responsible clinic examines you and names the problem before it reaches for a device, which is how we do it in Mount Pleasant and Charleston.
What vaginal rejuvenation actually means
The single most useful thing to understand before comparing anything: “vaginal rejuvenation” is a marketing category, not a medical diagnosis.[4] The term gets used for menopausal dryness, mild urinary leakage, the appearance of the labia, and a vague sense of laxity, and those are completely different issues with completely different answers. The first real step is to separate a treatable medical condition from an elective cosmetic goal, because the right path is not the same for the two.
The American College of Obstetricians and Gynecologists is direct about this: cosmetic vaginal procedures are often performed without a clear medical indication and without adequate data on safety or effectiveness, and patients deserve to be counseled on exactly that.[4] That is not a reason to feel any shame about wanting to address a symptom that bothers you. It is a reason to insist on a real evaluation first, so you are treating the actual problem rather than paying for a procedure that may not do what the advertisement implies.
What women ask Ashley about rejuvenation
Ashley Harwyn, PA-C explains what women usually mean when they ask about vaginal rejuvenation, and what she checks for before any procedure is on the table.
What the evidence on laser and IntimaLase shows
Laser rejuvenation, including Fotona's IntimaLase (an Er:YAG laser) and fractional CO2 devices, is marketed to stimulate collagen in the vaginal wall and improve laxity, dryness, and mild leakage. The idea sounds reasonable, and that is exactly what gives the advertising its pull. Plausible is not the same as proven, and this is where the evidence gets uncomfortable for the industry.
Start with the FDA. In 2018 it issued a safety communication warning against energy-based devices marketed for vaginal rejuvenation, stating plainly that their safety and effectiveness for these uses have not been established, and noting reports of vaginal burns, scarring, and painful intercourse.[1] These lasers are FDA-cleared for certain gynecologic uses, such as destroying abnormal or precancerous tissue, but they are not cleared for rejuvenation or for treating menopause, incontinence, or sexual-function symptoms.[1] The agency went further and acted against device makers marketing these products deceptively for vaginal cosmetic uses.[3] A sales page will blur that distinction. We will not.
Then there is the strongest single piece of evidence, a rigorous trial. In a double-blind, randomized study, women with postmenopausal vaginal symptoms received either fractional CO2 laser or an identical-feeling sham procedure, and at 12 months the laser was not better than the sham.[2] Both groups improved, which tells you how powerful placebo and expectation are for these symptoms. Evidence specific to the Er:YAG IntimaLase device is thinner still, limited to small, often manufacturer-linked studies with no sham-controlled trial confirming that it works.[7] None of this means a laser can never help anyone. The accurate word is “unproven,” and a guarantee of results goes well beyond what the data supports.
That these lasers are FDA-cleared for certain gynecologic uses, such as destroying abnormal tissue, and that the real conditions behind the symptoms (menopausal dryness, stress incontinence, lichen sclerosus) have proven, effective treatments.
That energy-based devices are proven safe and effective for rejuvenation. The FDA has not cleared them for it, and in a sham-controlled trial the laser was no better than a fake procedure at 12 months.
IntimaLase, the O-Shot, and surgery, compared
With the evidence laid out, the options line up clearly on what matters: how invasive each is, how strong the evidence is, and what it realistically does. The table below compares them honestly, so you can see what you would actually be choosing.
| Option | How invasive | Evidence | Honest bottom line |
|---|---|---|---|
| Laser (IntimaLase, CO2) | Non-surgical, in-office | Not FDA-cleared for this; sham trial negative at 12 months | Unproven for rejuvenation; realistic expectations only |
| O-Shot (PRP) | Injection, minimal downtime | Preliminary, mostly uncontrolled; not FDA-approved | Low-risk but unproven for sexual function |
| Surgery (labiaplasty, vaginoplasty) | Most invasive, real recovery | A true anatomical change; limited outcome data | Real change, real risk, not medically indicated for most |
Six things to consider first
Check each one that describes you. With more checks, a proper exam matters more before any procedure, because several of these are treatable conditions, not cosmetic ones.
Two things stand out when you read the table honestly. First, invasiveness and evidence do not line up the way you might hope: the least invasive options, laser and PRP, are also the least proven, while the most proven anatomical change comes from the most invasive option. Second, none of these is a first-line treatment for a medical problem. The O-Shot, which uses platelets concentrated from your own blood, has a reasonable safety profile but thin efficacy data: a systematic review found mostly uncontrolled studies and judged the overall evidence low quality.[5] You can read our honest page on the O-Shot for the detail. If your real issue is dryness, leakage, or a skin condition, the next section matters more than this table does.
Treat the real condition first
This is the part a rejuvenation clinic has no incentive to tell you: many of the symptoms that send women looking for rejuvenation are real medical conditions with proven, often inexpensive first-line treatments. Treating the condition usually works better than treating the marketing category.
If your symptoms are vaginal dryness, burning, or pain from menopause, that is genitourinary syndrome of menopause, and low-dose vaginal estrogen is an effective, guideline-recommended treatment, with over-the-counter moisturizers and lubricants first-line for milder cases.[6] Our guide to whether vaginal estrogen is safe covers the evidence, including for women worried about hormones, and a review of your hormones and labs is often the right starting point. If your issue is leaking urine with a cough or sneeze, that is stress urinary incontinence, and the evidence-based first step is pelvic floor physical therapy, with pessaries and established surgical options available, none of which is a laser or an injection. And if you have chronic itching, whitening, or thinning of the vulvar skin, that can be lichen sclerosus, which needs a prescription steroid and ongoing care, because untreated it carries a small cancer risk. These are problems to diagnose and treat properly, not to laser or inject away.
Not sure whether your symptom is cosmetic or a treatable condition? That is the question to answer before any procedure. Call 843-981-0870 and we will examine you, identify what is going on, and begin with whichever treatment the evidence supports for it.
Getting evaluated in Mount Pleasant or Charleston
Before choosing any procedure, get examined by someone with no stake in which one you pick. That exam should identify any diagnosable condition, such as genitourinary syndrome of menopause, treat it with what is proven, and only afterward weigh elective options against the published trials.
Solcara follows that sequence. A visit usually starts with a conversation about symptoms and history, followed by an exam. These visits are offered in Mount Pleasant and at The Longevity Club downtown. Ashley Harwyn, PA-C will point out plainly where the evidence is thin. If you have a treatable condition, we start there. If an elective option is still what you want once its limits are clear, we will do it carefully, and the relevant laboratory work comes before any decision.
The O-Shot at Solcara
What platelet-rich plasma does and does not do, stated honestly. Read The O-Shot at Solcara.
Is Vaginal Estrogen Safe?
The evidence-based first-line for menopausal dryness. Read Is Vaginal Estrogen Safe?.
Treatment for Urinary Stress Incontinence
Where leaking should actually be assessed. Read Treatment for Urinary Stress Incontinence.
Ashley Harwyn, PA-C
PA-C, ABAAHP · Founder, Solcara Health
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Be taken seriously, and told the truth
Book an evaluation at The Longevity Club, 163 Rutledge Avenue downtown, or our Mount Pleasant office.
BOOK A CONSULTATION →Or call 843-981-0870
Ashley Harwyn, PA-C, ABAAHP
Founder, Solcara Health · Diplomate, American Board of Anti-Aging Health Practitioners (ABAAHP)
Ashley has practiced medicine for more than fifteen years. Her path into it began at home, with a family member born with a congenital heart defect and a childhood spent watching how much the quality of a clinician's attention could change the shape of a life. She has since practiced across a range of settings, including medical mission work in Uganda, before founding Solcara to build the kind of practice she kept wishing existed, one that treats women as whole people and tells them the truth about what the evidence does and does not support.
Full bio →References
FDA safety communication and commissioner statement on energy-based vaginal devices, the Li et al JAMA 2021 sham-controlled laser trial, ACOG Committee Opinion 795, a 2023 systematic review of PRP, the 2020 NAMS position statement on genitourinary syndrome of menopause, and a 2025 Climacteric review, each accessed October 2, 2026.
- U.S. Food and Drug Administration. FDA Warns Against Use of Energy-Based Devices to Perform Vaginal Rejuvenation or Vaginal Cosmetic Procedures: FDA Safety Communication. July 2018. FDA.gov Archive copy. fda.gov
- Li FG, Maheux-Lacroix S, Deans R, et al. Effect of Fractional Carbon Dioxide Laser vs Sham Treatment on Symptom Severity in Women With Postmenopausal Vaginal Symptoms: A Randomized Clinical Trial. JAMA. 2021. jamanetwork.com
- U.S. Food and Drug Administration. Statement on Efforts to Safeguard Women's Health from Deceptive Health Claims and Significant Risks Related to Devices Marketed for Vaginal Rejuvenation. July 2018. FDA.gov Archive copy. fda.gov
- American College of Obstetricians and Gynecologists. Elective Female Genital Cosmetic Surgery (Committee Opinion No. 795). 2020. acog.org
- Dankova I, Pyrgidis N, Tishukov M, et al. Efficacy and Safety of Platelet-Rich Plasma Injections for the Treatment of Female Sexual Dysfunction and Stress Urinary Incontinence: A Systematic Review. Biomedicines. 2023. mdpi.com
- The North American Menopause Society. The 2020 Genitourinary Syndrome of Menopause Position Statement of The North American Menopause Society. Menopause. 2020. isswsh.org
- Phillips C, Hillard T, Salvatore S, et al. Lasers for Genitourinary Syndrome of Menopause: What We Know and What We Need to Know. Climacteric. 2025. tandfonline.com
Medical Disclaimer: This page is for educational and informational purposes only and does not constitute medical advice, and reading it does not create a patient-provider relationship. It describes general medical information and categories of care, not a recommendation that any individual start, stop, or change any test, treatment, or medication. Any diagnosis or treatment decision requires evaluation by a qualified, licensed clinician who knows your personal and family history. Consult a qualified healthcare provider before making medical decisions. Information reflects sources available as of October 2, 2026.
Ashley Harwyn, PA-C, ABAAHP, is a Diplomate of the American Board of Anti-Aging Health Practitioners (ABAAHP) through A4M and the founder of Solcara Health. Solcara serves South Carolina from Downtown Charleston (163 Rutledge Ave, Ste 202, The Longevity Club) and Mt. Pleasant (496 Bramson Ct, Ste 120).




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