Vaginal rejuvenation advertising rules: what FDA says

Laser and radiofrequency treatments marketed as vaginal “rejuvenation” are offered by gynecology practices, menopause clinics, urogynecology and pelvic health practices, and med spas. Device sellers pitch them as a cash-pay service line for dryness, laxity, leaks and sexual function. Before a practice writes a page or an ad for one, it should know what FDA has said about these uses, what the device in the room is actually cleared for, and how the FTC Act applies to the claims.

This guide covers FDA’s 2018 warning, how to check your device’s cleared uses, which claims to drop, and how to handle patient stories and audiences such as people after cancer treatment. For device wording across specialties, see our guide to medical device marketing claims. Practices treating leaks should also read our guide to bladder clinic marketing, and practices treating menopause symptoms our guide to menopause clinic marketing.

This is general information, not legal or medical advice. Sources cited were checked on November 1, 2026: the FDA safety communication on energy-based devices for vaginal “rejuvenation” (issued July 30, 2018, updated November 20, 2018, content current as of March 3, 2021) and the FDA Commissioner’s statement of July 30, 2018 (updated August 2, 2018), both read through Internet Archive copies because their fda.gov addresses returned “page not found” that day; FDA’s device classification data through openFDA (data last updated October 19, 2026); 21 CFR 884.4550, 884.4120, 878.4810, 807.97 and 801.4 and 16 CFR 255.2 in the eCFR version as of October 29, 2026; 21 USC 396 and 15 USC 45, 52 and 55 in the Cornell LII text of the U.S. Code; and the FTC Health Products Compliance Guidance (December 2022). We did not read any device maker’s labeling, the medical literature, professional society statements, ad platform policies or any state law on who may perform these procedures.

The short version

FDA has said it has not cleared or approved these uses. Its 2018 safety communication says FDA has not cleared or approved any energy-based medical device for vaginal “rejuvenation” or vaginal cosmetic procedures, or for vaginal symptoms related to menopause, urinary incontinence or sexual function.
FDA named risks. The same communication says these treatments may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain.
The devices are cleared for other things. FDA describes them as devices, commonly radiofrequency or laser, cleared for general gynecologic tool uses such as destroying abnormal or pre-cancerous cervical or vaginal tissue and genital warts. That clearance does not cover dryness, laxity, leaks or sexual function.
We found no newer FDA device type for these uses. Our search of FDA’s classification data on November 1, 2026 for device names containing vaginal, vagina, vulvar or laxity returned 21 device types, none of them an energy-based treatment for those symptoms.
Your ads can create a new intended use. Under 21 CFR 801.4, intended use can be shown by advertising matter and statements of a seller, and a distributor or seller who intends different uses must supply labeling for them.
FTC rules still apply. Health claims need competent and reliable scientific evidence, and patient stories count as your claims (15 USC 45, 52, 55; 16 CFR 255.2).

What FDA said in 2018

On July 30, 2018, FDA issued a safety communication titled “FDA Warns Against Use of Energy-Based Devices to Perform Vaginal ‘Rejuvenation’ or Vaginal Cosmetic Procedures.” It calls vaginal “rejuvenation” “an ill-defined term” and lists the symptoms and conditions the term is used to describe: vaginal laxity; vaginal atrophy, dryness or itching; pain during sexual intercourse; pain during urination; and decreased sexual sensation. It says: “To date, we have not cleared or approved for marketing any energy-based devices to treat these symptoms or conditions, or any symptoms related to menopause, urinary incontinence, or sexual function.”

Under FDA Activities, the communication says FDA was aware that “certain device manufacturers may be inappropriately marketing their energy-based devices” for these uses, that it had contacted them, and that it would “continue to actively monitor promotional materials, including materials on the internet.” The Commissioner’s statement the same day says FDA had notified seven manufacturers and asked them to address its concerns within 30 days. It also says some devices were being marketed to women who had completed treatment for breast cancer and had symptoms of early menopause, and calls that marketing “egregious”.

Both pages carry dates from 2018 to 2021, and their fda.gov addresses returned “page not found” when we checked on November 1, 2026. A page moving is not a change in FDA’s position, so we searched FDA’s device classification data the same day. The search, for device names containing vaginal, vagina, vulvar or laxity, returned 21 device types such as specula, pessaries, dilators, mesh and a powered vaginal muscle stimulator. None is an energy-based device for dryness, laxity, sexual function or menopause symptoms. Our guide to bladder clinic marketing reports the same result for laser and radiofrequency treatment of leaks. Check again before you publish, and check your own device’s record.

What your device is actually cleared for

The device types FDA’s communication describes are general gynecologic and surgical tools. The regulations for some of them, in the eCFR version as of October 29, 2026:

Gynecologic surgical laser (21 CFR 884.4550). “A continuous wave carbon dioxide laser designed to destroy tissue thermally or to remove tissue by radiant light energy,” used “only in conjunction with a colposcope as part of a gynecological surgical system.” Class II.
Gynecologic electrocautery (21 CFR 884.4120). A device that destroys tissue with an electrically heated probe, used “to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation.” Class II.
Laser surgical instrument for general and plastic surgery and dermatology (21 CFR 878.4810). A carbon dioxide laser “intended to cut, destroy, or remove tissue,” or an argon laser for dermatology. Class II.

A platform sold to a practice may have been cleared under one of these types or another one. Ask the seller for the 510(k) number, look it up in FDA’s 510(k) database, and read the indications for use. If the indications do not name dryness, laxity, incontinence or sexual function, your marketing cannot claim them as cleared uses. Under 21 CFR 807.97, a 510(k) clearance also does not denote official approval, so “FDA-approved” is wrong for a cleared device even for its cleared use.

Claims to drop

These phrases appear in vaginal treatment marketing. Each one claims a use FDA says it has not cleared or approved, or a result that needs evidence you are unlikely to have:

“FDA-cleared” or “FDA-approved” vaginal rejuvenation, tightening or laxity treatment. FDA’s communication says no energy-based device has been cleared or approved for these uses.
“Non-hormonal treatment for vaginal dryness” or “menopause relief”. Vaginal atrophy and dryness and menopause symptoms are on FDA’s list. The Commissioner’s statement says these products may appeal to people who cannot use certain FDA-approved treatments for dryness and are looking for non-hormonal options, which is why this claim matters.
“Stop leaks without surgery” or “cures incontinence”. Urinary incontinence is on FDA’s list.
“Improves sensation”, “better sex” or “restores intimacy”. Decreased sexual sensation and pain during sex are on FDA’s list.
“Painless”, “no downtime”, “no risks”. FDA lists burns, scarring, pain during sex and chronic pain. Leaving out material facts can make an ad misleading (15 USC 55(a)(1)).
“Clinically proven” or a percentage of satisfied patients. The FTC Health Products Compliance Guidance says health benefit claims need competent and reliable scientific evidence, which it says generally means randomized, controlled human clinical testing. Satisfaction surveys and a manufacturer brochure are not that.

Off-label use and what you may say

21 USC 396 says the Federal Food, Drug, and Cosmetic Act does not limit “the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.” It also says this “shall not change any existing prohibition on the promotion of unapproved uses of legally marketed devices.” Whether a clinician uses a device off-label is a matter of medical judgment and state practice rules, which this guide does not address. Advertising that use is a separate question.

21 CFR 801.4 says a device’s intended use is shown by the objective intent of the people responsible for its labeling, and that this intent “may, for example, be shown by labeling claims, advertising matter, or oral or written statements.” It adds that if “a packer, distributor, or seller intends an article for different uses” than the manufacturer, that seller “is required to supply adequate labeling in accordance with the new intended uses.” A practice page that sells a device treatment for dryness or laxity is advertising matter for a use the device’s labeling does not cover.

If your practice treats vaginal symptoms, a safer approach is to market the evaluation, not the device: a visit to assess dryness, pain, leaks or pelvic floor symptoms, where a clinician explains the treatment options with FDA-approved or FDA-cleared uses, their risks, and any off-label options. If you mention an energy-based device at all, say plainly that FDA has not cleared or approved energy-based devices for these symptoms, and link to FDA’s statement. Have a health care attorney review the page.

Audiences that need extra care

The Commissioner’s statement singles out marketing to women who completed breast cancer treatment and have symptoms of early menopause. Ads that target cancer survivors, people after childbirth or people in menopause with device treatment offers are the cases FDA called out. Do not build audiences, landing pages or email lists around a cancer history for these treatments. Separately, any targeting that uses health information from your own patient records raises HIPAA marketing questions; see our guide to HIPAA marketing rules.

Patient stories and before and after content

Under 16 CFR 255.2(a), an ad using consumer endorsements is read as representing that the product is effective for the purpose shown, and the advertiser needs substantiation as if it had made the claim directly. Under 16 CFR 255.2(b), an endorsement about a central attribute is likely to be read as representative of what consumers generally achieve, unless the ad clearly and conspicuously discloses the generally expected performance. A patient video saying a laser treatment ended their dryness or leaks is your dryness or leaks claim, for a use FDA says it has not cleared or approved. Ask for reviews about the visit, the staff and the explanation of options instead, and see our guide to patient testimonials and before-and-after photos.

An example (made up)

This illustration is invented to show how the rules fit together. A med spa’s landing page reads: “FDA-cleared vaginal rejuvenation. Tighten, restore moisture and stop leaks in 3 painless sessions. Perfect for breast cancer survivors who can’t use hormones. 95% of our clients would recommend it.” Its paid social campaign targets an audience built around breast cancer interests.

Fixes: the page drops “FDA-cleared vaginal rejuvenation”, “tighten”, “restore moisture” and “stop leaks”, because FDA’s communication says no energy-based device is cleared or approved for laxity, dryness or incontinence. “Painless” and “3 sessions” go, and the page names the risks FDA lists. The breast cancer line and the cancer-based audience go. The 95% figure goes, because a recommendation survey is not evidence that the treatment works. The page becomes an offer of a consultation with a clinician about vaginal and pelvic symptoms and the treatment options for them, with a sentence saying FDA has not cleared or approved energy-based devices for these symptoms and a link to FDA’s statement. The med spa also checks whether its state allows the procedure in its setting, and with which clinician.

Checklist

You have your device’s 510(k) number and have read its indications for use in FDA’s database.
No “FDA-cleared” or “FDA-approved” claim for vaginal rejuvenation, tightening, laxity, dryness, menopause symptoms, incontinence or sexual function.
No “FDA-approved” for any 510(k) device (21 CFR 807.97).
No claims for uses outside your device’s labeling, including on social posts and in staff scripts (21 CFR 801.4; 21 USC 396).
Risks FDA lists are not hidden; no “painless”, “no downtime” or “risk-free” (15 USC 55(a)(1)).
No success rates, “clinically proven” or satisfaction figures used as proof that the treatment works (15 USC 52; FTC guidance).
No ads or audiences aimed at cancer survivors for these treatments.
Patient stories limited to the visit and care (16 CFR 255.2).
FDA’s classification data and your device’s record checked again before publishing.
Who may perform the procedure, and where, checked against your own state’s rules.

How we help

We build service pages and campaigns for gynecology, menopause, urogynecology, pelvic health and aesthetic practices, with device claims checked against the sources above: website design, healthcare SEO for symptom and condition searches, and lead generation campaigns that promote consultations rather than unapproved device uses. We do not give legal opinions on device status or off-label use, and we are not a law firm.

Is laser vaginal rejuvenation FDA-approved?

No. FDA’s 2018 safety communication says FDA has not cleared or approved any energy-based medical device for vaginal rejuvenation or vaginal cosmetic procedures, or for vaginal symptoms related to menopause, urinary incontinence or sexual function. Our search of FDA’s classification data on November 1, 2026 found no device type that changes that.

Our device is FDA-cleared. Can we say so?

Only for its cleared use, and only as “FDA-cleared”, not “FDA-approved” (21 CFR 807.97). FDA describes these devices as cleared for general gynecologic tool uses such as destroying abnormal cervical or vaginal tissue and genital warts. Saying “FDA-cleared” next to a vaginal rejuvenation offer implies a clearance for that use.

Can we offer the treatment off-label?

21 USC 396 leaves clinicians free to use legally marketed devices off-label within a practitioner-patient relationship, subject to state rules. It does not change any prohibition on promoting unapproved uses, and 21 CFR 801.4 says advertising can show a new intended use. Market the consultation, not the off-label use, and have an attorney review the page.

Can we market it to breast cancer survivors?

FDA’s Commissioner called marketing these devices to women treated for breast cancer, who may have early menopause symptoms, egregious. Do not target ads, pages or email lists at cancer survivors for these treatments.

Can we share patient reviews about results?

A review saying the treatment fixed dryness, laxity or leaks is your claim under 16 CFR 255.2, for a use FDA says it has not cleared or approved. Use reviews about the visit and the care instead.

Sources

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