"Vaginal rejuvenation" is a marketing phrase, not a cleared indication. That single fact explains why this category carries more risk than almost anything else on an aesthetic practice's menu — and why rewriting the page usually isn't enough.
In July 2018 FDA wrote to manufacturers of energy-based devices — lasers and radiofrequency systems — being marketed for these uses. The language in those letters is the part worth reading, because it is FDA describing its own files:
"we have conducted a review of our files, and have been unable to identify any Food and Drug Administration (FDA) clearance or approval for the [devices] as currently marketed ... for therapeutic use in the treatment of sexual dysfunction, vaginal rejuvenation and urinary stress inconsistence"
— FDA to Inmode MD Ltd., 24 July 2018 (doc. CPT1800704)
Each manufacturer was asked to produce a clearance number, or justify why none was needed, within 30 days. Letters went to several manufacturers in this space. They remain published on FDA's website.
A sourcing note, because it matters. FDA also issued a safety communication on this topic that has been widely quoted ever since. As of this writing that page is no longer retrievable on fda.gov — the address FDA's own warning letters point to returns "not found," and it does not appear on FDA's current safety-communications index. We've built this article on the letters, which are still published. If you cite the safety communication in your own materials, check the link first.
Most compliance findings are about phrasing: say it differently and the problem goes away. This one isn't.
A device clearance covers specific indications. If the indication you're advertising isn't in it, you are promoting an uncleared use — regardless of how carefully the sentence is built. Softening "treats incontinence" to "may help with incontinence" doesn't fix it, because the claim category is the problem, not the hedge.
| Safe | Crosses over |
|---|---|
| "Ask our physician whether this treatment is appropriate for you" | "Treats urinary incontinence" / "stops leaking" |
| Describing the procedure and what the visit involves | "Vaginal rejuvenation" as a service name |
| "A consultation to discuss your symptoms and the options" | "Relieves menopause symptoms" / "restores sexual function" |
| Directing symptom questions to a clinical conversation | Testimonials implying a functional cure |
Related: "off-label" is not available to you here — that defense applies to approved products used differently, not to uncleared indications.
Educational information about publicly available regulatory frameworks — not legal advice. Confirm your specific device's clearance before relying on anything here.
This article is educational content about publicly available regulatory guidance. It is not legal advice; consult healthcare counsel for guidance specific to your practice.
Run a free AI compliance scan — your score and sample findings in about a minute.
Analyze My Website — Free