FemiWave is a branded treatment that uses low-intensity acoustic wave therapy (also called shockwave therapy) applied to vaginal tissue with the goal of improving women’s sexual function, sensation, and natural lubrication. It falls under a broader category of energy-based devices marketed for vaginal rejuvenation, a space that has drawn both consumer interest and regulatory scrutiny in recent years.
How FemiWave Works
During a FemiWave session, a provider applies a wand-like device to the treatment area. The device delivers mild, pulsed sound waves into the tissue. These low-intensity waves are designed to increase cell signaling in blood vessels, which in turn promotes blood flow to nerves and the vaginal lining. The therapy also aims to stimulate the release of growth factors in vaginal tissue, encouraging the formation of new blood vessels, a process known as neovascularization.
Providers who offer FemiWave describe the end result as healthier vaginal tissue with enhanced sensitivity and improved natural lubrication. The treatment is noninvasive, meaning it doesn’t involve surgery, incisions, or anesthesia.
What a Typical Treatment Looks Like
A single FemiWave session lasts about 15 to 20 minutes. The standard recommendation ranges from 6 to 12 sessions, though some clinics advertise a shorter 4-treatment protocol. Sessions are typically spaced out over several weeks.
Providers generally describe the procedure as comfortable, with patients feeling a mild pulsing sensation. There is no standard recovery period, and most clinics market it as a “no downtime” treatment, meaning you can return to normal activities the same day.
Cost and Insurance
FemiWave is not typically covered by insurance. Based on available pricing, a single session costs around $300, putting a full course of treatment (6 to 12 sessions) in the range of $1,800 to $3,600 depending on the provider and location. Some clinics offer package deals that reduce the per-session cost. Prices vary significantly by practice, so it’s worth comparing quotes.
What the Research Actually Shows
The evidence picture for FemiWave specifically is limited. There are no large, peer-reviewed clinical trials published on the FemiWave device by name. The claims made by providers draw largely from research on related energy-based vaginal therapies, including radiofrequency treatments, which use a different type of energy than acoustic waves.
Studies on those related technologies have shown some promising results. One double-blinded, sham-controlled trial found that 50% of women in the active treatment group reported no vaginal laxity at the final follow-up, compared to 12% in the sham (placebo) group. The same study found significant improvements in sexual function scores and patient satisfaction. Another study of radiofrequency treatment after vaginal delivery found that 87% of participants reported improved vaginal tightness at six months, and sexual function scores improved significantly. A separate trial examining energy-based therapy for urinary symptoms and menopausal changes found significant improvements across all eight measured outcomes, and tissue biopsies showed increased density of elastic fibers with no scarring or damage to deeper tissue layers.
These results are encouraging, but they come with important caveats. The studies used radiofrequency devices, not acoustic wave therapy. Extrapolating results from one type of energy-based treatment to another is a leap. The specific mechanism, depth of tissue penetration, and biological response differ between technologies. Until trials are published using the FemiWave device itself, the clinical evidence remains indirect.
FDA Status and Safety Concerns
The regulatory landscape around vaginal rejuvenation devices is worth understanding before committing to treatment. In 2018, the FDA issued a public warning about energy-based devices marketed for vaginal “rejuvenation,” stating that applying energy-based therapies to vaginal tissue may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and chronic pain. The agency noted it had received reports of patients developing severe bladder and urethral pain, bruising, and ongoing discomfort after these types of procedures.
The FDA’s concern was not that every patient would experience harm, but that the devices were being marketed for uses they had not been cleared for, and that patients were not being adequately informed of the risks. Many energy-based devices in this category have FDA clearance for general surgical purposes (like cutting or coagulating tissue) but not specifically for treating sexual dysfunction, vaginal laxity, or menopausal symptoms.
FemiWave’s parent technology does appear in the FDA’s 510(k) database, classified under cardiovascular devices for acoustic wave therapy. However, the specific indications for use in the context of vaginal rejuvenation are not clearly established in public FDA documents. This distinction matters: a device can be legally sold while still lacking FDA clearance for the specific way it’s being marketed to you.
Who Markets FemiWave
FemiWave is offered through a network of private clinics, often alongside GAINSWave, a companion branded acoustic wave treatment marketed to men for erectile dysfunction. Both brands operate under the same umbrella and use a similar provider network model, where individual clinics purchase the equipment and market the service under the brand name. This means your experience can vary depending on the training and expertise of the specific provider.
The treatment is most commonly offered by urologists, gynecologists, and providers at regenerative medicine or sexual wellness clinics. Because the quality and protocols can differ between practices, it’s reasonable to ask a prospective provider about their specific training with the device, the number of procedures they’ve performed, and what outcomes their patients have reported.
Potential Risks
Most providers describe FemiWave as low-risk, and mild discomfort during or after a session appears to be the most commonly reported side effect. However, the FDA’s broader warning about energy-based vaginal devices documented more serious complications across this category of treatments, including burns, chronic pain, and painful intercourse. Patient reports submitted to the FDA have described severe bladder pain developing within days of treatment and persistent bruising.
The absence of large-scale safety data specific to FemiWave makes it difficult to quantify how common these complications are. The mild pulse waves used in acoustic therapy differ from the thermal energy in radiofrequency or laser devices, which may carry different risk profiles. Still, applying any form of directed energy to sensitive tissue carries inherent risk, and the long-term effects of repeated acoustic wave therapy on vaginal tissue have not been studied extensively.