Best Pelvic Floor and Women's Health Devices for Med Spas (2026): Emsella and 4 More Compared

For med spa owners, medical directors and women's health clinics. Updated October 22, 2026 · Prepared by Prospyr. Prospyr makes practice software, not medical devices, and none of the companies below is a Prospyr product or partner. This guide covers BTL's EMSELLA chair and four other pelvic floor and women's wellness devices sold to practices. Each summary reflects what the company publishes on its own website, checked October 2026, and each FDA-cleared indication is quoted from the FDA's 510(k) database, linked next to the claim. This article is not medical advice and makes no claim about the safety, effectiveness or results of any device. Confirm the current clearance, labeling and terms in writing before you buy.

What is EMSELLA, and what are pelvic floor devices cleared to do?

EMSELLA is BTL's chair-style device that uses electromagnetic energy to stimulate the pelvic floor muscles while the patient sits clothed, and the FDA has cleared BTL's chair device for the treatment of urinary incontinence. Several companies now sell similar devices to practices. Pelvic floor stimulators like EMSELLA are cleared under the FDA product code KPI, "Stimulator, Electrical, Non-Implantable, For Incontinence," and each one's cleared indication names urinary incontinence in women, or in men and women. Laser and radiofrequency devices sold for women's health are a different group: their clearances cover general surgical or dermatology uses, not vaginal "rejuvenation." The table and entries below quote each cleared indication as the FDA lists it.

A note on the FDA's 2018 safety communication

On July 30, 2018, the FDA issued a safety communication, "FDA Warns Against Use of Energy-Based Devices to Perform Vaginal 'Rejuvenation' or Vaginal Cosmetic Procedures" (archived FDA copy; the page no longer loads on fda.gov as of October 2026). It covered energy-based devices, commonly radiofrequency or laser, cleared for general gynecologic uses. The FDA stated that it had "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," and that such use "may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring/chronic pain." If you offer any device in this category, keep your website, social posts and consult scripts inside the cleared indication, and have them reviewed. See our list of medical advertising compliance reviewers.

The 5 women's health devices at a glance

How we chose this list

We started from the FDA's 510(k) database and kept devices that (1) hold a 510(k) clearance we could find and read, (2) are marketed to US practices for pelvic floor or women's health on the company's own website as of October 2026, and (3) are sold for use in a clinic, not as a home device. For each device we quote the cleared indication from the FDA record and nothing more. Where a company's website describes uses beyond that indication, we say so plainly rather than repeat those uses. The order is our editorial view, starting with the chair devices cleared specifically for urinary incontinence. It is not a ranking of results.

1BTL Industries (EMSELLA)#

BTL Industries markets EMSELLA, a chair that delivers electromagnetic stimulation to the pelvic floor while the patient sits clothed. BTL's EMSELLA page describes it "for the treatment of male and female urinary incontinence." The FDA database lists BTL's chair device as HPM-6000U, cleared in 2016 "for the treatment of urinary incontinence in women" (K162010), then HPM-6000UF, cleared in 2018 with the indication expanded to "male and female urinary incontinence" (K181497).

What stands out:

• Longest clearance history here. BTL's 2016 clearance is the earliest of the chair clearances on this list, and later chairs from other companies were cleared with similar indication wording.
• Newer clearance. In September 2026 the FDA cleared BTL-299-F (K262353), which the 510(k) summary describes as identical in design to HPM-6000UF, with the indication expanded to add "the treatment of fecal incontinence in male and female patients."
• Patient-facing locator. BTL's consumer site has a "Find a Provider" search that lists practices offering its treatments.

Right for: practices that want the pelvic floor chair most patients already know by name. Ask: which clearance covers the units BTL ships today, what the provider listing requires, and the full purchase or lease terms in writing.

Visit BTL Industries (EMSELLA) →

2InMode (EmpowerRF with vTone)#

InMode sells EmpowerRF, a women's wellness platform that its site says combines several technologies, including VTone, FormaV and Morpheus8. InMode calls VTone "a gentle, FDA cleared technology designed to provide intravaginal electrical muscle stimulation." The FDA database lists the InMode System with vTone Applicator, cleared in 2020, "to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women" (K200293).

What stands out:

• One platform, several applicators. EmpowerRF groups VTone with other InMode applicators, so one console serves more than one service line.
• Only VTone is described as cleared on the page. InMode's EmpowerRF page makes an FDA clearance statement for VTone only. It does not cite a clearance for FormaV or Morpheus8V on that page.
• Disclaimer. The page notes that "approved intended use varies by country."

Right for: practices that already own InMode equipment or want one platform for several services. Ask: the 510(k) number and cleared indication for every applicator you plan to use, and which ones are included in the price.

Visit InMode (EmpowerRF with vTone) →

3Fotona (StarFormer)#

Fotona, a laser company, sells the StarFormer, a chair with applicators in the seat and backrest; its US site markets pelvic floor use under the IntimaWave name. The FDA database lists Fotona StarFormer, cleared in July 2024, "to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in women" (K234061).

What stands out:

• Pro model. Fotona's US site describes the StarFormer Pro with two integrated chair applicators plus handheld applicators, and offers a free demo.
• Laser portfolio. Practices that already use Fotona lasers can buy from the same company.
• Women only in the clearance. The cleared indication names urinary incontinence in women. Fotona's site lists other conditions; keep your marketing to the cleared indication.

Right for: practices that already work with Fotona or want a chair with extra applicators. Ask: which of the listed uses are covered by the US clearance, and what training is included.

Visit Fotona (StarFormer) →

4Zimmer MedizinSystems (PF Toner Pro)#

Zimmer MedizinSystems, a physical medicine and aesthetics manufacturer, sells the PF Toner Pro through its US aesthetic division. Its page describes "passive pelvic floor muscle training with electromagnetic field energy" for "the treatment of female and male urinary incontinence." The page does not cite a 510(k) number. The FDA database lists Zimmer Medizinsysteme GmbH's MFG-05, cleared in October 2023, for "non-invasive electromagnetic stimulation of the pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence" (K230780).

What stands out:

• Physical medicine background. Zimmer's US site also lists physical medicine equipment and other aesthetic lines, including Z Cryo and Z Wave.
• US contact published. The page lists a US phone number and email for sales questions.

Right for: practices and wellness clinics that also offer physical therapy or want a second-source chair. Ask: Zimmer to confirm in writing that PF Toner Pro is the device cleared under K230780, and for the full purchase and service terms.

Visit Zimmer MedizinSystems (PF Toner Pro) →

5Alma Lasers (FemiLift)#

Alma Lasers sells FemiLift, which its site describes as "a state-of-the-art, minimally-invasive outpatient gynecological solution" using Pixel CO2 technology. The FDA database lists the Alma FemiLift Pixel CO2 Laser System, cleared in September 2025, for "surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue" in specialties including dermatology and plastic surgery and gynecology, with specific gynecology procedures such as conization of the cervix and treatment of condyloma listed in the indication (K250071).

What stands out:

• A surgical laser, not a chair. FemiLift is a CO2 laser with a general surgical clearance, so it sits in the device group the FDA's 2018 communication addressed.
• Marketing differs from the clearance. Alma's FemiLift page lists genitourinary syndrome of menopause, vulvovaginal atrophy and stress urinary incontinence as treatment categories. Those conditions are not named in the cleared indication.

Right for: practices with gynecology physicians who already perform the cleared procedures. Ask: for the full indications for use and labeling, and have your compliance reviewer approve any patient marketing before launch.

Visit Alma Lasers (FemiLift) →

Not on this list

We left out devices we could not confirm for US practices in October 2026: Viveve (we could not confirm the company is still operating), Sciton's diVa (Sciton's site presents diVa on its international pages), and newer chair clearances such as PELVIPOWER (K252334, April 2026) where we could not find a US sales channel. We will look again at the next quarterly review.

Questions to ask any women's health device company

1. What is the 510(k) number and the exact cleared indication? Look it up yourself in the FDA 510(k) database and keep a copy of the indications for use page.
2. Does every applicator have its own clearance? Platforms often combine several handpieces. Get the number for each one you plan to use.
3. Does your marketing match the clearance? Compare the company's patient brochures with the cleared indication, and read the FDA's 2018 communication above before you launch.
4. Who may operate the device in your state? Delegation and supervision rules vary. Confirm with your medical director and state board.
5. What does a session cost you? Ask about disposables, service contracts, software fees and warranty length.
6. Is it bought outright, leased or financed? Get the full payment schedule. Run the numbers with our equipment ROI calculator and lease vs. buy calculator, or see our list of aesthetic equipment financing companies.
7. How do we report an adverse event? Know the manufacturer's contact and the FDA MedWatch route.

Where Prospyr fits

Pelvic floor treatments usually run as a series of visits, so the work is in booking, charting and follow-up. Prospyr lets a practice sell a series through packages or memberships, book every visit with online scheduling, and keep consent and treatment notes in the aesthetic EMR on one patient record. For other equipment, see our lists of wellness equipment for clinics and body contouring machines, or book a practice demo.

Frequently asked questions

Is EMSELLA FDA cleared?

Yes. The FDA database lists BTL's chair device, HPM-6000U, as cleared in 2016 for urinary incontinence in women (K162010), and HPM-6000UF as cleared in 2018 for male and female urinary incontinence (K181497). Clearance means the FDA found the device substantially equivalent to an existing device; it is not FDA approval.

What is the difference between a pelvic floor chair and a vaginal laser or RF device?

Pelvic floor chairs on this list are cleared as non-implantable stimulators for urinary incontinence. Laser and radiofrequency devices sold for women's health hold general surgical or dermatology clearances. In 2018 the FDA said it had not cleared any energy-based device to treat symptoms related to menopause, urinary incontinence or sexual function.

Can a med spa offer EMSELLA or similar devices?

That depends on your state's rules on who may operate the device, your medical director's protocols and the device's prescription labeling. The 510(k) summary for BTL's HPM-6000UF describes it as prescription use only. Check with your medical director and state board before you add the service.

How much does an EMSELLA chair cost?

None of the five companies on this list publishes a device price. Ask each for the device price, service contract and warranty together, and compare purchase against lease.

Want your company considered?

We review this list quarterly. Companies that make or distribute FDA-cleared pelvic floor or women's health devices for practices can send their website, 510(k) numbers and what they offer practices to info@prospyrmed.com. Inclusion is editorial and not paid.

Editorial scope

This list is based on each company's public website and the FDA's 510(k) database, checked October 2026 with AI-assisted research. Companies did not review this article before publication. It is not medical advice, a comparison of device safety or results, or a substitute for each device's FDA-cleared labeling and your state's scope-of-practice rules. Read our methodology or report a correction.