InMode EmpowerRF (Morpheus8V)

RF Microneedling · Intravaginal + facial RF microneedling platform

CurrentFDA ClearedBe the first to review

What it's actually cleared for: Be precise. VTone is cleared under K200293 (2020) for electrical stimulation and neuromuscular re-education to rehabilitate weak pelvic floor muscles for stress, urge, and mixed urinary incontinence in women — the only applicator with an incontinence indication. Morpheus8 applicators (K192695 and successors) are cleared for electrocoagulation and hemostasis in dermatologic and general surgical procedures — Morpheus8V carries surgical-tool language, not a rejuvenation or sexual-function indication. FormaV descends from circulation/muscle-relief clearances; in July 2018 FDA sent InMode an "It Has Come to Our Attention" letter over FormaV/FractoraV marketing for sexual dysfunction, rejuvenation, and incontinence — market strictly within cleared language.

Last verified: August 6, 2026 · How we verify

New: $90k–$150k|Used: $50k–$80kmarket estimate, no email required

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Bottom line

The most complete women's-intimate-wellness platform on the market and, run correctly inside an OB/GYN, urogyn, or physician-led medspa, a genuine cash-pay profit center with almost no local competition. The catch is regulatory: this is the exact category where FDA publicly cracked down on "vaginal rejuvenation" marketing in 2018 — and InMode itself received an FDA letter — so your website copy matters as much as your protocol. Real per-treatment tip costs, unlike most InMode gear. Buy it only with clinicians credible in pelvic health; a lash-and-Botox spa should not own this.

Overview

Women's-health platform sharing Morpheus8 tech

How it works

The science

Three applicator families: Morpheus8V — fractional RF microneedling adapted for vaginal/vulvar tissue, coagulating and remodeling mucosal/submucosal tissue at depth. FormaV — non-ablative bipolar RF bulk heating of the vaginal canal and vulva with temperature feedback, aimed at circulation and laxity. VTone — intravaginal EMS contracting and re-educating the pelvic floor for stress, urge, and mixed urinary incontinence. Together: tissue quality, laxity, and muscle function — the legitimate clinical trio behind the marketing gloss.

Patented tech

Morpheus8's Burst mode (multi-depth RF per insertion) carries to the V applicator; FormaV's ACE is thermistor cut-off control. The platform's edge is integration, not any single mechanism.

Origin

Yokneam, Israel (InMode).

FDA & regulatory status

FDA ClearedCleared via 510(k)

What it's actually cleared for:

Be precise. VTone is cleared under K200293 (2020) for electrical stimulation and neuromuscular re-education to rehabilitate weak pelvic floor muscles for stress, urge, and mixed urinary incontinence in women — the only applicator with an incontinence indication. Morpheus8 applicators (K192695 and successors) are cleared for electrocoagulation and hemostasis in dermatologic and general surgical procedures — Morpheus8V carries surgical-tool language, not a rejuvenation or sexual-function indication. FormaV descends from circulation/muscle-relief clearances; in July 2018 FDA sent InMode an "It Has Come to Our Attention" letter over FormaV/FractoraV marketing for sexual dysfunction, rejuvenation, and incontinence — market strictly within cleared language.

510(k) numbers

K192695; K240017

Regulatory data is compiled from public FDA 510(k) records and may lag recent clearances. Always confirm status with the manufacturer before purchase.

Treatment economics

What practices charge

Morpheus8V $1,000-1,800/session, series of 3; FormaV $500-900, series of 3; VTone $200-400 in courses of 6. Bundled programs $3,000-6,000; incontinence-driven patients convert at high rates because the alternative is surgery or pads.

Consumables & recurring cost

Single-use tips on all three applicators — ~$100-200 per Morpheus8V tip, smaller for FormaV/VTone disposables (verify current pricing). 20 treatments/month ≈ $15k-30k/year — modest against revenue but not zero like Emsella.

Ideal for

Best-fit practice

OB/GYN and urogynecology practices adding cash-pay services; physician-owned medspas with an NP/MD who can own the pelvic-health consult. Patients 35-70: postpartum laxity, menopausal GSM symptoms, stress incontinence — an underserved, high-loyalty population.

Compliance

Medical director & delegation

Demands more than a rubber-stamp director — intravaginal RF and microneedling are invasive procedures most states restrict to physicians, NPs/PAs, or closely-delegated RNs, and the 2018 FDA history makes women's-health RF a plaintiff-attorney magnet. Get a director who reviews protocols and marketing copy.

Contraindications & screening

Pregnancy, IUD in situ (protocol-dependent — verify), active pelvic infection or undiagnosed bleeding, pelvic mesh/implanted electronics, prolapse beyond mild grades, pending abnormal Pap workup.

Ownership

Warranty & service

1-year standard with extended sold at close; applicator cables and intravaginal handpieces see real wear — inspect used units carefully.

Resale & used market

Thinner and slower than Optimas/Morpheus8 — the buyer pool willing to do intimate wellness is smaller; used at ~$90k-140k against ~$200k list. Longer sale timelines but decent value retention within the niche.