InMode Evolve (Tite/Trim/Tone)
RF body contouring · Hands-free RF + EMS applicators
Technology: EMS & Muscle Stimulation
At a glance
- New-unit reference · older model
- $140k–$180kSource not documented
- Used asking price
- $40k–$80kSource not documented
- FDA status
- Supplies & recurring costs
- Supply details not yet documented.
Sources and verified data on file
Data on file
- Recurring consumables
- Not verified
- Used asking prices
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Figures are reference points, not current offers. Used asking prices are not completed-sale values.
Read FDA-cleared indicationsExact wording from 4 FDA records
K201285 (InMode, Ltd., 2021)
The EVOLVE System with the Tone Applicator is an electro-muscle and transcutaneous nerve stimulation device for the treatment of different body areas. The EVOLVE System with Tone Applicator is designed to operate in two modes – EMS and TENS. In EMS mode it is used for: • Relaxation of muscle spasms • Prevention or retardation of disuse atrophy • Increasing local blood circulation • Muscle re-education • Maintaining or increasing range of motion • Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis. And in TENS mode is intended for: • Symptomatic relief and management of chronic, intractable pain • Post-surgical acute pain • Post-trauma acute pain
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K210877 (InMode, Ltd., 2021)
The Evolve System with the T3 Applicator employs RF technology or EMS-TENS technology for the treatment of selected medical conditions. The T3 Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. The T3 Applicator in EMS mode is intended for: • Relaxation of muscle spasms • Prevention or retardation of disuse atrophy • Increasing local blood circulation • Muscle re-education
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K231495 (InMode, Ltd., 2023)
The Evolve System with the Transform Applicator employs RF technology and EMS-TENS technology for the treatment of selected medical conditions. The Transform Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. The Transform Applicator in EMS mode is intended for: • Relaxation of muscle spasms • Prevention or retardation of disuse atrophy • Increasing local blood circulation • Muscle re-education • Maintaining or increasing range of motion • Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis. The Transform Applicator in TENS mode is intended for: • Symptomatic relief and management of chronic, intractable pain • Post-surgical acute pain • Post-trauma acute pain. Additionally the Transform Applicator in sequential RF/EMS mode is intended for: • Non-invasive lipolysis (breakdown of fat) of the abdomen • Reduction in circumference of the abdomen
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K221571 (InMode, Ltd., 2022)
The InMode Multi System with the Diode laser Applicators is indicated for: • Diolaze XL 810nm Applicator is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime. • Diolaze XL 755/810nm & 810/1064nm Applicators are intended for hair removal. • VLaze Applicator is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions. The InMode Multi System with the IPL Applicator is indicated for: • IPL Applicator with wavelengths (515-1200nm) is indicated for use for the following treatments: The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles); The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikilodenna of Civatte, superficial leg veins and venlous malformations. The InMode Multi System with the non-invasive RF Applicators is indicated for: • BodyFX (WMBody) and MiniFX Applicators are intended for the treatment of the following medical conditions: Relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation; and temporary reduction in the appearance of cellulite. • PLUS/ PLUS90/PLUS-PLUS (FORMA) and i-Forma Applicators are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. • FaceFX (WMFace) Applicator is intended for use in dermatologic procedures, for noninvasive treatment of mild to moderate facial wrinkles and rhytids. The InMode Multi System with the Fractional RF Applicators is indicated for: • FRACTORA 60 pin Applicator is intended for use in dermatological procedures requiring ablation and resurfacing of the skin. • FRF 24 pin Applicator is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. • Fractora3D and Morpheus8 Applicators are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62 mJ/pin, use is limited to Skin Types I-IV.
Verbatim from the FDA 510(k) summary, retrieved 18 Sep 2026.
Page updated: September 18, 2026 · How we verify
Axis runs $0–$180k. Reference figures, not current offers. Used asking prices are not completed-sale values.
Not verified
We hold no per-treatment consumable price for this device from a dated source. Ask the seller for a written per-treatment cost.
Price sourcesSources, dates and configurations
Key factsCompany, specifications and verification dates
| Manufacturer | InMode |
|---|---|
| Company | Owner: Publicly traded (NASDAQ: INMD; no single controlling owner) (public company, since 2019) · Distribution: direct |
| Parent company | InMode |
| Brand owner | InMode |
| Built by (OEM) | InMode Ltd. |
| Category | Body Contouring |
| Technology | Hands-free RF + EMS applicators |
| FDA status | FDA Cleared |
| 510(k) citation | K201285, K210877, K231495, K221571 |
| New-unit reference (older model) | $140k–$180k |
| Used asking range | $40k–$80k |
| Consumables | Not published |
| Launch year | 2019 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
First hands-free InMode body suite
FDA & regulatory detailClearance timeline, authorization route and citation notes
FDA-cleared indications (verbatim)
K201285 (InMode, Ltd., 2021)
The EVOLVE System with the Tone Applicator is an electro-muscle and transcutaneous nerve stimulation device for the treatment of different body areas. The EVOLVE System with Tone Applicator is designed to operate in two modes – EMS and TENS. In EMS mode it is used for: • Relaxation of muscle spasms • Prevention or retardation of disuse atrophy • Increasing local blood circulation • Muscle re-education • Maintaining or increasing range of motion • Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis. And in TENS mode is intended for: • Symptomatic relief and management of chronic, intractable pain • Post-surgical acute pain • Post-trauma acute pain
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K210877 (InMode, Ltd., 2021)
The Evolve System with the T3 Applicator employs RF technology or EMS-TENS technology for the treatment of selected medical conditions. The T3 Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. The T3 Applicator in EMS mode is intended for: • Relaxation of muscle spasms • Prevention or retardation of disuse atrophy • Increasing local blood circulation • Muscle re-education
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K231495 (InMode, Ltd., 2023)
The Evolve System with the Transform Applicator employs RF technology and EMS-TENS technology for the treatment of selected medical conditions. The Transform Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. The Transform Applicator in EMS mode is intended for: • Relaxation of muscle spasms • Prevention or retardation of disuse atrophy • Increasing local blood circulation • Muscle re-education • Maintaining or increasing range of motion • Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis. The Transform Applicator in TENS mode is intended for: • Symptomatic relief and management of chronic, intractable pain • Post-surgical acute pain • Post-trauma acute pain. Additionally the Transform Applicator in sequential RF/EMS mode is intended for: • Non-invasive lipolysis (breakdown of fat) of the abdomen • Reduction in circumference of the abdomen
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K221571 (InMode, Ltd., 2022)
The InMode Multi System with the Diode laser Applicators is indicated for: • Diolaze XL 810nm Applicator is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime. • Diolaze XL 755/810nm & 810/1064nm Applicators are intended for hair removal. • VLaze Applicator is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions. The InMode Multi System with the IPL Applicator is indicated for: • IPL Applicator with wavelengths (515-1200nm) is indicated for use for the following treatments: The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles); The treatment of benign cutaneous vascular lesions, including port wine stains, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikilodenna of Civatte, superficial leg veins and venlous malformations. The InMode Multi System with the non-invasive RF Applicators is indicated for: • BodyFX (WMBody) and MiniFX Applicators are intended for the treatment of the following medical conditions: Relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation; and temporary reduction in the appearance of cellulite. • PLUS/ PLUS90/PLUS-PLUS (FORMA) and i-Forma Applicators are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. • FaceFX (WMFace) Applicator is intended for use in dermatologic procedures, for noninvasive treatment of mild to moderate facial wrinkles and rhytids. The InMode Multi System with the Fractional RF Applicators is indicated for: • FRACTORA 60 pin Applicator is intended for use in dermatological procedures requiring ablation and resurfacing of the skin. • FRF 24 pin Applicator is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. • Fractora3D and Morpheus8 Applicators are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62 mJ/pin, use is limited to Skin Types I-IV.
Verbatim from the FDA 510(k) summary, retrieved 18 Sep 2026.
Marketed for
EMS / muscle stimulation — Hands-free RF + EMS applicators
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Parent company: InMode
Legal manufacturer: InMode Ltd. (Israel)
Applicant on the FDA record
InMode, Ltd.The applicant named on the FDA record can differ from the brand shown on the device.
Regulatory data comes from public FDA records and may lag recent updates. Confirm the applicable status and documentation before purchase.
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Listed manufacturer for this profile: InMode Ltd.
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Treatment & running costs
Treatments
Sessions & timing
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Supplies & recurring costs
Consumable costs are not documented yet.
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History2 tracked changes
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September 18, 2026
fda ifu
September 18, 2026: Astra visually transcribed the Indications for Use block from FDA PDF page 3. Original wording retained, including source spelling; line wrapping/bullet glyphs normalized. Replaces incomplete text (K221571) or summary wording with the indication-form wording (K260691). Model-to-clearance associations were not reclassified by this transcription check.
Source: https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221571.pdf
August 1, 2026
Record created
Added to The Aesthetic Index — August 2026
Source: The Aesthetic Index editorial
Cite this data: The Aesthetic Index, "InMode Evolve (Tite/Trim/Tone) — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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