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InMode Envision

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IPL multi-app platform

Classification & configurations

Category group: Hair removal (diode, alexandrite, Nd:YAG, IPL)

Current

At a glance

New price
Not published
FDA status
Supplies & recurring costs
Supply details not yet documented.
View supply details
Sources and verified data on file

Data on file

Recurring consumables
Not verified
FDA
FDA ClearedK221571, K210492, K200293
Used asking prices
Not verified
  • This panel shows a per-treatment supply cost only when a recorded figure has a dated source.
  • Bottle prices and estimates may still appear under Treatment & running costs.
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Figures are reference points, not current offers.

Read FDA-cleared indicationsExact wording from 3 FDA records

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.

K210492 (InMode MD, Ltd., 2021)

The InMode RF Pro System with the Non-invasive Applicators employs RF energy for various applications: • i-Forma, Forma (Plus), Plus (Plus Plus) and Plus90 for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation. • WMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids. • BodyFX™ (WMBody)/MiniFX™ for Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite. The InMode RF Pro System with the Fractional Applicators employs RF energy for various applications: • Fractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacing of the skin. • Fractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV • Morpheus8™ for dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV

Verbatim from the FDA 510(k) summary, retrieved 18 Sep 2026.

K200293 (InMode, Ltd., 2020)

The InMode System with the vTone Applicator is intended 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.

Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.

Page updated: September 21, 2026 · How we verify

No new-equipment price range is published for this model. Ask the seller for a dated, itemized quote covering configuration, training and service.

Price sourcesSources, dates and configurations

No price sources are documented yet. Ask the seller for a current, itemized quote.

Key factsCompany, specifications and verification dates
Key facts
ManufacturerInMode
CompanyOwner: Publicly traded (NASDAQ: INMD; no single controlling owner) (public company, since 2019) · Distribution: direct
Parent companyNot published
Brand ownerInMode
CategoryIPL multi-app platform
TechnologyNot published
FDA statusFDA Cleared
510(k) citationK221571, K210492, K200293
New price rangeNot published
Used asking rangeNot published
ConsumablesNot published
Launch yearNot published
PricingNot published
Manufacturer-source documents checkedNot published

Overview

A multi-application platform. Its own AccessGUDID record (device identifier 07290016633726, labeler INMODE M.D LTD) describes it as carrying the Forma-I, Forma, Morpheus8 and Lumecca applicators, using intense pulsed light and radiofrequency.

No outcome claim is made here.

FDA & regulatory detailClearance timeline, authorization route and citation notes
Authorized via 510(k)

AccessGUDID identifies Envision System, model AG609993A (DI 07290016633726), and lists K221571, K210492 and K200293. The FDA decisions name InMode Multi-system, InMode RF Pro System and InMode System with vTone Applicator, respectively. The registry describes Forma-I, Forma, Morpheus8 and Lumecca applicators; each applicator has its own scope. K200293 concerns pelvic-floor stimulation with vTone and does not establish an ocular indication. The registration link does not mean every indication in all three records applies to every Envision configuration. Model linkage and decision records checked September 18, 2026.

FDA-cleared indications (verbatim)

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.

K210492 (InMode MD, Ltd., 2021)

The InMode RF Pro System with the Non-invasive Applicators employs RF energy for various applications: • i-Forma, Forma (Plus), Plus (Plus Plus) and Plus90 for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation. • WMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids. • BodyFX™ (WMBody)/MiniFX™ for Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite. The InMode RF Pro System with the Fractional Applicators employs RF energy for various applications: • Fractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacing of the skin. • Fractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV • Morpheus8™ for dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV

Verbatim from the FDA 510(k) summary, retrieved 18 Sep 2026.

K200293 (InMode, Ltd., 2020)

The InMode System with the vTone Applicator is intended 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.

Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.

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.

Treatment & running costs

Treatments

Sessions & timing

No treatment schedule documented yet.

What practices charge

No sourced treatment price on file.

Supplies & recurring costs

Consumable costs are not documented yet.

Annual service & support

No annual service cost documented yet.

Warranty & serviceWhat to confirm in writing before you buy

Before buying new or used, confirm in writing:

  • Current warranty coverage
  • Included training
  • Service terms

Chains using this device

A chain listing does not establish availability at every location.

No confirmed chain deployments recorded yet.

Owner & operator reviews

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Current alternatives

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History7 tracked changes

Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.

  1. September 21, 2026

    Availability status

    Current

    Source: Catalog update

  2. September 21, 2026

    Lifecycle status

    Current

    Filled the missing catalog status from InMode’s current Envision professional product and inquiry page. Model identity, applicators, FDA information, prices and reviews are unchanged. Current is not a stock or configuration guarantee.

    Source: https://offer.inmodemd.com/envision

  3. September 18, 2026

    fda ifu

    September 18, 2026: Astra visually checked FDA PDF page 3 (Indications for Use, page 1 of 1). Complete indication block transcribed; source wording and restrictions retained, line wrapping normalized. Added the missing record already cited by Envision; model/clearance associations unchanged.

    Source: https://www.accessdata.fda.gov/cdrh_docs/pdf21/K210492.pdf

  4. September 18, 2026

    fda scope note

    Official UDI model link reconciled with all three FDA decision records; status and identifiers unchanged. No complete IFU or clinical-efficacy certification.

    Source: https://accessgudid.nlm.nih.gov/devices/07290016633726

  5. September 18, 2026

    fda search completed on

    2026-09-18

    Model-to-record search completed; missing K210492 verbatim indications still require separate extraction.

    Source: https://accessgudid.nlm.nih.gov/devices/07290016633726

  6. 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

  7. September 18, 2026

    Company profile link

    Not linkedInMode

    Linked existing Envision catalog entry to its existing company record using the official product page. Claim status remains unclaimed.

    Source: https://offer.inmodemd.com/envision

Cite this data: The Aesthetic Index, "InMode Envision — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).

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