BTL Aesthetics Exion
RF body contouring · Monopolar RF + targeted ultrasound (body applicator)
Technology: HIFU & Ultrasound
Classification & configurations
Also sold as / variants: Exion (full platform) — applicator and configuration variants of the same platform, covered on this page.
At a glance
- New price
- $150k–$200kReported source: Dealer quote · Aug 12, 2026
- FDA status
- Supplies & recurring costs
- See supply and replacement costs below.
Sources and verified data on file
Data on file
- Recurring consumables
- Not verified
- 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.
- The calculator may include a labeled planning estimate. Review it or enter your own allowance; missing data never means $0.
Figures are reference points, not current offers.
Latest price source dated: Aug 12, 2026
·FDA database · Updated Aug 12, 2026Read FDA-cleared indicationsExact wording from 3 FDA records
K211639 (BTL Industries, Inc., 2022)
The BTL-785W device has the following indications for use: The BTL-785W with BTL-785-1 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite. The BTL-785W with BTL-785-2 applicator is indicated to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785W with BTL-785-3 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785W with BTL-785-4 applicator used with tips BTL-785-4-1, BTL-785-4-2, BTL-785-4-5 and BTL-785-4-6 is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The Applicator BTL-785-4 of BTL-785W device used with tips BTL-785-4-3, BTL-785-4-4, BTL-785-4-7 and BTL-785-4-8 is intended for dermatological procedures requiring fractional treatment of the skin. At higher energy levels greater than 62 mJ/pin, use of the BTL-785-4 applicator is limited to Skin Types IIV. The BTL-785W with BTL-785-7 hands-free applicator used with BTL-785-7-1, BTL-785-7-2, BTL-785- 7-3, BTL-785-7-4, BTL-785-7-5 and BTL-785-7-6 single-use electrodes is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K222556 (BTL Industries, Inc., 2023)
The BTL-785X device has the following indications for use: The BTL-785X with BTL-785-1 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite. The BTL-785X with BTL-785-2 applicator is indicated to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785X with BTL-785-3 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785X with BTL-785-4 applicator used with tips BTL-785-4-1, BTL-785-4-2, BTL-785-4-5 and BTL-785-4-6 is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The Applicator BTL-785-4 of BTL-785X device used with tips BTL-785-4-3, BTL-785-4-4, BTL-785-4-7 and BTL-785-4-8 is intended for dermatological procedures requiring fractional treatment of the skin. At higher energy levels greater than 62 mJ/pin, use of the BTL-785-4 applicator is limited to Skin Types I-IV. The BTL-785X with BTL-785-7 hands-free applicator used with forehead BTL-785-7-1 and cheek BTL-785-7-2 single-use electrodes is intended to provide: • heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. • non-invasive temporary reduction of facial wrinkles
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K233604 (BTL Industries, Inc., 2024)
The BTL-785S device has the following indications for use: The BTL-785S with BTL-785-1 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite. The BTL-785S with BTL-785-2 applicator is indicated to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785S with BTL-785-3 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785S with BTL-785-4 applicator used with tips BTL-785-4-1, BTL-785-4-2, BTL-785-4-5 and BTL-785-4-6 is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The Applicator BTL-785-4 of BTL-785S device used with tips BTL-785-4-3, BTL-785-4-4, BTL-785-4-7 and BTL-785-4-8 is intended for dermatological procedures requiring fractional treatment of the skin. At higher energy levels greater than 62 mJ/pin, use of the BTL-785-4 applicator is limited to Skin Types I-IV. The BTL-785S with BTL-785-7 Handpiece used with hands-free applicators: BTL-785-7-1 & BTL-785-7-7, BTL-785-7-2 & BTL-785-7-8 single-use applicators are intended to provide: - Heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. BTL-785-7-1 & BTL-785-7-2 single-use applicators are intended to provide: - Non-invasive temporary reduction of facial wrinkles. BTL-785-7-9 single-use applicator is intended to: - Affect the appearance of lax tissue in the submental area.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: September 8, 2026 · How we verify
Axis runs $0–$200k. Reference figures, not current offers.
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 | BTL Aesthetics |
|---|---|
| Company | Owner: BTL Group; founder-controlled (private) (family / founder owned, since 1993) · Distribution: direct |
| Parent company | BTL Aesthetics |
| Brand owner | BTL Aesthetics |
| Built by (OEM) | BTL Industries |
| Category | Body Contouring |
| Technology | Monopolar RF + targeted ultrasound (body applicator) |
| FDA status | FDA Cleared |
| 510(k) citation | K211639, K222556, K233604 |
| New price range | $150k–$200k |
| Used asking range | Not published |
| Consumables | Not published |
| Launch year | 2023 |
| Latest price source dated | Aug 12, 2026 |
| Manufacturer-source documents checked | Not published |
Overview
Newest BTL multi-applicator platform
How it worksTechnology and manufacturing
How the technology works
Four applicators: Exion Face pairs monopolar RF with synchronized non-focused ultrasound for facial/submental skin, claimed to stimulate fibroblasts deeper without needles; Exion Body delivers larger-field RF bulk heating for laxity and cellulite-appearance; Exion Fractional RF is a needle-based fractional handpiece (6x6 electrode array, adjustable depth) doing classic RF microneedling; a hands-free applicator adds RF heating with electromagnetic muscle stimulation.
Net effect: thermal collagen/elastin remodeling. BTL's "224% elastin / 100%+ hyaluronic acid increase" figures come from small company-sponsored histology — directionally plausible, precisely unverifiable.
Expect 4-session courses per area, results building over 8-12 weeks.
Patented technology
The Face applicator's simultaneous RF + ultrasound is branded "Extracellular Matrix stimulation with AI energy flow control" — the AI is an impedance-based auto-adjustment algorithm, not machine learning in any meaningful sense.
The Fractional handpiece's "single-pulse energy flow" is a refinement of standard insulated RF needle delivery.
Origin
Czech Republic (BTL Industries); US entity in Marlborough, MA.
FDA & regulatory detailClearance timeline, authorization route and citation notes
Source and verification notes
·FDA database · Updated Aug 12, 2026Clearance K211639; K242532Platform clearance: K211639 (BTL-785W, decision 7 Mar 2022) covers the BTL-785-1 and BTL-785-2 radiofrequency applicators with ultrasonic tip pre-heating and the BTL-785-7 hands-free applicator; family clearances K222556 (BTL-785X, 31 May 2023) and K233604 (BTL-785S, 28 Mar 2024). FDA names the device by model number, not 'Exion'. K242532 (BTL-785BNF-E, the BTL-785-7 electrostimulation handpiece for facial, neck or body skin stimulation) was removed from this record on 8 Sep 2026 and stays on the EmFace record. Checked 8 Sep 2026.
FDA-cleared indications (verbatim)
K211639 (BTL Industries, Inc., 2022)
The BTL-785W device has the following indications for use: The BTL-785W with BTL-785-1 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite. The BTL-785W with BTL-785-2 applicator is indicated to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785W with BTL-785-3 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785W with BTL-785-4 applicator used with tips BTL-785-4-1, BTL-785-4-2, BTL-785-4-5 and BTL-785-4-6 is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The Applicator BTL-785-4 of BTL-785W device used with tips BTL-785-4-3, BTL-785-4-4, BTL-785-4-7 and BTL-785-4-8 is intended for dermatological procedures requiring fractional treatment of the skin. At higher energy levels greater than 62 mJ/pin, use of the BTL-785-4 applicator is limited to Skin Types IIV. The BTL-785W with BTL-785-7 hands-free applicator used with BTL-785-7-1, BTL-785-7-2, BTL-785- 7-3, BTL-785-7-4, BTL-785-7-5 and BTL-785-7-6 single-use electrodes is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K222556 (BTL Industries, Inc., 2023)
The BTL-785X device has the following indications for use: The BTL-785X with BTL-785-1 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite. The BTL-785X with BTL-785-2 applicator is indicated to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785X with BTL-785-3 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785X with BTL-785-4 applicator used with tips BTL-785-4-1, BTL-785-4-2, BTL-785-4-5 and BTL-785-4-6 is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The Applicator BTL-785-4 of BTL-785X device used with tips BTL-785-4-3, BTL-785-4-4, BTL-785-4-7 and BTL-785-4-8 is intended for dermatological procedures requiring fractional treatment of the skin. At higher energy levels greater than 62 mJ/pin, use of the BTL-785-4 applicator is limited to Skin Types I-IV. The BTL-785X with BTL-785-7 hands-free applicator used with forehead BTL-785-7-1 and cheek BTL-785-7-2 single-use electrodes is intended to provide: • heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. • non-invasive temporary reduction of facial wrinkles
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K233604 (BTL Industries, Inc., 2024)
The BTL-785S device has the following indications for use: The BTL-785S with BTL-785-1 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite. The BTL-785S with BTL-785-2 applicator is indicated to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785S with BTL-785-3 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785S with BTL-785-4 applicator used with tips BTL-785-4-1, BTL-785-4-2, BTL-785-4-5 and BTL-785-4-6 is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The Applicator BTL-785-4 of BTL-785S device used with tips BTL-785-4-3, BTL-785-4-4, BTL-785-4-7 and BTL-785-4-8 is intended for dermatological procedures requiring fractional treatment of the skin. At higher energy levels greater than 62 mJ/pin, use of the BTL-785-4 applicator is limited to Skin Types I-IV. The BTL-785S with BTL-785-7 Handpiece used with hands-free applicators: BTL-785-7-1 & BTL-785-7-7, BTL-785-7-2 & BTL-785-7-8 single-use applicators are intended to provide: - Heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. BTL-785-7-1 & BTL-785-7-2 single-use applicators are intended to provide: - Non-invasive temporary reduction of facial wrinkles. BTL-785-7-9 single-use applicator is intended to: - Affect the appearance of lax tissue in the submental area.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
HIFU / Ultrasound — Monopolar RF + targeted ultrasound (body applicator)
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Parent company: BTL Aesthetics
Legal manufacturer: BTL Industries (Bulgaria)
Applicant on the FDA record
BTL Industries, Inc.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.
Look-alike devices
Comparing an unbranded HIFU (focused ultrasound) unit? Check the exact model rather than relying on similar photos or treatment claims.
Listed manufacturer for this profile: BTL Industries
- FDA record: Match any claimed 510(k) or De Novo number to the exact model and applicant in the FDA database.
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We do not profile these unbranded units or verify their support and financing terms. This profile’s FDA record applies to the named device, not every similar-looking unit.
Treatment & running costs
Treatments
Sessions & timing
No treatment schedule documented yet.
What practices charge
No sourced treatment price on file.
Supplies & recurring costs
Supply pricing is not documented with a dated source yet. Request an itemized supply quote.
Source notes
Dalton Medical tip listing; per-treatment figure derived from box price and count. Currency as published, not converted.
30 Aug 2026 research pass.
Annual service & support
No annual service cost documented yet.
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ComplianceScreening and contraindications on the manufacturer's record
Contraindications & screening
Implanted electronic devices, metal in the field, pregnancy, active infection; for Fractional RF add keloid history, isotretinoin timing, active acne flares, plus standard pigment-risk counseling (RF needles are relatively color-safe — a real advantage).
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History3 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
September 8, 2026
FDA K-numbers
K211639; K242532 → K211639; K222556; K233604
Source: Record correction
September 8, 2026
FDA source URL
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211639
Source: Record correction
August 1, 2026
Record created
Added to The Aesthetic Index — August 2026
Source: The Aesthetic Index editorial
Cite this data: The Aesthetic Index, "BTL Aesthetics Exion — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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