BTL Aesthetics Exion Fractional RF
RF Microneedling · Monopolar RF microneedling + AI needle-free energy
Technology: RF Microneedling
Classification & configurations
Category group: Skin tightening & remodeling (RF microneedling, monopolar RF, HIFU)
At a glance
- New price
- $30k–$45kSource not documented
- Used asking price
- $14k–$25kSource 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
- 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. Used asking prices are not completed-sale values.
Read 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 22, 2026 · How we verify
Axis runs $0–$45k. 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 | 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 | RF Microneedling |
| Technology | Monopolar RF microneedling + AI needle-free energy |
| FDA status | FDA Cleared |
| 510(k) citation | K211639, K222556, K233604 |
| New price range | $30k–$45k |
| Used asking range | $14k–$25k |
| Consumables | Not published |
| Launch year | 2022 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
Claims deeper effect without full needle depth
FDA & regulatory detailClearance timeline, authorization route and citation notes
Platform clearance: K211639 (BTL-785W, decision 7 Mar 2022) covers the BTL-785-4 applicator with microneedle tips 'for dermatological procedures requiring fractional treatment of the skin'; family clearances K222556 (BTL-785X, 31 May 2023) and K233604 (BTL-785S, 28 Mar 2024). FDA names the device by model number, not 'Exion'. 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
Radiofrequency — monopolar — Monopolar RF microneedling + AI needle-free energy
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.
FDA safety actions
Recorded recalls, warning letters and safety communications. Terminated actions remain visible as history.
How we report safety actionsChecked 7 Sep 2026 against FDA enforcement data dated 2 Sep 2026.
- FDA safety communicationFDA safety communication, issued 15 October 2025Open
Initiated Oct 15, 2025
Scope as FDA lists it
Applies to RF microneedling devices used for dermatologic or aesthetic procedures intended to improve the appearance of the skin. FDA is aware of reports of burns, scarring, fat loss, disfigurement and nerve damage, and of injuries needing surgical repair.
FDA advises providers to discuss these risks with patients and to report complications.
Reason and action
FDA advises providers to discuss these risks with patients before treatment, to use devices only as cleared, and to report complications to MedWatch. FDA did not name individual brands; the communication covers 510(k)-cleared RF microneedling devices as a class.
This communication applies to a class of devices, not to a specific unit or recall.
This is an FDA communication about a device class, not a recall of specific units; read the FDA notice for the reported risks and FDA's recommendations.
Manufacturer response: none on file — manufacturers can reply via their company profile.
FDA record
Look-alike devices
Comparing an unbranded RF microneedling 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.
- Support: Get written warranty, training, consumables and service terms from the seller.
- Financing: Confirm availability for the exact unit before including it in your budget.
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
Consumable costs are not documented yet.
Annual service & support
No annual service cost documented yet.
Payback calculatorModel your own volume, labor and service costs
Estimate your payback
Pre-filled from our published BTL Aesthetics Exion Fractional RF data where we have it. Estimates appear once the required inputs are available. Review and adjust every pre-filled value before relying on the result.
Start from
No verified per-treatment supply cost is on file. Enter your own allowance. Use $0 only if you have confirmed that it applies to your practice.
Pre-filled from the midpoint of the published new-price range
20 is an illustrative default — change it to your volume.
No sourced per-session price on file — enter what you charge.
Required — enter your cost; missing data does not mean $0.
Provider or tech time for one treatment, fully loaded. Enter 0 if you own-operate.
Annual service contract ÷ 12, if you carry one.
Your estimate
Enter price you charge per treatment, consumable cost per treatment to see contribution and a payback range.
This model ignores financing — if you lease or borrow, add your monthly payment. Estimates from your inputs and our published ranges — not a projection, guarantee or financial advice. How we calculate this.
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
Write a reviewNo owner or operator reviews yet. Be the first →
Current alternatives
Current catalog models to research. Confirm availability and configuration with the supplier.
History5 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
September 22, 2026
Exact-model treatment modality
{"technology_subcategory": "Radiofrequency — monopolar"} → {"technology_subcategory": "RF Microneedling"}
Exact-model treatment modality corrected from the cited primary source. Prior catalog fields retained in this history entry. No review, price, availability or regulatory-status change.
Source: https://bodybybtl.com/solutions/exion
September 8, 2026
FDA status
Unknown → Cleared
Source: Record correction
September 8, 2026
FDA K-numbers
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 Fractional RF — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
Get the full State of Aesthetic Devices 2026 report
A catalog of US-marketed aesthetic and wellness devices — preview it free.
Device and company names are trademarks of their respective owners. The Aesthetic Index is not affiliated with or endorsed by any manufacturer, distributor or lender named here, except as disclosed. Price figures are references, not current offers. Check each device’s source notes. Not medical, legal or regulatory advice.