BTL Aesthetics Exilis Ultra 360
RF body contouring · RF + ultrasound, 360 applicators
Technology: HIFU & Ultrasound
At a glance
- New price
- $60k–$90kSource not documented
- Used asking price
- $20k–$45kSource not documented
- 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. Used asking prices are not completed-sale values.
Read FDA-cleared indicationsExact wording from 3 FDA records
K092191 (Btl Industries, Ltd., 2009)
The EXILIS device is indicated for the primary treatment of dermatologic and general surgical procedures for non-invasive treatment of wrinkles and rhytids. EXILIS is a state-of-the-art device to apply therapy by a non-invasive method of high-frequency field.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K143040 (BTL Industries, Inc., 2015)
The Exilis XP RF device 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 Exilis XP massage device is intended to provide a temporary reduction in the appearance of cellulite.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K163176 (BTL Industries, Inc., 2017)
The Exilis XP II RF device 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 Exilis XP II massage device is intended to provide a temporary reduction in the appearance of cellulite.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: August 6, 2026 · How we verify
Axis runs $0–$90k. 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 | Body Contouring |
| Technology | RF + ultrasound, 360 applicators |
| FDA status | FDA Cleared |
| 510(k) citation | K092191, K143040, K163176 |
| New price range | $60k–$90k |
| Used asking range | $20k–$45k |
| Consumables | Not published |
| Launch year | 2016 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
Face and body tightening, current model
How it worksTechnology and manufacturing
How the technology works
Focused monopolar RF layered with ultrasound, which disrupts the stratum corneum's impedance barrier and lets RF heat deeper, more uniformly, and more comfortably than RF alone.
Controlled dermal/subcutaneous heating triggers collagen denaturation and neocollagenesis, and at higher settings adipocyte apoptosis for mild fat reduction. Integrated cooling in the body applicator selects treatment depth — cooling on for deep fat, off for superficial tightening.
Typical protocols: four weekly sessions, results over 3 months.
Patented technology
BTL's patented simultaneous RF-plus-ultrasound delivery and EFC (Energy Flow Control) impedance monitoring holding tissue at target temperature; the 360-degree volumetric small applicator enables the Ultra Femme 360 intravaginal protocol on the same console.
Origin
Czech Republic (BTL Industries).
FDA & regulatory detailClearance timeline, authorization route and citation notes
FDA-cleared indications (verbatim)
K092191 (Btl Industries, Ltd., 2009)
The EXILIS device is indicated for the primary treatment of dermatologic and general surgical procedures for non-invasive treatment of wrinkles and rhytids. EXILIS is a state-of-the-art device to apply therapy by a non-invasive method of high-frequency field.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K143040 (BTL Industries, Inc., 2015)
The Exilis XP RF device 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 Exilis XP massage device is intended to provide a temporary reduction in the appearance of cellulite.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
K163176 (BTL Industries, Inc., 2017)
The Exilis XP II RF device 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 Exilis XP II massage device is intended to provide a temporary reduction in the appearance of cellulite.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
HIFU / Ultrasound — RF + ultrasound, 360 applicators
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, 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.
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.
- 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
Supply pricing is not documented with a dated source yet. Request an itemized supply quote.
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 Exilis Ultra 360 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.
ComplianceScreening and contraindications on the manufacturer's record
Contraindications & screening
Metal implants, pacemakers/defibrillators, pregnancy are the monopolar hard stops; avoid recent filler or threads until settled; standard cautions for impaired sensation and active skin disease.
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
Current catalog models to research. Confirm availability and configuration with the supplier.
Research comparisons
Includes current and older models.
History2 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
August 5, 2026
Warranty & service
Source: Catalog update
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 Exilis Ultra 360 — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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