Syneron-Candela UltraShape
Ultrasound/HIFU fat reduction · Pulsed focused ultrasound (non-thermal)
Technology: HIFU & Ultrasound
At a glance
- New-unit reference · older model
- Not published
- Used asking price
- $10k–$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
- FDA
- FDA ClearedK133238
- 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 1 FDA record
K133238 (Syneron Medical, Ltd., 2014)
The Contour I V3.1 System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: August 6, 2026 · How we verify
No new-unit price reference is published for this older model.
Axis runs $0–$25k. 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 | Syneron-Candela |
|---|---|
| Company | Owner: Apax Partners (funds advised by Apax) (private equity owned, since 2017) · Distribution: direct |
| Parent company | Candela Medical |
| Brand owner | Syneron-Candela |
| Built by (OEM) | Syneron Medical Ltd. |
| Category | Body Contouring |
| Technology | Pulsed focused ultrasound (non-thermal) |
| FDA status | FDA Cleared |
| 510(k) citation | K133238 |
| New-unit reference (older model) | Not published |
| Used asking range | $10k–$25k |
| Consumables | Not published |
| Launch year | 2014 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
Mechanical fat cell destruction
FDA & regulatory detailClearance timeline, authorization route and citation notes
FDA-cleared indications (verbatim)
K133238 (Syneron Medical, Ltd., 2014)
The Contour I V3.1 System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
HIFU / Ultrasound — Pulsed focused ultrasound (non-thermal)
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
510(k) numbers
Parent company: Candela Medical
Legal manufacturer: Syneron Medical Ltd. (Israel)
Applicant on the FDA record
Syneron Medical, 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: Syneron Medical Ltd.
- 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 Syneron-Candela UltraShape 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 used asking 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.
History4 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
August 5, 2026
FDA status
Unknown → Cleared
Source: Catalog update
August 5, 2026
FDA indication
Source: Catalog update
August 5, 2026
FDA K-numbers
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, "Syneron-Candela UltraShape — 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.
Explore this model’s specs and owner reviews. For new-equipment inquiries, browse current models.
Browse current modelsDevice 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.