Syneron VelaSmooth
Vacuum/massage-based · Bipolar RF + infrared + vacuum rollers (elos)
Disclosure: the founder of The Aesthetic Index owns DNA Distribution, the North American distributor of the Cryoskin Revolution, which competes with this device. Ownership & conflicts.
At a glance
- New-unit reference · older model
- Not published
- Used asking price
- $3k–$8kSource 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 ClearedK050397
- 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
K050397 (Syneron Medical, Ltd., 2005)
The Vela smooth, Shaper is indicated for the relief of minor muscle aches and pain. Relief of muscle spasm Temporary improvement of local blood circulation. Temporary reduction in the appearance of cellulite.
Verbatim from the FDA 510(k) summary, retrieved 18 Sep 2026.
Page updated: September 18, 2026 · How we verify
No new-unit price reference is published for this older model.
Axis runs $0–$8k. 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 |
|---|---|
| Company | Owner: Apax Partners (funds advised by Apax) (private equity owned, since 2017) · Distribution: direct |
| Parent company | Candela Medical |
| Brand owner | Syneron |
| Built by (OEM) | Syneron Medical Ltd. |
| Category | Body Contouring |
| Technology | Bipolar RF + infrared + vacuum rollers (elos) |
| FDA status | FDA Cleared |
| 510(k) citation | K050397 |
| New-unit reference (older model) | Not published |
| Used asking range | $3k–$8k |
| Consumables | Not published |
| Launch year | 2005 |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
First FDA-cleared cellulite reduction device
FDA & regulatory detailClearance timeline, authorization route and citation notes
K050397 names Vela smooth, Shaper. Its Indications for Use statement does not list thigh-circumference reduction. The earlier catalog summary included that unsupported claim; it was removed after checking the FDA PDF on September 18, 2026.
FDA-cleared indications (verbatim)
K050397 (Syneron Medical, Ltd., 2005)
The Vela smooth, Shaper is indicated for the relief of minor muscle aches and pain. Relief of muscle spasm Temporary improvement of local blood circulation. Temporary reduction in the appearance of cellulite.
Verbatim from the FDA 510(k) summary, retrieved 18 Sep 2026.
Marketed for
Vacuum/massage-based — Bipolar RF + infrared + vacuum rollers (elos)
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
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.
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 VelaSmooth 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
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Current alternatives
Current catalog models to research. Confirm availability and configuration with the supplier.
History9 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
September 18, 2026
fda ifu
September 18, 2026: Astra visually transcribed the complete Indications for Use block from FDA PDF page 4. Original wording and punctuation retained; line wraps and bullet glyphs normalized. Prior automated extraction was incomplete or unreadable. This is the clearance indication statement, not the complete operator manual.
Source: https://www.accessdata.fda.gov/cdrh_docs/pdf5/K050397.pdf
September 18, 2026
FDA indication
Source: Catalog update
September 18, 2026
FDA source URL
https://www.accessdata.fda.gov/cdrh_docs/pdf5/K050397.pdf
Source: Catalog update
September 18, 2026
fda search completed on
2026-09-18
September 18, 2026: Astra visually transcribed the complete Indications for Use block from FDA PDF page 4. Original wording and punctuation retained; line wraps and bullet glyphs normalized. Prior automated extraction was incomplete or unreadable. This is the clearance indication statement, not the complete operator manual.
Source: https://www.accessdata.fda.gov/cdrh_docs/pdf5/K050397.pdf
September 18, 2026
fda scope note
Removed unsupported thigh-circumference claim; cited FDA indication statement checked directly.
Source: https://www.accessdata.fda.gov/cdrh_docs/pdf5/K050397.pdf
August 5, 2026
FDA status
Unknown → Cleared
Source: Catalog update
August 5, 2026
FDA indication
IR light + bipolar RF + vacuum massage: cellulite, thigh circumference
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 VelaSmooth — pricing, FDA status and cost to own", aestheticindex.co (accessed September 24, 2026).
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