Syneron VelaSmooth
Vacuum/massage-based · Bipolar RF + infrared + vacuum rollers (elos)
New Syneron VelaSmooth pricing is not published; used and refurbished systems trade around $3k–$8k. Syneron VelaSmooth holds FDA 510(k) clearance for its marketed indication. Figures are market estimates verified August 6, 2026.
What it's actually cleared for: IR light + bipolar RF + vacuum massage: cellulite, thigh circumference
Last verified: August 6, 2026 · How we verify
New: —|Used: $3k–$8kmarket estimate, no email required
| Manufacturer | Syneron |
|---|---|
| Company | Owner: Apax Partners (funds advised by Apax) (private equity owned, since 2017) · Distribution: direct |
| Category | Body Contouring |
| Technology | Bipolar RF + infrared + vacuum rollers (elos) |
| FDA status | FDA Cleared |
| New price range | Not published |
| Used price range | $3k–$8k |
| Consumables | Not published |
| Launch year | 2005 |
| Last verified | August 6, 2026 |
Overview
First FDA-cleared cellulite reduction device
FDA & regulatory status
What it's actually cleared for:
IR light + bipolar RF + vacuum massage: cellulite, thigh circumference
510(k) numbers
K050397
Regulatory data is compiled from public FDA 510(k) records and may lag recent clearances. Always confirm status with the manufacturer before purchase.
Treatment economics
Economics data for this platform hasn't been published yet.
Chains using this device
No confirmed chain deployments recorded yet.
Owner reviews
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Alternatives
History
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
August 5, 2026
FDA status
Unknown → Cleared
Source: Automatic record update
August 5, 2026
FDA K-numbers
K050397
Source: Automatic record update
August 5, 2026
FDA indication
IR light + bipolar RF + vacuum massage: cellulite, thigh circumference
Source: Automatic record update
August 1, 2026
Record created
Added to The Aesthetic Index — August 2026
Source: The Aesthetic Index editorial
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