Syneron VelaSmooth

Vacuum/massage-based · Bipolar RF + infrared + vacuum rollers (elos)

DiscontinuedBe the first to review

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

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Overview

First FDA-cleared cellulite reduction device

FDA & regulatory status

Cleared via 510(k)

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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History

Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.

  1. August 5, 2026

    FDA status

    UnknownCleared

    Source: Automatic record update

  2. August 5, 2026

    FDA K-numbers

    K050397

    Source: Automatic record update

  3. August 5, 2026

    FDA indication

    IR light + bipolar RF + vacuum massage: cellulite, thigh circumference

    Source: Automatic record update

  4. August 1, 2026

    Record created

    Added to The Aesthetic Index — August 2026

    Source: The Aesthetic Index editorial

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