Syneron-Candela UltraShape
Ultrasound/HIFU fat reduction · Pulsed focused ultrasound (non-thermal)
What it's actually cleared for: Pulsed focused ultrasound: non-invasive abdomen circumference reduction (filed as Contour I V3.1)
Last verified: August 6, 2026 · How we verify
New: —|Used: $10k–$25kmarket estimate, no email required
Overview
Mechanical fat cell destruction
FDA & regulatory status
What it's actually cleared for:
Pulsed focused ultrasound: non-invasive abdomen circumference reduction (filed as Contour I V3.1)
510(k) numbers
K133238
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
K133238
Source: Automatic record update
August 5, 2026
FDA indication
Pulsed focused ultrasound: non-invasive abdomen circumference reduction (filed as Contour I V3.1)
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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