Classys Ultraformer MPT
HIFU/Ultrasound Lifting · Micro-pulsed HIFU (2mm boost mode)
What it's actually cleared for: No 510(k) exists for Ultraformer HIFU — US units are gray-market imports; Classys cleared other devices (Volnewmer, Scizer) instead
Last verified: August 6, 2026 · How we verify
New: $40k–$70k|Used: $25k–$45kmarket estimate, no email required
Overview
Faster MMFU firing vs Ultraformer III
FDA & regulatory status
What it's actually cleared for:
No 510(k) exists for Ultraformer HIFU — US units are gray-market imports; Classys cleared other devices (Volnewmer, Scizer) instead
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 indication
No Classys HIFU 510(k) exists; documented US gray-market import → No 510(k) exists for Ultraformer HIFU — US units are gray-market imports; Classys cleared other devices (Volnewmer, Scizer) instead
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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