TheAesthetic Index

Classys Ultraformer MPT

HIFU/Ultrasound Lifting · Micro-pulsed HIFU (2mm boost mode)

Work at Classys? — one claim covers all 4 of your devices.
CurrentBe the first to review

The Classys Ultraformer MPT typically sells new in the $40k–$70k range in the US, with used and refurbished systems around $25k–$45k. Classys Ultraformer MPT has no US FDA clearance on file. Figures are market estimates verified August 6, 2026.

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

Key facts
ManufacturerClassys
CompanyOwner: Bain Capital (majority, being reduced) plus the founder Jung Sung-jae family (minority) (private equity owned, since 2022) · Distribution: hybrid (direct + distributor) — Cartessa Aesthetics (Volnewmer RF, US-branded Everesse, in North America)
CategoryRF Microneedling, Tightening & HIFU
TechnologyMicro-pulsed HIFU (2mm boost mode)
FDA statusNot FDA cleared
New price range$40k–$70k
Used price range$25k–$45k
ConsumablesNot published
Launch year2023
Last verifiedAugust 6, 2026
Save device

Overview

Faster MMFU firing vs Ultraformer III

FDA & regulatory status

No US clearance on file

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.

Recent industry events

How we source company data

Ownership and corporate changes at Classys that can affect warranty, service and parts availability.

  1. Apr 2022

    Bain Capital acquires 60.84% of Classys

    Acquisition

    Bain Capital acquired 39.41M Classys shares (60.84%) for KRW 669.9B ($556.7M) at KRW 17,000/share, agreed January 27, 2022 and closed April 5, 2022. A subsequent control-sale process launched in October 2024 stalled; Bain has since trimmed its stake via block trades.

    Source: Korea Biomed; KED Global

Treatment economics

Economics data for this platform hasn't been published yet.

Chains using this device

No confirmed chain deployments recorded yet.

Owner reviews

Write a review

No verified reviews yet — be the first. Founding reviewers get a thank-you gift card for an honest review, positive or negative. How verification works.

Alternatives

Ulthera (Merz) Ulthera System (Ultherapy)

HIFU/Ultrasound Lifting · $130k–$175k

ProfileCompare

Hironic Doublo Gold

HIFU/Ultrasound Lifting

ProfileCompare

Jeisys ULTRAcel

HIFU/Ultrasound Lifting

ProfileCompare

Jeisys ULTRAcel Zii

HIFU/Ultrasound Lifting

ProfileCompare

Head-to-head comparisons buyers ask for

History

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

  1. 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

  2. August 1, 2026

    Record created

    Added to The Aesthetic Index — August 2026

    Source: The Aesthetic Index editorial

Get the full State of Aesthetic Devices 2026 report

The first full census of the US aesthetic device market — preview it free.

Get the report