TheAesthetic Index

Classys Shurink Universe

HIFU/Ultrasound Lifting · Dual-mode HIFU

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New Classys Shurink Universe pricing is not published; used and refurbished systems trade around $10k–$20k. Classys Shurink Universe has no US FDA clearance on file. Figures are market estimates verified August 6, 2026.

What it's actually cleared for: Korean-market Ultraformer family name; no 510(k)

Last verified: August 6, 2026 · How we verify

New: —|Used: $10k–$20kmarket 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
TechnologyDual-mode HIFU
FDA statusNot FDA cleared
New price rangeNot published
Used price range$10k–$20k
ConsumablesNot published
Launch year2022
Last verifiedAugust 6, 2026
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Overview

Korea's high-volume HIFU platform

FDA & regulatory status

No US clearance on file

What it's actually cleared for:

Korean-market Ultraformer family name; no 510(k)

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

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History

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

  1. August 1, 2026

    Record created

    Added to The Aesthetic Index — August 2026

    Source: The Aesthetic Index editorial

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