TheAesthetic Index

Cutera truSculpt 3D

RF body contouring · Monopolar RF, glide technique

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New Cutera truSculpt 3D pricing is not published; used and refurbished systems trade around $15k–$30k. Cutera truSculpt 3D holds FDA 510(k) clearance for its marketed indication. Figures are market estimates verified August 6, 2026.

What it's actually cleared for: RF deep heating/body sculpting

Last verified: August 6, 2026 · How we verify

New: —|Used: $15k–$30kmarket estimate, no email required

Key facts
ManufacturerCutera
CompanyOwner: Private; held by former lenders following Chapter 11 restructuring (private equity owned, since 2025) · Distribution: direct
CategoryBody Contouring
TechnologyMonopolar RF, glide technique
FDA statusFDA Cleared
New price rangeNot published
Used price range$15k–$30k
ConsumablesNot published
Launch year2017
Last verifiedAugust 6, 2026
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Overview

Second generation

FDA & regulatory status

Authorized via 510(k)

What it's actually cleared for:

RF deep heating/body sculpting

510(k) numbers

K172004; K180709

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 Cutera that can affect warranty, service and parts availability.

  1. Mar 2025

    Cutera files Chapter 11 and emerges private

    Bankruptcy
    Service & warranty risk

    Cutera filed for Chapter 11 bankruptcy protection on March 5-6, 2025 and was delisted from NASDAQ that month. It emerged from bankruptcy on May 1, 2025 as a private company held by its former lenders, cutting debt by ~$400M (over 90%) and raising $65M of new capital. Buyers should confirm current warranty, service and parts commitments directly.

    Source: SEC filings; Lexology; The D&O Diary

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

    Unknown → Cleared

    Source: Automatic record update

  2. August 5, 2026

    FDA K-numbers

    K172004; K180709

    Source: Automatic record update

  3. August 5, 2026

    FDA indication

    RF deep heating/body sculpting

    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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