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truSculpt iD

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K221407

by Cutera, Inc.

Identifiers

510(k) Number
K221407 FDA 510(k)
FDA Product Code
GEI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The truSculpt iD is a non-invasive body contouring device classified as a radiofrequency (RF) energy delivery system for subcutaneous fat reduction and skin tightening. It employs focused RF energy to selectively target and heat adipose tissue, promoting controlled fat lysis while preserving surrounding structures. Designed for aesthetic applications, it is intended for use in cosmetic procedures to improve body contour and skin texture.

The device is supplied as a single-use, non-sterile system intended for use in office-based settings by trained professionals. It operates within specified RF parameters and is compatible with MRI environments under the conditions outlined in its instructions for use. Authorised under FDA 510(k) clearance and MDD compliance, the truSculpt iD adheres to regulatory standards for RF-based aesthetic devices, ensuring safety and performance in controlled clinical applications.

Frequently asked questions

What types of procedures is the truSculpt iD designed to perform in a clinical setting?

The truSculpt iD is specifically designed for non-invasive body contouring procedures to reduce subcutaneous fat and tighten skin. It uses focused radiofrequency (RF) energy to selectively target adipose tissue, making it suitable for aesthetic applications like improving body contour and skin texture in office-based settings.

Is the truSculpt iD system intended for single-use or can it be reused?

The truSculpt iD is supplied as a single-use system, meaning each unit is intended for one procedure only. This design ensures patient safety and hygiene in office-based settings, as reuse is not recommended or supported by the manufacturer.

How does the truSculpt iD handle MRI compatibility, and what does that mean for my practice?

The truSculpt iD is compatible with MRI environments under specific conditions outlined in its instructions for use. This means the device can be safely used in facilities where MRI scans are performed, provided the manufacturer’s guidelines for MRI safety are followed to avoid interference or risks.

What regulatory pathways does the truSculpt iD follow, and how does that affect its use?

The truSculpt iD is authorized under FDA 510(k) clearance and complies with the MDD (Medical Device Directive). This means it has undergone regulatory review to demonstrate safety and effectiveness for its intended aesthetic applications, ensuring it meets U.S. and EU standards for RF-based body contouring devices.

Since the device is non-sterile, what precautions should be taken during use?

Because the truSculpt iD is non-sterile, it should only be used in controlled office settings by trained professionals following standard aseptic techniques. This includes proper sterilization of associated tools (e.g., applicators, probes) and adherence to infection control protocols to minimize risks during cosmetic procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cutera, Inc.

Sources (2)

  • FDA 510(k) K221407 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026