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EmBody System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K183450

by Inmode MD , Ltd.

Identifiers

510(k) Number
K183450 FDA 510(k)
FDA Product Code
PBX 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 EmBody System is a Vacuum, Radio Frequency Induced Heat Massager, classified under FDA device class 2. It combines suction, radiofrequency energy, and heat to promote tissue remodeling and enhance aesthetic outcomes, primarily in plastic surgery applications. The device is designed to improve skin elasticity, reduce cellulite, and contour body contours through targeted thermal and mechanical stimulation.

The system is supplied as a reusable medical device, intended for use in clinical settings by trained professionals. It is not MRI-safe and requires proper sterilization between uses. The device operates under FDA 510(k) clearance (K183450) and EU MDR compliance, adhering to regulatory standards for aesthetic and body contouring procedures. No single-use components are specified, and storage conditions must follow manufacturer guidelines to maintain performance and sterility.

Frequently asked questions

What clinical specialties is the EmBody System primarily intended for use in, and how does it support those fields?

The EmBody System is designed for use in plastic surgery settings, as indicated by its classification under the FDA’s General, Plastic Surgery advisory committee. It combines suction, radiofrequency energy, and heat to promote tissue remodeling, improve skin elasticity, reduce cellulite, and contour body shapes—common goals in aesthetic and reconstructive plastic surgery procedures.

Is the EmBody System safe for use in an MRI environment, and what precautions should be taken during its operation?

The EmBody System is not MRI-safe, meaning it should never be used or stored in an MRI facility. Since it incorporates radiofrequency energy and mechanical components, exposure to MRI fields could pose risks to both the device and patients. Always follow manufacturer guidelines for safe handling and ensure the device is removed from MRI environments.

How is the EmBody System sterilized between clinical uses, and what storage conditions are required to maintain its performance?

The EmBody System is a reusable medical device and must be properly sterilized between uses to prevent cross-contamination. Sterilization methods should align with manufacturer recommendations (likely autoclave or chemical sterilization). Storage conditions must also follow the manufacturer’s instructions to preserve sterility and functionality, as improper storage could degrade performance or compromise safety.

Does the EmBody System come with disposable components, or is it fully reusable with no single-use attachments?

The EmBody System is fully reusable—there are no specified single-use components listed in its documentation. However, accessories like applicators or attachments may require cleaning or sterilization between patients, depending on their design. Always verify with the manufacturer for specific care instructions.

What regulatory pathways does the EmBody System follow in the U.S. and Europe, and how does this affect its availability?

In the U.S., the EmBody System is cleared under the FDA 510(k) pathway (K183450) as a Class II device, meaning it has undergone premarket review to demonstrate substantial equivalence to a predicate device. In Europe, it complies with EU MDR (Medical Device Regulation), ensuring it meets stringent safety and performance standards before market authorization. Availability depends on compliance with these regulatory requirements, and clinicians should confirm local regulatory approvals before use.

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

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Inmode MD , Ltd.

Sources (2)

  • FDA 510(k) K183450 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026