← Back to catalogue

Exilis XP

FDA 510(k)

Class II (US FDA 510(k))

510(k) K143040

by BTL Industries, Inc.

Identifiers

510(k) Number
K143040 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 Exilis XP is a Vacuum, Radio Frequency Induced Heat Massager, designed for non-invasive body contouring and skin tightening. It combines radiofrequency energy with vacuum suction to target subcutaneous fat and collagen, promoting tissue remodeling and skin firmness in targeted areas such as the abdomen, thighs, and arms.

This device is intended for use in clinical settings by trained professionals, such as plastic surgeons or aesthetic practitioners. Supplied as a reusable medical instrument, it operates under 21 CFR 878.4400 and has received FDA 510(k) clearance (K143040) as substantially equivalent to predicate devices. It is not classified as MRI-safe or sterile and requires proper storage and maintenance as per manufacturer guidelines.

Frequently asked questions

What clinical specialties are primarily responsible for using the Exilis XP, and why is this device intended for professional use only?

The Exilis XP is primarily intended for use by trained professionals in the fields of general and plastic surgery, as indicated by its advisory committee classification. It is designed for clinical settings because it combines radiofrequency energy with vacuum suction to target subcutaneous fat and collagen, requiring expertise to ensure safe and effective application. Non-invasive body contouring and skin tightening procedures like those performed with this device demand professional oversight to minimize risks and achieve optimal results.

Is the Exilis XP a single-use device, or can it be reused after cleaning and maintenance? How should it be stored?

The Exilis XP is a reusable medical instrument, meaning it is not intended for single-use. Like all reusable devices, it requires proper cleaning, maintenance, and storage as outlined by the manufacturer to ensure safety and functionality. The manufacturer’s guidelines must be followed to prevent contamination and maintain performance, particularly since it is not classified as sterile.

What specific body areas can the Exilis XP be used on, and how does it work to achieve its intended effects?

The Exilis XP is designed for non-invasive body contouring and skin tightening in targeted areas such as the abdomen, thighs, and arms. It works by combining radiofrequency energy with vacuum suction to target subcutaneous fat and stimulate collagen remodeling. This dual-action approach promotes tissue remodeling and skin firmness, helping to improve the appearance of treated areas over time.

What regulatory pathway did the Exilis XP follow to gain clearance, and what does this mean for its use in clinical practice?

The Exilis XP received FDA 510(k) clearance (K143040) under the traditional review pathway, demonstrating it is substantially equivalent to predicate devices already on the market. This clearance indicates that the device meets FDA safety and effectiveness requirements for its intended use in non-invasive body contouring and skin tightening. Clinicians can rely on this approval to ensure the device adheres to regulatory standards for professional use in clinical settings.

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. Sources consulted: Exilis Xp 510 (k) FDA Premarket Notification K143040 BTL INDUSTRIES INC, PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and ..., fda.innolitics.com, fda.innolitics.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
BTL Industries, Inc.

Sources (1)

  • FDA 510(k) K143040 24 fields · synced Sep 19, 2026