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VivAer Stylus

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K200300

by Aerin Medical Inc.

Identifiers

510(k) Number
K200300 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 VivAer Stylus is a surgical instrument designed for use in plastic surgery procedures. It is classified as a surgical cutting instrument and features a stylus tip for precise tissue manipulation and shaping, aiding in contouring and sculpting during aesthetic or reconstructive surgeries.

Supplied sterile and intended for single-use, the VivAer Stylus is manufactured by Aerin Medical Inc. It is approved under FDA 510K clearance (K200300) and MDR, with a product code of GEI under the General, Plastic Surgery advisory committee. The device is non-magnetic and intended for use in non-MRI environments.

Frequently asked questions

What types of plastic surgery procedures is the VivAer Stylus designed to assist with, and how does its stylus tip help in those procedures?

The VivAer Stylus is specifically designed for use in both aesthetic and reconstructive plastic surgery procedures. Its stylus tip provides precise tissue manipulation and shaping, which aids in contouring and sculpting during surgeries. This level of control is particularly useful for creating smooth, natural-looking results in procedures such as liposuction, fat grafting, or tissue reshaping.

Is the VivAer Stylus reusable, or is it intended for single-use only? How does this impact its use in a clinical setting?

The VivAer Stylus is supplied sterile and explicitly intended for single-use only. This design ensures patient safety by eliminating the risk of cross-contamination between procedures, which is critical in sterile surgical environments. Clinicians should follow standard single-use protocols, including proper disposal after one use.

What storage conditions should be followed for the VivAer Stylus to maintain its sterility and performance?

Since the VivAer Stylus is supplied sterile, it should be stored in its original, unopened packaging until ready for use. The packaging is designed to protect the device from contamination and damage. Once opened, the device must be used immediately and disposed of after a single procedure to preserve sterility and prevent reuse-related risks.

Can the VivAer Stylus be used in an MRI environment, or is it restricted to non-MRI settings?

The VivAer Stylus is explicitly non-magnetic and intended for use only in non-MRI environments. This restriction is due to potential interference or safety risks if the device were exposed to magnetic fields, which could compromise imaging accuracy or patient safety during MRI 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

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Aerin Medical Inc.
FDA Applicant
Aerin Medical, Inc.

Sources (2)

  • FDA 510(k) K200300 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026