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Swift System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K181941

by Emblation , Ltd.

Identifiers

510(k) Number
K181941 FDA 510(k)
FDA Product Code
NEY 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 Swift System is a Microwave Ablation System and Accessories designed for targeted tissue treatment. It delivers controlled microwave energy to precisely ablate skin lesions, including verrucas and warts, without disrupting the surrounding skin surface. The device operates within the regulatory classification of Class II medical devices, adhering to standards for microwave ablation technology.

The system is intended for use in clinical settings by trained healthcare professionals. It is supplied as a reusable device with disposable accessories, ensuring sterility and single-use compliance for patient safety. The Swift System is authorised under FDA 510K and MDR, with a regulatory designation of Substantially Equivalent to predicate devices. Storage and handling follow manufacturer guidelines to maintain performance and sterility.

Frequently asked questions

What types of skin lesions is the Swift System designed to treat, and how does it work?

The Swift System is specifically designed to treat skin lesions such as verrucas and warts. It delivers controlled microwave energy to precisely ablate the targeted tissue, effectively removing the lesion while preserving the surrounding skin surface. The microwave energy ensures a focused treatment without causing significant disruption to healthy tissue.

Is the Swift System reusable, and how are the disposable accessories handled for patient safety?

The Swift System itself is a reusable device, but it comes with disposable accessories that are intended for single-use. This design ensures sterility and patient safety, as each accessory is used only once and discarded afterward, reducing the risk of cross-contamination.

What regulatory pathways has the Swift System followed, and what does this mean for its use in clinical settings?

The Swift System has been authorized through the FDA 510K pathway and the EU’s Medical Device Regulation (MDR), with a classification as Substantially Equivalent to predicate devices. This means it has undergone rigorous review to demonstrate safety and effectiveness compared to existing devices, allowing trained healthcare professionals to use it in clinical settings for targeted microwave ablation of skin lesions.

Are there specific storage or handling instructions for the Swift System to maintain its performance and sterility?

Yes, the Swift System must be stored and handled according to the manufacturer’s guidelines to ensure optimal performance and sterility. While the exact details aren’t provided here, proper storage typically involves keeping the reusable components clean, dry, and protected from contamination, while disposable accessories should remain in sealed packaging until 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. Sources consulted: Emblation - Global Swift Website, SWIFT - Wikipedia, Our devices - Emblation

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Emblation , Ltd.

Sources (2)

  • FDA 510(k) K181941 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026