swiftPro? System
Emblation Limited
EMBLATION LIMITED
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010933564 | 3010933564 | EMBLATION LIMITED | 1 | N | 2026-01-01 | Emblation House Castle Business Park Stirling Stirling GB FK9 4TS |
| 3015152398 | 3015152398 | Emblation Inc. | 1 | Y | 2026-01-01 | 42 Albion Rd Lincoln RI US 02865 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 225431 | 1674294659 | K250718 | swiftPro System (SWF-SPS); Swift System (SWF-SYS) | NEY | 2025-08-08 |
| 177445 | 1702445782 | K250718 | swiftPro System (SWF-SPS); Swift System (SWF-SYS) | NEY | 2025-08-08 |
| 225431 | 1510687728 | K240518 | swiftPro™ System | NEY | 2024-04-23 |
| 177445 | 1724719266 | K240518 | swiftPro™ System | NEY | 2024-04-23 |
| 225431 | 1122577686 | K222388 | swiftPro System | NEY | 2023-05-04 |
| 177445 | 1628174217 | K222388 | swiftPro System | NEY | 2023-05-04 |
| 177445 | 1210207982 | K200796 | Emprint Ablation System with Thermosphere Technology | NEY | 2020-08-26 |
| 177445 | 1012918376 | K181941 | Swift System | NEY | 2018-10-18 |
| 177445 | 1260116059 | K133821 | EMPRINT ABLATION SYSTEM | NEY | 2014-04-28 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| NEY | 9 | 2025-08-08 |
PMN#
swiftPro System
Emblation , Ltd.
Swift System
Emblation Ltd
GUDID#
Swiftips - Box of ten SwiftPro applicator Swiftips. Swiftips are provided as a single use, non-sterile disposable tip, which is connected to the SwiftPro device.
2026-06-08
Swiftips - Box of ten SwiftPro applicator Swiftips. Swiftips are provided as a single use, non-sterile disposable tip, which is connected to the SwiftPro device.
2026-06-08
Swiftips - Box of ten SwiftPro applicator Swiftips. Swiftips are provided as a single use, non-sterile disposable tip, which is connected to the SwiftPro device.
2026-06-08
swiftPro System - swiftPro System comprising of the swiftPro Handpiece, Charging Dock, Rechargeable Battery Pack, DC Power adaptors.
2026-06-08
Swift System - Swift Generator, Handpiece and Cable.
2026-06-08
swiftPro Charging Dock DC Power Adaptor - The swiftPro Charging Dock DC Power Adaptor is used to power the swiftPro Charging Dock.
2026-06-08
swiftPro System - swiftPro Handpiece and DC Adaptor.
2023-12-04
Swift® Applicator Tips - Box of Ten Swift® applicator tips. Swift® applicator tip is provided as a single use, non-sterile disposable tip, which is connected to the Swift® handpiece.
2019-01-17
Swift® Applicator Tip - Swift® applicator tip is provided as a single-use, non-sterile disposable tip, which is connected to the Swift® handpiece.
2019-01-17
Swift Applicator Handpiece - The Swift® applicator handpiece connects to the Swift® microwave generator via the Swift® interconnect cable.
2019-01-02
Swift® Interconnect Cable - The Swift® interconnect cable connects the Swift® handpiece with the Swift® microwave generator.
2019-01-02
Swift® Microwave Generator - The Swift® microwave generator is intended to be used with the Swift® applicator for the coagulation of soft tissue.
2019-01-02
swiftPro LRT Applicator Tip - Box of Ten swiftPro LRT Applicator Tips
2023-12-04
swiftPro LRT Applicator Tip - The swiftPro LRT applicator tip is provided as a single-use, non-sterile disposable tip, which is connected to the Swift® handpiece.
2023-12-04
swiftPro URT Applicator Tip - Box of Ten swiftPro URT Applicator Tips
2023-12-04
swiftPro URT Applicator Tip - The swiftPro URT applicator tip is provided as a single-use, non-sterile disposable tip, which is connected to the Swift® handpiece.
2023-12-04
swiftPro Cradle - The swiftPro Cradle is the stand for the swiftPro Hand-Held Microwave Generator when not in use.
2023-12-04
swiftPro DC power adaptor - The swiftPro DC power adaptor is used to power the swiftPro hand-held generator
2023-12-04
swiftPro Hand-Held Microwave Generator - The swiftPro Hand-Held microwave generator is intended to be used with the swiftPro applicator tip for the coagulation of soft tissue.
2023-12-04
swiftPro Battery Power System - SWF-BPS01
2024-06-26
swiftPro Charging Dock - The swiftPro Charging dock
2024-06-26
swiftPro Battery Pack - The battery pack for the swiftPro Hand-held Microwave Generator
2024-06-26