SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K250361 FDA 510(k)
- FDA Product Code
- NFO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5890 FDA 510(k)
- Regulation Number
- 882.5890 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SmartAppGuided MicroCurrent Face-Lift Pen 6 in 1 is a transcutaneous electrical stimulator for aesthetic purposes. It utilizes MicroCurrent Face-Lift and SmartSonic Pulsation technologies to stimulate facial and neck muscles.
This device is supplied by Geske Beauty Tech GmbH and is FDA 510K cleared. It is intended for use in aesthetic applications and is classified as a Class II medical device.
Frequently asked questions
What is the SmartAppGuided MicroCurrent Face-Lift Pen 6 in 1 used for?
This device is a transcutaneous electrical stimulator designed for aesthetic purposes. It utilizes MicroCurrent Face-Lift and SmartSonic Pulsation technologies to stimulate facial and neck muscles, intended for cosmetic applications.
How is the SmartAppGuided MicroCurrent Face-Lift Pen supplied?
The device is supplied by Geske Beauty Tech GmbH. It is classified as a Class II medical device and is FDA 510K cleared for aesthetic applications, with the manufacturer located in Berlin, Germany.
Is the SmartAppGuided MicroCurrent Face-Lift Pen reusable or single-use?
The device data does not specify whether the SmartAppGuided MicroCurrent Face-Lift Pen is designed for single-use or multiple applications. Users should refer to the manufacturer's instructions for proper usage and maintenance guidelines.
What regulatory approvals does the SmartAppGuided MicroCurrent Face-Lift Pen have?
The device has received FDA 510K clearance with the K number K250361. It is classified as a Class II medical device and was determined to be substantially equivalent to other devices in its product code category NFO.
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: MicroCurrent Face-Lift Pen | 6 in 1 - GESKE, GESKE SmartAppGuided™ MicroCurrent Face-Lift Pen, 6 in 1 ... - Amazon, SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1, MicroCurrent Face-Lifter | 6 in 1 - GESKE
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250361 | Class II | Active |
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Manufacturer
- Manufacturer
- Geske Beauty Tech GmbH
Sources (1)
- FDA 510(k) K250361 24 fields · synced Oct 1, 2026