# K250361: SmartAppGuidedTM MicroCurrent Face-Lift Pen  6 in 1

- Pathway: 510(k) (Traditional)
- Applicant: Geske Beauty Tech GmbH
- Decided: May 23, 2025 after 102 days
- Product code: NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K011935 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181008: NuFACE Trinity, Carol Cole Company Dba Nuface (2018) Summary page 5.
- K171588: NuBODY Skin Toning Device, Carol Cole Company Dba Nuface (2017) Summary page 5.
- K221443: PureLift Pro Plus, Xtreem Pulse, LLC (2022) Summary page 5.

## Indications for use
SmartAppGuidedT M MicroCurrent Face-Lift Pen I 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.

Source page: https://510kreport.com/device/K250361
Methodology: https://510kreport.com/methodology