# K181008: NuFACE Trinity

- Pathway: 510(k) (Traditional)
- Applicant: Carol Cole Company Dba Nuface
- Decided: Oct 11, 2018 after 177 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: 3 generations back to K011935 (2001). 4 ancestors in all.
22 later devices descend from it; 4 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103472: Nuface Plus, Carol Cole Company (2011) Summary page 4.

## Most influential descendants
- K191951: Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device (2021), 13 descendants of its own
- K233010: Beagank 4T Plus (2023), 10 descendants of its own
- K201782: NuFace Trinity Plus Device (2021), 5 descendants of its own
- K243430: Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) (2024), 3 descendants of its own
- K212342: ZIIP+ Device (2021), 2 descendants of its own

## Indications for use
The NuFACE Trinity is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.

Source page: https://510kreport.com/device/K181008
Methodology: https://510kreport.com/methodology