# K201782: NuFace Trinity Plus Device

- Pathway: 510(k) (Traditional)
- Applicant: Carol Cole Company Dba Nuface
- Decided: Jan 22, 2021 after 206 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). 5 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 11 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 4.

## Most influential descendants
- K212342: ZIIP+ Device (2021), 2 descendants of its own
- K243587: PureLift GLOW (2025), 1 descendant of its own
- K261370: LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) (2026), 0 descendants of its own
- K232863: Radiant Renewal Skincare Wand (HD-15, HD-15A) (2023), 0 descendants of its own
- K213078: Myolift QT (2023), 0 descendants of its own

## Indications for use
The NUFACE® Trinity Plus Device is intended for facial and neck stimulation and is indicated for over-the counter cosmetic use.

Source page: https://510kreport.com/device/K201782
Methodology: https://510kreport.com/methodology