# K131251: Trinity Ele

- Pathway: 510(k) (Traditional)
- Applicant: Carol Cole Company
- Decided: Oct 1, 2013 after 153 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.
13 later devices descend from it; 2 cite it directly.
0 of 18 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 1.

## Most influential descendants
- K201906: Trinity ELE Plus and Trinity ELE Plus Pro (2021), 10 descendants of its own
- K241102: Luna 4 plus (2024), 5 descendants of its own
- K213039: Micro-current facial cold and hot service (model: TPML-100) (2022), 4 descendants of its own
- K243423: LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB) (2025), 3 descendants of its own
- K243430: Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) (2024), 3 descendants of its own

## Indications for use
The Trinity ELE is intended for facial stimulation and is indicated for over-the-counter cosmetic use (21 CFR 807 Subpart C).

Source page: https://510kreport.com/device/K131251
Methodology: https://510kreport.com/methodology