# K212947: Trinity Plus Wrinkle Reducer

- Pathway: 510(k) (Traditional)
- Applicant: Carol Cole Company Dba Nuface
- Decided: Apr 2, 2022 after 199 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K101190 (2010). 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)
- K120560: Trinity Wrinkle Remover, Carol Cole Company (2012) Summary page 4.
- K172662: reVive Perioral, Led Technologies, Inc. (2018) Summary page 4.

## Indications for use
The Trinity Plus Wrinkle Reducer is an over-the-counter hand-held device intended for reduction of full-face fine lines and wrinkles, and increase in local circulation within the perioral region.

Source page: https://510kreport.com/device/K212947
Methodology: https://510kreport.com/methodology