# K171821: 2 Face / Face Evolution

- Pathway: 510(k) (Traditional)
- Applicant: Heat IN A Click
- Decided: Apr 26, 2018 after 311 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: 14 generations back to K943450 (1995). 153 ancestors in all.
58 later devices descend from it; 9 cite it directly.
0 of 212 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 5.
- K162098: LED Phototherapy Device, Li-Tek Electronic Technology Corporation (2017) Summary page 5.

## Most influential descendants
- K212155: TheraFace LED (2021), 42 descendants of its own
- K223544: LED light therapy mask (FM-01, FM-02, FM-03) (2023), 39 descendants of its own
- K241857: LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) (2024), 21 descendants of its own
- K241718: Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) (2024), 12 descendants of its own
- K242700: Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) (2024), 6 descendants of its own

## Indications for use
2 Face / Face Evolution is a hand-held device for over-the counter aesthetic purposes. (1) The EMS mode is indicated for facial stimulation; (2) The Photon mode: The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K171821
Methodology: https://510kreport.com/methodology