# K171588: NuBODY Skin Toning Device

- Pathway: 510(k) (Traditional)
- Applicant: Carol Cole Company Dba Nuface
- Decided: Jul 31, 2017 after 61 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.
17 later devices descend from it; 4 cite it directly.
0 of 22 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
- K243430: Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) (2024), 3 descendants of its own
- K252146: Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) (2025), 1 descendant of its own
- K250227: JOVS Electric Stimulation Beauty Device (JE2) (2025), 1 descendant of its own

## Indications for use
NuBODY Skin Toning Device is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.

Source page: https://510kreport.com/device/K171588
Methodology: https://510kreport.com/methodology