# K211380: Elexir

- Pathway: 510(k) (Traditional)
- Applicant: Nu Eyne Co., Ltd.
- Decided: Jul 30, 2021 after 87 days
- Product code: PCC (Stimulator, Nerve, Electrical, Transcutaneous, For Migraine)
- Device class: 2
- Regulation: 21 CFR 882.5891
- 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 DEN120019 (2014). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173006: Cefaly Dual, Cefaly Technology (2017) Summary page 4.

## Most influential descendants
- K242719: Elexir 2.0 (ALLIVE3) (2024), 0 descendants of its own

## Indications for use
THE ELEXIR is indicated for the acute treatment of migraine (program 1) and the prophylactic treatment of episodic migraine (Program 2) in patients 18 years of age or older

Source page: https://510kreport.com/device/K211380
Methodology: https://510kreport.com/methodology