# K242719: Elexir 2.0 (ALLIVE3)

- Pathway: 510(k) (Traditional)
- Applicant: Nu Eyne Co., Ltd.
- Decided: Nov 6, 2024 after 57 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: 5 generations back to DEN120019 (2014). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211380: Elexir, Nu Eyne Co., Ltd. (2021) Summary page 6.

## Indications for use
The ELEXIR 2.0 is indicated for the acute treatment of migraine (Acute mode, frequency 100 Hz) and the prophylactic treatment of episodic migraine (Prevention mode, frequency 60 Hz) in patients 18 years of age or older.

Source page: https://510kreport.com/device/K242719
Methodology: https://510kreport.com/methodology