Cleared Traditional

ELEXIR 2.0 (ALLIVE3)

K242719 · Nu Eyne Co., Ltd. · Neurology

Nov 2024

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K242719 is an FDA 510(k) clearance for the ELEXIR 2.0 (ALLIVE3), a Stimulator, Nerve, Electrical, Transcutaneous, For Migraine (Class II — Special Controls, product code PCC), submitted by Nu Eyne Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on November 6, 2024, 57 days after receiving the submission on September 10, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5891.

Submission Details

510(k) Number	K242719 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 2024
Decision Date	November 06, 2024
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	PCC — Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5891
Definition	Used To Apply An Electrical Current To A Patient's Cranium Through Electrodes Placed On The Skin.