Cleared Traditional

Elexir

K211380 · Nu Eyne Co., Ltd. · Neurology

Jul 2021

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K211380 is an FDA 510(k) clearance for the Elexir, 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 July 30, 2021, 87 days after receiving the submission on May 4, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5891.

Submission Details

510(k) Number	K211380 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 04, 2021
Decision Date	July 30, 2021
Days to Decision	87 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.