Cleared Traditional

K213629 - SMILE
(FDA 510(k) Clearance)

K213629 · Nu Eyne Co., Ltd. · Neurology

Feb 2023

Decision

452d

Days

Class 2

Risk

K213629 is an FDA 510(k) clearance for the SMILE, a Transcutaneous Nerve Stimulator For Adhd (Class II — Special Controls, product code QGL), submitted by Nu Eyne Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on February 12, 2023, 452 days after receiving the submission on November 17, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5898.

Submission Details

510(k) Number	K213629 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 2021
Decision Date	February 12, 2023
Days to Decision	452 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	QGL — Transcutaneous Nerve Stimulator For Adhd
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5898
Definition	A Transcutaneous Electrical Nerve Stimulator For Attention Deficit Hyperactivity Disorder (adhd) Is A Prescription Device That Stimulates Transcutaneously Or Percutaneously Through Electrodes Placed On The Forehead.