Smile

FDA 510(k) K213629 · Nu Eyne Co., Ltd.

Substantially Equivalent

510(k) numberK213629

Submission

Device name
Smile
Applicant
Nu Eyne Co., Ltd.
Seoul, KR
Received
November 17, 2021
Decision date
February 12, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QGL – Transcutaneous Nerve Stimulator For Adhd
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5898
Specialty
Neurology

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.

Other 510(k)s with product code QGL

510(k)DeviceApplicantDecision
K243289Addnox (BPSPM1)QGL · Traditional Nu Eyne Co., Ltd.01/16/2025SE
K232991BT-1000QGL · Traditional Bistos Co., Ltd.08/28/2024SE
K233293Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®QGL · Traditional Neurosigma, Inc.01/16/2024SE

More from Neurosigma, Inc.

510(k)DeviceDecision
K243289Addnox (BPSPM1)QGL · Traditional 01/16/2025SE
K242719Elexir 2.0 (ALLIVE3)PCC · Traditional 11/06/2024SE
K211380ElexirPCC · Traditional 07/30/2021SE
K192773AllivePCC · Traditional 12/06/2019SE

Questions and answers

When was Smile cleared by the FDA?

Smile (K213629) received a 510(k) decision of Substantially Equivalent on February 12, 2023, 452 days after the submission was received.

What is the product code of K213629?

The FDA product code is QGL – Transcutaneous Nerve Stimulator For Adhd, a Class II (moderate risk) device regulated under 21 CFR 882.5898.