# K213629: SMILE

- Pathway: 510(k) (Traditional)
- Applicant: Nu Eyne Co., Ltd.
- Decided: Feb 12, 2023 after 452 days
- Product code: QGL (Transcutaneous Nerve Stimulator For Adhd)
- Device class: 2
- Regulation: 21 CFR 882.5898
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN180041 (2019). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180041: Monarch eTNS System, Neurosigma, Inc. (2019) Summary page 4.

## Most influential descendants
- K243289: Addnox (BPSPM1) (2025), 0 descendants of its own

## Indications for use
The SMILE external Trigeminal Nerve Stimulation (eTNS) System is indicated for treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is to be used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.

Source page: https://510kreport.com/device/K213629
Methodology: https://510kreport.com/methodology