# Nu Eyne Co., Ltd.

- Location (FDA's records): Seoul, KR
- FDA decisions: 5 (2019–2025): 5 510(k) clearances
- Product codes: PCC (3), QGL (2)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 2 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cefaly Technology: 2 (https://510kreport.com/company/cefaly-technology)
- Neurosigma, Inc.: 1 (https://510kreport.com/company/neurosigma)

## Its most-cited devices
- K211380: Elexir (2021), cited by 1
- K213629: SMILE (2023), cited by 1

## Recent decisions
- K243289: Addnox (BPSPM1) (Jan 16, 2025)
- K242719: Elexir 2.0 (ALLIVE3) (Nov 6, 2024)
- K213629: SMILE (Feb 12, 2023)
- K211380: Elexir (Jul 30, 2021)
- K192773: Allive (Dec 6, 2019)

Source page: https://510kreport.com/company/nu-eyne