Medical Device Manufacturer · KR , Seoul

Nu Eyne Co., Ltd. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2019
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Nu Eyne Co., Ltd. Neurology ✕
5 devices
1-5 of 5
Cleared Jan 16, 2025
ADDNOX (BPSPM1)
K243289 · QGL
Neurology · 90d
Cleared Nov 06, 2024
ELEXIR 2.0 (ALLIVE3)
K242719 · PCC
Neurology · 57d
Cleared Feb 12, 2023
SMILE
K213629 · QGL
Neurology · 452d
Cleared Jul 30, 2021
Elexir
K211380 · PCC
Neurology · 87d
Cleared Dec 06, 2019
ALLIVE
K192773 · PCC
Neurology · 67d
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