Company ยท KR
Nu Eyne Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2025. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 16, 2025 | K243289 | ADDNOX (BPSPM1) Nu Eyne Co., Ltd., KR | QGL |
| Nov 6, 2024 | K242719 | ELEXIR 2.0 (ALLIVE3) Nu Eyne Co., Ltd., KR | PCC |
| Feb 12, 2023 | K213629 | SMILE Nu Eyne Co., Ltd., KR | QGL |
| Jul 30, 2021 | K211380 | Elexir Nu Eyne Co., Ltd., KR | PCC |
| Dec 6, 2019 | K192773 | ALLIVE Nu Eyne Co., Ltd., KR | PCC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||