Class Class II
ADDNOX (BPSPM1) (K243289)
Description
ADDNOX (BPSPM1) by Nu Eyne Co., Ltd., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243289
Clearance Date2025-01-16
Clearance TypeTraditional
Product CodeQGL
Regulation Number882.5898
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243289
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. ADDNOX (BPSPM1) (K243289) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213629 | SMILE | Nu Eyne Co., Ltd. | 2023 |
Trace the full predicate network for K243289
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.