Class Class II
OneRF Trigeminal Nerve Radiofrequency Probes (K251243)
Description
OneRF Trigeminal Nerve Radiofrequency Probes by Neuroone Medical Technologies Corp., an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251243
Clearance Date2025-08-15
Clearance TypeTraditional
Product CodeGXI
Regulation Number882.4725
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251243
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. OneRF Trigeminal Nerve Radiofrequency Probes (K251243) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231675 | OneRF Ablation System | Neuroone Medical Technologies Corp. | 2023 |
| K050084 | COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEM... | Cosman Medical, Inc. | 2005 |
Trace the full predicate network for K251243
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.