Class Class II
Erchonia Zerona® VZ8 (K243811)
Description
Erchonia Zerona® VZ8 by Erchonia Corporation, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243811
Clearance Date2025-01-10
Clearance TypeTraditional
Product CodeOLI
Regulation Number878.5400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243811
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. Erchonia Zerona® VZ8 (K243811) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231474 | Erchonia Violet ZERONA® Z6 OTC | Erchonia Corporation | 2023 |
| K192544 | Erchonia Emerald | Erchonia Corporation | 2020 |
Trace the full predicate network for K243811
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.