Class Class II
DENSITY; DENZA; DENSITY Noir (K250065)
Description
DENSITY; DENZA; DENSITY Noir by Jeisys Medical Incorporated, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250065
Clearance Date2025-07-08
Clearance TypeTraditional
Product CodeGEI
Regulation Number878.4400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250065
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. DENSITY; DENZA; DENSITY Noir (K250065) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230663 | Density | Jeisys Medical, Inc. | 2023 |
Trace the full predicate network for K250065
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.