Class Class II
Leonardo Duster (K250504)
Description
Leonardo Duster by Ceramoptec GmbH, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250504
Clearance Date2025-07-14
Clearance TypeAbbreviated
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250504
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. Leonardo Duster (K250504) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242191 | SOLTIVEĀ Laser System (SOLTIVEĀ Pro SuperPulsed Laser, SOLT... | Olympus Surgical Technologies America | 2024 |
Trace the full predicate network for K250504
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.