Class Class II
Edison System (K241902)
Description
Edison System by HistoSonics, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241902
Clearance Date2024-10-30
Clearance TypeTraditional
Product CodeQGM
Regulation Number878.4405
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241902
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. Edison System (K241902) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233466 | Edison System | HistoSonics, Inc. | 2024 |
| K231989 | LOGIQ E10s, LOGIQ Fortis | Ge Medical Systems Ultrasound and P... | 2023 |
Trace the full predicate network for K241902
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.