Class Class II
eCO2 3D (K244060)
Description
eCO2 3D by Lutronic Corporation, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK244060
Clearance Date2025-07-31
Clearance TypeTraditional
Product CodeONG
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K244060
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. eCO2 3D (K244060) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213557 | Finexel | SNJ Co., Ltd. | 2022 |
| K100610 | LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP I... | Lutronic Corporation | 2011 |
Trace the full predicate network for K244060
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.