Class Class II
Eneka Pro (K223680)
Description
Eneka Pro by Termosalud, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223680
Clearance Date2023-02-10
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223680
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. Eneka Pro (K223680) cites 1 predicate device and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K191321 | Primelase Excellence | High Technology Products S.L.U | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242951 | Diode laser hair removal machine (QDTM-02) | Beijing Nubway S&T Co., Ltd. | 2025 |
| K241656 | Eneka Selectif | Termosalud | 2024 |
Trace the full predicate network for K223680
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.