Class Class II
Reverso Pro System (K243139)
Description
Reverso Pro System by Indiba S. A. U., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243139
Clearance Date2025-01-22
Clearance TypeTraditional
Product CodeGEI
Regulation Number878.4400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243139
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. Reverso Pro System (K243139) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212107 | Reverso | Intelis Instruments , Ltd. | 2021 |
| K201164 | Venus Viva MD Device | Venus Concept USA, Inc. | 2020 |
| K172302 | InMode PLUS System | Inmode MD , Ltd. | 2017 |
Trace the full predicate network for K243139
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.