Class Class II
Optimas MAX System (K251632)
Description
Optimas MAX System by Inmode , Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251632
Clearance Date2025-06-26
Clearance TypeSpecial
Product CodeGEX
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251632
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. Optimas MAX System (K251632) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231790 | The InMode System with the Morpheus8 Applicators | InMode , Ltd. | 2023 |
| K221571 | InMode Multi-system | InMode , Ltd. | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K252215 | InbellaMAX System | Inbella Medical , Ltd. | 2025 |
Trace the full predicate network for K251632
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.