Class Class II
Plasma IQ (K223222)
Description
Plasma IQ by Neauvia North America, Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223222
Clearance Date2023-01-17
Clearance TypeSpecial
Product CodeGEI
Regulation Number878.4400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223222
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. Plasma IQ (K223222) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212329 | Plasma IQ | Neauvia North America, Inc. | 2021 |
| K201738 | SubNovii Advanced Plasma Technology | Cartessa Aesthetics | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241099 | Plasonic (Plasonic) | Hironic Co., Ltd. | 2024 |
Trace the full predicate network for K223222
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.