Class Class II
Pollogen STOP U Model UXV Device (K220322)
Description
Pollogen STOP U Model UXV Device by Pollogen, Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK220322
Clearance Date2023-05-04
Clearance TypeTraditional
Product CodePAY
Regulation Number878.4420
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K220322
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. Pollogen STOP U Model UXV Device (K220322) cites 1 predicate device and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203665 | STOP U Model UXV Device | Pollogen, Ltd. | 2021 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233766 | Geneo X Elite | Pollogen, Ltd. | 2024 |
| K232424 | CurrentBody Skin RF | El Global Trade, Ltd. | 2024 |
Trace the full predicate network for K220322
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.