Class Class II
Renuvion® APR Handpiece (K223262)
Description
Renuvion® APR Handpiece by Apyx Medical Corporation, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223262
Clearance Date2023-02-23
Clearance TypeTraditional
Product CodeGEI
Regulation Number878.4400
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223262
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. Renuvion® APR Handpiece (K223262) cites 2 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220970 | Renuvion APR Handpiece | Apyx Medical Corporation(Formerly B... | 2022 |
| K202558 | Ellusa Bipolar Wands | Ellusa, LLC | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230586 | Renuvion® Micro Handpiece | Apyx Medical Corporation | 2023 |
| K230272 | Renuvion® APR Handpiece | Apyx Medical Corporation | 2023 |
Trace the full predicate network for K223262
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.