# K211652: Renuvion Dermal Handpiece, Renuvion Dermal System

- Pathway: 510(k) (Traditional)
- Applicant: Apyx Medical Corporation (Formerly Bovie Medical Corporation
- Decided: May 25, 2022 after 362 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K943450 (1995). 149 ancestors in all.
No later device cites it as a predicate yet.
0 of 150 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132754: Neogen PSR System, Energist, Ltd. (2013) Summary page 4.

## Indications for use
The Renuvion® Dermal System is an electrosurgical device for dermatological procedures for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II or III. The treatment is achieved through controlled heating of the outer layers of the skin so that part or all of the epidermis becomes non-viable and there is controlled thermal modification to the underlying dermis. The Renuvion® Dermal Handpiece is only compatible with Apyx Medical Electrosurgical Generators.

Source page: https://510kreport.com/device/K211652
Methodology: https://510kreport.com/methodology