# K220124: YandR System, VoluDerm Handpiece, VoluDerm Tips

- Pathway: 510(k) (Special)
- Applicant: Pollogen, Ltd.
- Decided: Feb 17, 2022 after 30 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: 20 generations back to K943450 (1995). 259 ancestors in all.
No later device cites it as a predicate yet.
0 of 260 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173503: Pollogen Legend System, Pollogen, Ltd. (2018) Summary page 4.

## Indications for use
The YandR System is intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Handpiece.

Source page: https://510kreport.com/device/K220124
Methodology: https://510kreport.com/methodology