# K222260: Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500

- Pathway: 510(k) (Abbreviated)
- Applicant: Capenergy Medical S.L.
- Decided: Mar 28, 2023 after 243 days
- Product code: PBX (Massager, Vacuum, Radio Frequency Induced Heat)
- 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: 19 generations back to K943450 (1995). 111 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 115 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191202: Capenergy - C100, C200, C300, C400, C50, Capenergy Medical S.L. (2020) Summary page 4.
- K171094: Thermi Reusable Non-invasive RF Electrode, Thermgen, L.L.C (2017) Summary page 4.

## Most influential descendants
- K241832: Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System (Unicorn+ II); Unicorn+ RF System (Unicorn+ III) (2025), 1 descendant of its own
- K253480: Capenergy C Equipments RF C200 and C400 Drakarian (2026), 0 descendants of its own
- K254290: ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III) (2026), 0 descendants of its own

## Indications for use
Capenergy C equipments RF System - C25, C50, C100, C200, C300, C400, C500 are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation, and dermatological procedures. The massage device provided is intended to provide a temporary reduction in the appearance of cellulite. Capenergy C equipments RF System - C25, C50, C100, C200, C300, C400, C500 are indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

Source page: https://510kreport.com/device/K222260
Methodology: https://510kreport.com/methodology