# K253480: Capenergy C Equipments RF C200 and C400 Drakarian

- Pathway: 510(k) (Abbreviated)
- Applicant: Capenergy Medical S.L.
- Decided: Jul 10, 2026 after 269 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: 20 generations back to K943450 (1995). 130 ancestors in all.
No later device cites it as a predicate yet.
0 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192224: BTL-899, Btl (2019) Summary page 5.
- K163415: SlimShape System, Syneron Medical, Ltd. (2017) Summary page 5.
- K222260: Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500, Capenergy Medical S.L. (2023) Summary page 5.

## Indications for use
The Capenergy C Equipments RF C200 and C400 Drakarian are intended to provide topical heating for the purpose of elevating tissue temperature for dermatological procedures. The massage device is intended to provide a temporary reduction in the appearance of Cellulite. They are indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The Capenergy C Equipments RF C200 and C400 Drakarian are indicated for using for non-invasive reduction of abdominal circumference associated with subcutaneous fat induced by lipolytic processes.

Source page: https://510kreport.com/device/K253480
Methodology: https://510kreport.com/methodology