Capenergy C Equipments RF C200 and C400 Drakarian
FDA 510(k) K253480 · Capenergy Medical S.L.
510(k) numberK253480
Submission
- Device name
- Capenergy C Equipments RF C200 and C400 Drakarian
- Applicant
- Capenergy Medical S.L.
Sant Joan Despi, ES - Received
- October 14, 2025
- Decision date
- July 10, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PBX – Massager, Vacuum, Radio Frequency Induced Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.
Other 510(k)s with product code PBX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260647 | SpecchioPBX · Special | El.En S.P.A. | 04/02/2026SE |
| K253261 | Apollo Quattro (APQ-10M)PBX · Traditional | Weero Co., Ltd. | 03/13/2026SE |
| K252888 | NeoSculpt PlusPBX · Traditional | S&M Medical Co., Ltd. | 03/09/2026SE |
| K250734 | OptiLUV DevicePBX · Traditional | Pollogen, Ltd. | 09/10/2025SE |
| K250916 | WinForth (LM-E470KA)PBX · Traditional | Shenzhen Leaflife Technology Co., Ltd. | 08/14/2025SE |
| K243716 | Zionic Pro Max (Radiofrequency)PBX · Traditional | Termosalud S.L. | 05/28/2025SE |
| K241733 | Hebe (NP0000763)PBX · Traditional | Novasonix Technology S.L. | 04/16/2025SE |
| K243055 | Préime DermaFacial Collagen+PBX · Traditional | EMA Aesthetics , Ltd. | 04/15/2025SE |
| K242175 | XOD Diathermia Radiofrequency DevicePBX · Traditional | Xod, Inc. | 02/27/2025SE |
| K241107 | Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba…PBX · Traditional | Indiba S. A. U. | 01/24/2025SE |
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Questions and answers
When was Capenergy C Equipments RF C200 and C400 Drakarian cleared by the FDA?
Capenergy C Equipments RF C200 and C400 Drakarian (K253480) received a 510(k) decision of Substantially Equivalent on July 10, 2026, 269 days after the submission was received.
What is the product code of K253480?
The FDA product code is PBX – Massager, Vacuum, Radio Frequency Induced Heat, a Class II (moderate risk) device regulated under 21 CFR 878.4400.