Capenergy C Equipments RF C200 and C400 Drakarian— 510(k) K253480
Substantially EquivalentCapenergy Medical S.L.
FDA 510(k) clearance K253480 for Capenergy C Equipments RF C200 and C400 Drakarian, Substantially Equivalent on 2026-07-10. Applicant: Capenergy Medical S.L.. Device class: 2.
Summary
Capenergy Medical's clearance is titled "Capenergy C Equipments RF C200 and C400 Drakarian" and is filed under PBX, vacuum massagers with radio frequency induced heat. The record doesn't say how the C200 and C400 differ.
Class II, 21 CFR 878.4400. General and Plastic Surgery is both the classification panel and the review panel, and it came in as an Abbreviated 510(k).
Capenergy filed from Sant Joan Despi, Spain. The decision came 269 calendar days after FDA received it (October 14, 2025 to July 10, 2026).
Clearance details
- Applicant
- Capenergy Medical S.L.
- Product code
- Product code PBX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Sant Joan Despi, ES
Recent devices under product code PBX
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