Capenergy C Equipments RF C200 and C400 Drakarian— 510(k) K253480

Name: FDA 510(k) clearance K253480
Creator: U.S. Food and Drug Administration
Published: 2026-07-10

Substantially Equivalent

Capenergy 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.

Clearance details

Applicant: Capenergy Medical S.L.
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2025-10-14
Decision date: 2026-07-10
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Sant Joan Despi, ES

Download summary PDF View on FDA.gov ↗

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