Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ) +1 more— 510(k) K241107

Name: FDA 510(k) clearance K241107
Creator: U.S. Food and Drug Administration
Published: 2025-01-24

Substantially Equivalent

Indiba S. A. U.

FDA 510(k) clearance K241107 for Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ) +1 more, Substantially Equivalent on 2025-01-24. Applicant: Indiba S. A. U.. Device class: 2.

Clearance details

Device name as filed: Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9)
Applicant: Indiba S. A. U.
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2024-04-22
Decision date: 2025-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sant Quirze Del Vallès (Barcelona), ES

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.