K241107
- 510(k) number
- K241107
- Device name
- Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9)
- Applicant
- Indiba S. A. U. ES
- Product code
- PBX — Massager, Vacuum, Radio Frequency Induced Heat
- Decision date
- 2025-01-24
- Date received
- 2024-04-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.0 MB · U.S. public domain
Also available from FDA: K241107.pdf
Official FDA record: K241107
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.