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510(k) K241107

Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9) by Indiba S. A. U. — Product Code PBX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2025
Date Received
April 22, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Vacuum, Radio Frequency Induced Heat
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

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 clearances by Indiba S. A. U.

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  • K243164 — INDIBA COMPACT devices (November 20, 2024)

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  • K250916 — WinForth (LM-E470KA) (August 14, 2025)
  • K243716 — Zionic Pro Max (Radiofrequency) (May 28, 2025)
  • K241733 — HEBE (NP0000763) (April 16, 2025)
  • K243055 — Préime DermaFacial Collagen+ (April 15, 2025)
  • K242175 — XOD Diathermia Radiofrequency Device (February 27, 2025)
  • K232966 — FISIOWARM 7.0 (December 26, 2024)
  • K242553 — MIRARI® Cold Plasma System ( GV-M2-01) (November 21, 2024)