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510(k) K243164

INDIBA COMPACT devices by Indiba S. A. U. — Product Code PBX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2024
Date Received
September 30, 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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  • K243139 — Reverso Pro System (January 22, 2025)

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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)
  • K241107 — Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); I (January 24, 2025)
  • K232966 — FISIOWARM 7.0 (December 26, 2024)