Cleared Traditional

K241107 - Indiba Diathermia Radiofrequency Deep C...

Also marketed or referenced as:
Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9)

K241107 is an FDA 510(k) clearance for Indiba Diathermia Radiofrequency Deep C..., manufactured by Indiba S. A. U.. The device is a Class 2 General & Plastic Surgery device with product code PBX cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K241107 · Indiba S. A. U. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2025
Decision
277d
Days
Class 2
Risk

K241107 is an FDA 510(k) clearance for the Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ). Classified as Massager, Vacuum, Radio Frequency Induced Heat (product code PBX), Class II - Special Controls.

Submitted by Indiba S. A. U. (Sant Quirze Del Vallès (Barcelona), ES). The FDA issued a Cleared decision on January 24, 2025 after a review of 277 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Indiba S. A. U. devices

FDA 510(k) Submission Details - K241107

510(k) Number K241107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2024
Decision Date January 24, 2025
Days to Decision 277 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 115d · This submission: 277d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PBX Device Classification - Class 2, Special Controls

Product Code PBX Massager, Vacuum, Radio Frequency Induced Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

A. Stein Regulatory Affairs Consulting Company , Ltd.
Amit Goren

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PBX Massager, Vacuum, Radio Frequency Induced Heat

All 65
Devices cleared under the same product code (PBX) and FDA review panel - the closest regulatory comparables to K241107.
HEBE (NP0000763)
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Préime DermaFacial Collagen+
K243055 · EMA Aesthetics , Ltd. · Apr 2025
XOD Diathermia Radiofrequency Device
K242175 · Xod, Inc. · Feb 2025
FISIOWARM 7.0
K232966 · Golden Star Srl · Dec 2024
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K242553 · General Vibronics, Inc. · Nov 2024
INDIBA COMPACT devices
K243164 · Indiba S. A. U. · Nov 2024