Cleared Traditional

K241107 - Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ) (FDA 510(k) Clearance)

Also includes:
Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
163d slower than avg
Panel avg: 114d · This submission: 277d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

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