Cleared Traditional

K160329 - InMode System MiniFX Handpiece

K160329 is an FDA 510(k) clearance for InMode System MiniFX Handpiece, manufactured by Inmode MD , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code PBX cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K160329 · Inmode MD , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
196d
Days
Class 2
Risk

K160329 is an FDA 510(k) clearance for the InMode System MiniFX Handpiece. Classified as Massager, Vacuum, Radio Frequency Induced Heat (product code PBX), Class II - Special Controls.

Submitted by Inmode MD , Ltd. (Yokneam, IL). The FDA issued a Cleared decision on August 19, 2016 after a review of 196 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 Inmode MD , Ltd. devices

FDA 510(k) Submission Details - K160329

510(k) Number K160329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2016
Decision Date August 19, 2016
Days to Decision 196 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
81d slower than avg
Panel avg: 115d · This submission: 196d
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 , 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 79
Devices cleared under the same product code (PBX) and FDA review panel - the closest regulatory comparables to K160329.
Indiba Diathermia Radiofrequency Device - Activ
K161458 · Indiba USA, Inc. · Oct 2016
TR-100
K161551 · BTL Industries, Inc. · Sep 2016
Profound System
K161043 · Syneron Candela Corporation · Sep 2016
EndyMed Contour Handpiece
K161199 · Endymed Medical, Ltd. · Aug 2016
InMode Plus System
K153568 · Inmode MD , Ltd. · Jul 2016
Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)
K151296 · Bios S.R.L. · Nov 2015