Cleared Traditional

K153568 - InMode Plus System

K153568 is an FDA 510(k) clearance for InMode Plus System, 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 211-day FDA review.

K153568 · Inmode MD , Ltd. · General & Plastic Surgery device
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Jul 2016
Decision
211d
Days
Class 2
Risk

K153568 is an FDA 510(k) clearance for the InMode Plus System. 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 July 12, 2016 after a review of 211 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 - K153568

510(k) Number K153568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2015
Decision Date July 12, 2016
Days to Decision 211 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 115d · This submission: 211d
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 Peers - PBX Massager, Vacuum, Radio Frequency Induced Heat

All 66
Devices cleared under the same product code (PBX) and FDA review panel - the closest regulatory comparables to K153568.
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XP3000
K150720 · BTL Industries, Inc. · Sep 2015
Exilis XP
K143040 · BTL Industries, Inc. · Jan 2015
TRUSCULPT
K133739 · Cutera, Inc. · Sep 2014