Cleared Special

K163190 - InMode RF System

K163190 is an FDA 510(k) clearance for InMode RF System, manufactured by Inmode MD , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 28-day FDA review.

K163190 · Inmode MD , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
28d
Days
Class 2
Risk

K163190 is an FDA 510(k) clearance for the InMode RF System. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Inmode MD , Ltd. (Yokneam, IL). The FDA issued a Cleared decision on December 12, 2016 after a review of 28 days - a notably fast clearance 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Inmode MD , Ltd. devices

FDA 510(k) Submission Details - K163190

510(k) Number K163190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2016
Decision Date December 12, 2016
Days to Decision 28 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1267
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K163190.
ENSEAL X1 Large Jaw Tissue Sealer
K163548 · Ethicon Endo-Surgery, LLC · Feb 2017
OsteoCool V-3 RF Ablation System
K161949 · Baylis Medical Company, Inc. · Jan 2017
Barrx Anorectal RFA Wand
K162802 · Covidien, LLC · Jan 2017
PK AIM
K163373 · Gyrus Acmi, Inc. · Dec 2016
Voyant Open Fusion Device
K162676 · Applied Medical Resources · Dec 2016
CODMAN Integrated Bipolar Cord and Tubing Set
K163106 · Medos International SARL · Dec 2016