Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

InMode System with Fractora3D/3D-90 Applicators

K-Number: K180189 · 2018-06-01

ApplicantInmode MD , Ltd.
Decision Date2018-06-01
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

InMode System with Fractora3D/3D-90 Applicators is the device name listed in this FDA 510(k) record. The listed applicant is Inmode MD , Ltd.. It received FDA 510(k) clearance on 2018-06-01 under 510(k) number K180189. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InMode System with Fractora3D/3D-90 Applicators?

InMode System with Fractora3D/3D-90 Applicators is a medical device that received FDA 510(k) clearance on 2018-06-01. The listed applicant is Inmode MD , Ltd.. The 510(k) number is K180189.

When did InMode System with Fractora3D/3D-90 Applicators receive FDA 510(k) clearance?

InMode System with Fractora3D/3D-90 Applicators received FDA 510(k) clearance on 2018-06-01, under 510(k) number K180189.

Who is the listed applicant for InMode System with Fractora3D/3D-90 Applicators?

The FDA 510(k) record lists Inmode MD , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InMode System with Fractora3D/3D-90 Applicators?

The FDA product code for InMode System with Fractora3D/3D-90 Applicators is GEI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06283056RF Microneedling With Multi-Depth Targeting Per Insertion for The Treatment of CelluliteCOMPLETED

Other records listing Inmode MD , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K210492InMode RF Pro SystemK192695InMode System with the Morpheus8 (Fractora) ApplicatorsK191855EmFace DeviceK183450EmBody SystemK182325InMode RF SystemK180719InMode Diolaze System

View all 16 devices →

Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbHK253504Volnewmer™Classys, Inc.K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)Olympus Medical Systems Corp.K253484LUTRONIC GENIUSCynosure Lutronic Technology CorporationK251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑