Company · IL

Inmode MD , Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2021. Name variants (Inc, Corp, punctuation) are merged.

21510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
GEI	Electrosurgical, Cutting & Coagulation & Accessories	9
GEX	Powered Laser Surgical Instrument	5
PBX	Massager, Vacuum, Radio Frequency Induced Heat	5
NUV	Massager, Vacuum, Light Induced Heating	1
ONF	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	1

Decided	510(k)	Device and applicant	Code
Jul 12, 2021	K210492	InMode RF Pro System Inmode MD , Ltd., IL	GEI
Dec 27, 2019	K192695	InMode System with the Morpheus8 (Fractora) Applicators Inmode MD , Ltd., IL	GEI
Oct 29, 2019	K191855	EmFace Device Inmode MD , Ltd., IL	PBX
Jun 20, 2019	K183450	EmBody System Inmode MD , Ltd., IL	PBX
Sep 26, 2018	K182325	InMode RF System Inmode MD , Ltd., IL	GEI
Jun 14, 2018	K180719	InMode Diolaze System Inmode MD , Ltd., IL	GEX
Jun 1, 2018	K180189	InMode System with Fractora3D/3D-90 Applicators Inmode MD , Ltd., IL	GEI
Feb 23, 2018	K173677	InMode VLaze Inmode MD , Ltd., IL	GEX
Dec 8, 2017	K172302	InMode PLUS System Inmode MD , Ltd., IL	PBX
Oct 10, 2017	K171593	InMode RF System Inmode MD , Ltd., IL	GEI
Aug 7, 2017	K170738	InMode Diolaze XL Inmode MD , Ltd., IL	GEX
Dec 12, 2016	K163190	InMode RF System Inmode MD , Ltd., IL	GEI
Aug 19, 2016	K160329	InMode System MiniFX Handpiece Inmode MD , Ltd., IL	PBX
Jul 12, 2016	K153568	InMode Plus System Inmode MD , Ltd., IL	PBX
Feb 19, 2016	K151793	InMode RF System Inmode MD , Ltd., IL	GEI
Jan 4, 2016	K151273	InMode FRF Applicator Inmode MD , Ltd., IL	GEI
Jan 13, 2015	K142952	InMode Diolaze Device Inmode MD , Ltd., IL	GEX
Dec 3, 2014	K140926	INMODE WMFACE DEVICE Inmode MD , Ltd., IL	GEI
Oct 8, 2013	K131362	INMODE WMBODY DEVICE Inmode MD , Ltd., IL	NUV
Apr 2, 2013	K123860	INMODE SR IPL DEVICE Inmode MD , Ltd., IL	ONF
Feb 27, 2013	K123682	INMODE HAIR REMOVAL (HR) DEVICE Inmode MD , Ltd., IL	GEX

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.