EMPOWER ENVISION AG609482A

GUDID 07290016633665

InMode RF system

INMODE M.D LTD

Radio-frequency ablation system generator
Primary Device ID07290016633665
NIH Device Record Keya7e5ed4e-c7e6-4abe-846a-ef05f29f8feb
Commercial Distribution StatusIn Commercial Distribution
Brand NameEMPOWER ENVISION
Version Model NumberInMode RF PRO
Catalog NumberAG609482A
Company DUNS600417351
Company NameINMODE M.D LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18873674556
Emailcontact@inmode.com
Phone18873674556
Emailcontact@inmode.com
Phone18873674556
Emailcontact@inmode.com
Phone18873674556
Emailcontact@inmode.com
Phone18873674556
Emailcontact@inmode.com
Phone18873674556
Emailcontact@inmode.com
Phone18873674556
Emailcontact@inmode.com
Phone18873674556
Emailcontact@inmode.com
Phone18873674556
Emailcontact@inmode.com
Phone18873674556
Emailcontact@inmode.com
Phone18873674556
Emailcontact@inmode.com
Phone18873674556
Emailcontact@inmode.com
Phone18873674556
Emailcontact@inmode.com
Phone18873674556
Emailcontact@inmode.com
Phone18873674556
Emailcontact@inmode.com
Phone18873674556
Emailcontact@inmode.com
Phone18873674556
Emailcontact@inmode.com
Phone18873674556
Emailcontact@inmode.com
Phone18873674556
Emailcontact@inmode.com
Phone18873674556
Emailcontact@inmode.com
Phone18873674556
Emailcontact@inmode.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016633665 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-23
Device Publish Date2021-07-15

Devices Manufactured by INMODE M.D LTD

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07290016633368 - BodyTite Pro2024-05-27 The lnMode RF System generating RF energy with integral temperature and impedance feedback mechanism for procedures requiring el
07290016633955 - Lumecca I2024-05-24 Lumecca I
07290019863045 - InMode RF hand piece2024-05-03 Handpiece comprises internal active electrode, external return electrode, both with temperature sensor, handle, cable and connec
07290019863052 - InMode RF hand piece2024-05-03 Handpiece comprises internal active electrode, external return electrode, both with temperature sensor, handle, cable and connec
07290016633726 - Envision System2024-04-01 The Envision Platform with Forma-I, Forma, Morpheus8 and Lumecca Applicators employs two different technologies for various aest
07290019863021 - Morpheus8C Handpiece2024-04-01 Morpheus8C Handpiece is intended for use in dermatologic procedures for electrocoagulation and hemostasis.

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