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

07290019863083 - Morpheus8 Resurfacing TIP2024-08-30 Morpheus8 Resurfacing 24pin TIP
07290019863090 - Morpheus8 Prime 12 pin TIP2024-08-30 Morpheus8 Prime 12pin Tip
07290019863106 - Morpheus8 40 pin TIP2024-08-30 Morpheus8 - 40 Pin TIP
07290019863113 - Morpheus8 24 pin TIP2024-08-30 Morpheus8 - 24 Pin TIP
07290019863120 - Morpheus8 Burst Applicator2024-08-29 Morpheus8 Burst Applicator ( BLK)
07290019863137 - Morpheus8 Burst Deep Applicator2024-08-29 Morpheus8 Burst Deep Applicator (BLUE_BLK)
07290019863144 - Lumecca Peak2024-08-23 Lumecca Peak (Lumecca 515 BLK)
07290019863151 - Lumecca Peak2024-08-23 Lumecca Peak (Lumecca 580 BLK)

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