EMPOWER ENVISION AG609482A

GUDID 07290016633665

Radio-frequency ablation system generator

Primary Device ID	07290016633665
NIH Device Record Key	a7e5ed4e-c7e6-4abe-846a-ef05f29f8feb
Commercial Distribution Status	In Commercial Distribution
Brand Name	EMPOWER ENVISION
Version Model Number	InMode RF PRO
Catalog Number	AG609482A
Company DUNS	600417351
Company Name	INMODE M.D LTD
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	07290016633665 [Primary]

GEI	Electrosurgical, Cutting & Coagulation & Accessories

Steralize Prior To Use	false
Device Is Sterile	false

07290019863267 - Luxora System	2025-08-19 The Luxora™ device is based on the InMode RF Pro™ platform. The Luxora system employs radiofrequency (RF) energy for use in
07290016633313 - Plus Applicator	2025-08-04 Plus (Plus Plus)
07290019863359 - ApexRF Applicator	2025-06-12 ApexRF handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, and te
07290019863274 - InMode RF hand piece	2025-02-28 AccuTite HP 2 Pack black
07290019863281 - InMode RF hand piece	2025-02-28 FaceTite 2-Pack black
07290019863298 - InMode RF hand piece	2025-02-28 InModeRF HP 17x22x46 black
07290019863342 - APEX RF System	2025-01-17 Apex RF system employs radiofrequency (RF) energy for use in dermatological procedures.
07290016633573 - Define System	2025-01-15 The DEFINE System is designed to deliver non-thermal RF energy to the skin and subdermal fat. .