InMode OP AG605893A

GUDID 07290019863311

The InMode OP System is employing three different technologies for various aesthetic applications – Laser, Intense Pulsed Light (IPL), and Radiofrequency (RF).

INMODE M.D LTD

Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system

Primary Device ID	07290019863311
NIH Device Record Key	a7bd6c29-ce1b-4848-86f5-a189725e7b13
Commercial Distribution Status	In Commercial Distribution
Brand Name	InMode OP
Version Model Number	AG605893A
Catalog Number	AG605893A
Company DUNS	600417351
Company Name	INMODE M.D LTD
Device Count	1
DM Exempt	true
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

Operating and Storage Conditions

Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 110 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 90 KiloPascal and 110 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 110 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 90 KiloPascal and 110 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 110 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 90 KiloPascal and 110 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 110 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 90 KiloPascal and 110 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 110 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 90 KiloPascal and 110 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 110 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 90 KiloPascal and 110 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 110 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 90 KiloPascal and 110 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 110 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 90 KiloPascal and 110 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 110 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 90 KiloPascal and 110 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 110 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 90 KiloPascal and 110 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 110 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 90 KiloPascal and 110 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 110 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 65 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 90 KiloPascal and 110 KiloPascal
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019863311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K221571

FDA Product Code

GEX	Powered Laser Surgical Instrument

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-04-01
Device Publish Date	2024-03-24

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