InMode AG606992A

GUDID 07290016633382

InMode System 2 - color 2 The InMode Diolaze XL System with the Diolaze XL 810nm Hand piece is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime.The InMode Diolaze XL System with the Diolaze XL 755/810nm & 810/1064nm Hand pieces is intended for hair removal.

INMODE M.D LTD

Multi-modality skin surface treatment system
Primary Device ID07290016633382
NIH Device Record Key2aa84bfe-eb82-42b7-9b38-06f8b2607e77
Commercial Distribution StatusIn Commercial Distribution
Brand NameInMode
Version Model NumberAG606992A
Catalog NumberAG606992A
Company DUNS600417351
Company NameINMODE M.D LTD
Device Count1
DM Exempttrue
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

Phone1-887-367-4556
Emailcontact@InMode.com
Phone1-887-367-4556
Emailcontact@InMode.com
Phone1-887-367-4556
Emailcontact@InMode.com
Phone1-887-367-4556
Emailcontact@InMode.com
Phone1-887-367-4556
Emailcontact@InMode.com
Phone1-887-367-4556
Emailcontact@InMode.com
Phone1-887-367-4556
Emailcontact@InMode.com
Phone1-887-367-4556
Emailcontact@InMode.com
Phone1-887-367-4556
Emailcontact@InMode.com
Phone1-887-367-4556
Emailcontact@InMode.com
Phone1-887-367-4556
Emailcontact@InMode.com
Phone1-887-367-4556
Emailcontact@InMode.com
Phone1-887-367-4556
Emailcontact@InMode.com
Phone1-887-367-4556
Emailcontact@InMode.com
Phone1-887-367-4556
Emailcontact@InMode.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016633382 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-03
Device Publish Date2022-10-26

On-Brand Devices [InMode ]

07290016633375InMode system - new hardware - color 1
07290016633252InMode system - new hardware
07290016633047InMode system
07290016633382InMode System 2 - color 2 The InMode Diolaze XL System with the Diolaze XL 810nm Hand piece is i

Trademark Results [InMode]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INMODE
INMODE
97266981 not registered Live/Pending
This Is Bien, Llc
2022-02-15
INMODE
INMODE
87570441 not registered Live/Pending
INMODE LTD
2017-08-15
INMODE
INMODE
73834523 1608756 Dead/Cancelled
SIZES UNLIMITED, INC.
1989-10-30

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