InMode RF hand piece HP253966A

GUDID 07290019863052

Handpiece comprises internal active electrode, external return electrode, both with temperature sensor, handle, cable and connector. Handpiece HP253966A has an active electrode diameter of 3.3mm and return electrode of 24mm diameter and 25cm long. Maximal RF power 60W.

INMODE M.D LTD

Radio-frequency fat liquefaction system
Primary Device ID07290019863052
NIH Device Record Key5e6784c3-b669-4c17-ba68-707118e74a5a
Commercial Distribution Discontinuation2024-04-25
Commercial Distribution StatusNot in Commercial Distribution
Brand NameInMode RF hand piece
Version Model NumberHP253966A
Catalog NumberHP253966A
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290019863052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-03
Device Publish Date2024-04-25

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07290019863052Handpiece comprises internal active electrode, external return electrode, both with temperature
07290019863045Handpiece comprises internal active electrode, external return electrode, both with temperature

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