InMode RF hand piece HP172296A

GUDID 07290019863298

InModeRF HP 17x22x46 black

INMODE M.D LTD

Radio-frequency fat liquefaction system
Primary Device ID07290019863298
NIH Device Record Keyf3b32b5a-fcf2-46c1-8c73-2a1502f63043
Commercial Distribution StatusIn Commercial Distribution
Brand NameInMode RF hand piece
Version Model NumberHP172296A
Catalog NumberHP172296A
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
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 HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107290019863298 [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 Date2025-02-28
Device Publish Date2025-02-20

On-Brand Devices [InMode RF hand piece]

17290016633228HPL17D22 06A
17290016633211HPL10D13 InModeRF HP
07290016633405HPL17D22 46A
07290016633481AccuTite
07290016633467InMode RF Applicator
07290016633450InMode RF Applicator
07290019863052Handpiece comprises internal active electrode, external return electrode, both with temperature
07290019863045Handpiece comprises internal active electrode, external return electrode, both with temperature
07290019863298InModeRF HP 17x22x46 black
07290019863281FaceTite 2-Pack black
07290019863274AccuTite HP 2 Pack black

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.