AccessGUDID - DEVICE: InMode RF hand piece (07290019863045)

GUDID

Device Identifier (DI) Information

Brand Name: InMode RF hand piece
Version or Model: HP102206A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: HP102206A
Company Name: INMODE M.D LTD

Primary DI Number: 07290019863045
Issuing Agency: GS1
Commercial Distribution End Date: April 25, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 600417351 *Terms of Use

Device Description: Handpiece comprises internal active electrode, external return electrode, both with temperature sensor, handle, cable and connector. Handpiece HP102206 has an active electrode diameter of 2mm and return electrode of 13.5mm diameter and 10cm long. Maximal RF power 20W.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
48005	Radio-frequency fat liquefaction system	An assembly of devices using radio-frequency (RF) energy for simultaneous adipose tissue liquefaction, blood vessel coagulation, and skin tightening during a radio-frequency-assisted liposuction (RFAL) procedure [lipectomy], typically performed for body contouring. The system consists of an RF-generating control unit that supplies RF energy to a dedicated applicator (handpiece) and provides continuous tissue temperature monitoring; impedance and power monitoring with tissue overheating safety systems; the RF applicator; and a foot-switch to control the RF energy supply. The liquified tissue is aspirated with an independent external suction system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K233642	000
K240780	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 612224e9-f64c-4bf9-86af-8551275f9c48
Public Version Date: August 09, 2024
Public Version Number: 2
DI Record Publish Date: April 25, 2024