InMode RF hand piece

Basic Information

• Brand Name: InMode RF hand piece
• Primary DI: 07290019863045
• Version / Model: HP102206A
• Catalog Number: HP102206A
• Company Name: INMODE M.D LTD
• Labeler DUNS: 600417351
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-25
• Public Version: 3
• Public Version Date: 2026-04-20
• Public Version Status: Update
• Public Device Record Key: 612224e9-f64c-4bf9-86af-8551275f9c48
• Distribution End Date: 2024-04-25

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

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290019863045	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K233642	000
K240780	000
K251254	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius