AccessGUDID - DEVICE: FormaI (07290016633658)

GUDID

Device Identifier (DI) Information

Brand Name: FormaI
Version or Model: AG609417A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INMODE M.D LTD

Primary DI Number: 07290016633658
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600417351 *Terms of Use

Device Description: i-Forma Applicator applies RF energy through bipolar electrodes. The applicator has 2 RF electrodes, handle, cable, connector, and temperature sensors.

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:	No
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?
58455	Radio-frequency skin surface treatment system applicator	A handpiece component of a radio-frequency skin surface treatment system designed to be used by a healthcare professional to deliver bipolar radio-frequency (RF) energy to the skin surface for skin resurfacing. It is typically designed to deliver RF energy to the skin in a non-homogenous fractional manner, via an array of multi-electrode pins, to leave minimal-impact areas of skin to facilitate healing. The applicator connects with the system’s control unit and may include vacuum to facilitate its coupling with the skin. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories
PBX	Massager, Vacuum, Radio Frequency Induced Heat
ISA	Massager, Therapeutic, Electric
NUV	Massager, Vacuum, Light Induced Heating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210492	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 15 and 35 Degrees Celsius
Handling Environment Humidity: between 30 and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 90 and 110 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 686777a6-c4ff-405f-a803-c7bcb1854c36
Public Version Date: November 03, 2023
Public Version Number: 2
DI Record Publish Date: January 05, 2022