AccessGUDID - DEVICE: Icoone Laser Med (18057592610277)

GUDID

Device Identifier (DI) Information

Brand Name: Icoone Laser Med
Version or Model: ICOONE Laser Med (also called ICOONE MEDICAL LASER)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 650EC24
Company Name: I-TECH INDUSTRIES SRL

Primary DI Number: 18057592610277
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 440986833 *Terms of Use

Device Description: Icoone Medical Laser (also referred to as Icoone Lase med) is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body. The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading and stroking tissue by hand. Icoone Medical Laser (model ref 650EC24) (also referred to as Icoone Laser med) is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths: - Led @ 650nm (50mW) - Laser @ 915nm (1W) Through the display, the light sources can be fully deactivated, or both activated, or only LED activated. The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.

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?
35538	Freestanding electric massager	An electrically-powered benchtop, mobile, or stationary device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It may be in the form of a vibrating bed or a tabletop/freestanding unit with a massaging handpiece or other interchangeable mechanisms that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment; it may additionally provide heat. This device is intended for use in healthcare facilities and is not applicable to home therapies.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISA	Massager, Therapeutic, Electric
NUV	Massager, Vacuum, Light Induced Heating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211272	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 10 and 30 Degrees Celsius
Handling Environment Atmospheric Pressure: between 30 and 106 KiloPascal
Handling Environment Humidity: between 10 and 75 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Pressure: 20 KiloPascal

Device Record Status

Public Device Record Key: 2e83eca7-3650-4aee-8bd1-be567c6074bd
Public Version Date: June 06, 2024
Public Version Number: 2
DI Record Publish Date: November 30, 2023