Icoone Laser Body 611BC14

GUDID 18057592610369

Icoone Laser Body (also referred to as Icoone body laser) 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 611BC14) (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 (10mW) The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.

I-TECH INDUSTRIES SRL

Large-area electric massager

Primary Device ID	18057592610369
NIH Device Record Key	e50e4d2d-3f8c-4b8d-9f64-bf708aa790e6
Commercial Distribution Status	In Commercial Distribution
Brand Name	Icoone Laser Body
Version Model Number	Icoone laser body (also referred to as Icoone body
Catalog Number	611BC14
Company DUNS	440986833
Company Name	I-TECH INDUSTRIES SRL
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com
Phone	9149071850
Email	stan@skinsciencesolutions.com

Device Dimensions

Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal
Pressure	20 KiloPascal

Operating and Storage Conditions

Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 30 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 30 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	18057592610369 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K211272

FDA Product Code

ISA	Massager, Therapeutic, Electric

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-12-08
Device Publish Date	2023-11-30

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18057592610307 - Icoone Laser	2023-12-08 Icoone Laser (also referred to as Icoone Beauty Laser) is Therapeutic Massager machine attached to pivoting wheels, connected to
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18057592610369 - Icoone Laser Body	2023-12-08Icoone Laser Body (also referred to as Icoone body laser) 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 611BC14) (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 (10mW) The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.
18057592610369 - Icoone Laser Body	2023-12-08 Icoone Laser Body (also referred to as Icoone body laser) is Therapeutic Massager machine attached to pivoting wheels, connected