icoone Laser Healthcare 601EC14

GUDID 18057592610246

Icoone h (also referred to as Icoone LASER and icoone-h 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 h (also referred to as Icoone LASER and icoone-h LASER) model ref 601EC14 is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths: - Led @ 650nm (50mW) - Laser @ 915nm (1W) The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.

I-TECH INDUSTRIES SRL

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• Primary Device ID: 18057592610246
• NIH Device Record Key: 81fe91da-d351-4c10-a645-647bb1418279
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: icoone Laser Healthcare
• Version Model Number: ICOONE h (also referred to as ICOONE LASER and ICO
• Catalog Number: 601EC14
• 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

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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	18057592610246 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182453

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

Devices Manufactured by I-TECH INDUSTRIES SRL

• 18057592610246 - icoone Laser Healthcare: 2023-12-08Icoone h (also referred to as Icoone LASER and icoone-h 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 h (also referred to as Icoone LASER and icoone-h LASER) model ref 601EC14 is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths: - Led @ 650nm (50mW) - Laser @ 915nm (1W) The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.
• 18057592610246 - icoone Laser Healthcare: 2023-12-08 Icoone h (also referred to as Icoone LASER and icoone-h LASER) is Therapeutic Massager machine attached to pivoting wheels, conn
• 18057592610253 - icoone Healthcare: 2023-12-08 "Icoone, icoone Beauty, icoone h (also referred as icoone Healthcare) is Therapeutic Massager machine attached to pivoting wheel
• 18057592610260 - Icoone Medical: 2023-12-08 "Icoone, icoone Beauty, icoone h (also referred as icoone Medical) is Therapeutic Massager machine attached to pivoting wheels,
• 18057592610277 - Icoone Laser Med: 2023-12-08 Icoone Medical Laser (also referred to as Icoone Lase med) is Therapeutic Massager machine attached to pivoting wheels, connecte
• 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
• 18057592610321 - Icoone: 2023-12-08 Icoone, icoone Beauty, icoone h (also referred as icoone) is Therapeutic Massager machine attached to pivoting wheels, connected
• 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