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510(k) Data Aggregation
K Number
K211272Device Name
ICOONE Laser Med (also referred to as ICOONE Medical laser)
Manufacturer
I-Tech Industries SRL
Date Cleared
2021-06-22
(56 days)
Product Code
NUV, ISA
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
I-Tech Industries SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ICOONE Laser med (also referred to as ICOONE Medical laser) is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
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 tissue by hand. Applications are pre-set by the machine or the operator in relation to intensity, frequency, length of session, degree of tissue suctioning, and allow to address the issues of each individual in an absolutely targeted manner. 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 @ 650mm (50mW) - Laser @ 915mm (1W) Through the display, the light sources can be fully deactivated, or only LED activated. The sources are neither adjustable in intensity (always output at nominal value, as per specifications) nor in frequency (always continuous - CW). Once selected, by turning on the Robosolo hand piece, both suctioning and light emission are activated at the same time. The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.
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K Number
K182453Device Name
ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER)
Manufacturer
I-TECH INDUSTRIES SRL
Date Cleared
2019-01-11
(126 days)
Product Code
NUV
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
I-TECH INDUSTRIES SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ICOONE h is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
Device Description
The Icoone-h device 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.
lcoone-h Laser 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 sources can be activated through the display, either combined or independently (only one of the two or both).
The sources are neither adjustable in intensity (always output at nominal value, as per specifications) nor in frequency (always continuous - CW).
Once selected, by turning on the Robosolo hand piece, both suctioning and light emission are activated at the same time.
The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.
Ask a Question
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