skinsciencesolutions.comICOONE Laser Med (also referred to as ICOONE Medical laser)
I-Tech Industries Srl
I-TECH INDUSTRIES SRL
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013517454 | 3013517454 | I-TECH INDUSTRIES SRL | 1 | N | 2026-01-01 | Via I Maggio 4/Q Granarolo dell'Emilia Bologna IT 40057 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 08057592610676 | Icoone - icoone-M is a 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. | 9149071850 | stan@skinsciencesolutions.com |
| 18057592610246 | icoone Laser Healthcare - 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. | 9149071850 | stan@skinsciencesolutions.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 207133 | 1702365361 | K211272 | ICOONE Laser Med (also referred to as ICOONE Medical laser) | NUV | 2021-06-22 |
| 207133 | 2055042276 | K182453 | ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) | NUV | 2019-01-11 |
| 207133 | 1882825527 | ||||
| 207133 | 1916828454 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| NUV | 2 | 2021-06-22 |
PMN#
ICOONE H (also Referred To As ICOONE LASER And ICOONE –h LASER)
I-TECH INDUSTRIES SRL
GUDID#
Icoone - icoone-M is a 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.
2026-02-19
icoone Laser Healthcare - 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.
2023-11-30
icoone Healthcare - """Icoone, icoone Beauty, icoone h (also referred as icoone Healthcare) 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. """
2023-11-30
Icoone Medical - """Icoone, icoone Beauty, icoone h (also referred as icoone Medical) 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. """
2023-11-30
Icoone Laser Med - 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.
2023-11-30
Icoone Laser - Icoone Laser (also referred to as Icoone Beauty 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 610BEC04) (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.
2023-11-30
Icoone - Icoone, icoone Beauty, icoone h (also referred as icoone) 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.
2023-11-30
Icoone Laser Body - 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.
2023-11-30