icoone Laser Healthcare

FDA UDI

Class I (US FDA UDI)

by I-Tech Industries Srl

Identity

Trade Name: icoone Laser Healthcare FDA UDI
Generic Name: Freestanding electric massager FDA UDI
Device Name: 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. FDA UDI
Model / Reference: ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: 601EC14 FDA UDI
Primary DI / UDI-DI: 18057592610246 FDA UDI
510(k) Number: K182453 FDA UDI
FDA Product Code: ISA FDA UDI
NUV FDA UDI
GMDN Term: Freestanding electric massager FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.5660 FDA UDI
878.4810 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

FDA UDI

Manufacturing Date

Yes

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Dimensions & Sizes

Size: Pressure — 20 KiloPascal FDA UDI

Category: Freestanding electric massager

icoone Laser Healthcare by I-Tech Industries Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: I-Tech Industries Srl

Sources (1)

FDA UDI 81fe91da-d351-4c10-a645-647bb1418279 38 fields · synced May 30, 2026