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Icoone Laser Med

FDA UDI

Class I (US FDA UDI)

by I-Tech Industries Srl

Identity

Trade Name
Icoone Laser Med FDA UDI
Generic Name
Freestanding electric massager FDA UDI
Device Name
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. FDA UDI
Model / Reference
ICOONE Laser Med (also called ICOONE MEDICAL LASER) FDA UDI
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 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. FDA UDI

Identifiers

Catalog Number
650EC24 FDA UDI
Primary DI / UDI-DI
18057592610277 FDA UDI
510(k) Number
K211272 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Pressure — 20 KiloPascal FDA UDI

Category: Freestanding electric massager

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

Similar devices

Also classified as Freestanding electric massager.

Cleared under the same submission

K211272 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
I-Tech Industries Srl

Sources (1)

  • FDA UDI 2e83eca7-3650-4aee-8bd1-be567c6074bd 38 fields · synced May 29, 2026