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ICOONE Laser Med

FDA 510(k)

Class II (US FDA 510(k))

510(k) K211272

by I-Tech Industries Srl

Identifiers

510(k) Number
K211272 FDA 510(k)
FDA Product Code
NUV FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

ICOONE Laser Med is a medical device classified as a Massager, Vacuum, Light Induced Heating. It is designed for use in clinics and medical practices to provide targeted action on scars, oedema, lymphoedema, fibrosis, muscle pain and post-operative recovery, improving tissue function and accelerating healing processes.

The device is supplied by I-Tech Industries Srl and has received FDA 510(k) clearance with product code NUV. It is intended for use in General and Plastic Surgery specialties. The device utilizes Roboderm® technology combining LASER and LED for its therapeutic effects.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: icoone® Laser Med: The Innovation for Non-Invasive Connective Tissue ..., ICOONE Laser Med (also referred to as ICOONE Medical… - FDA.report, icoone® Laser-Med — Flagship Medical Configuration, FDA 510 (k) K211272 ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
I-Tech Industries Srl

Sources (1)

  • FDA 510(k) K211272 24 fields · synced Oct 6, 2026