ICOONE Laser Med (also referred to as ICOONE Medical laser)— 510(k) K211272

Name: FDA 510(k) clearance K211272
Creator: U.S. Food and Drug Administration
Published: 2021-06-22

Substantially Equivalent

I-Tech Industries Srl

FDA 510(k) clearance K211272 for ICOONE Laser Med (also referred to as ICOONE Medical laser), Substantially Equivalent on 2021-06-22. Applicant: I-Tech Industries Srl. Device class: 2.

Clearance details

Applicant: I-Tech Industries Srl
Product code: Code NUV
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2021-04-27
Decision date: 2021-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bergamo, IT

Download summary PDF View on FDA.gov ↗

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