ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER)— 510(k) K182453

Name: FDA 510(k) clearance K182453
Creator: U.S. Food and Drug Administration
Published: 2019-01-11

Substantially Equivalent

I-Tech Industries Srl

FDA 510(k) clearance K182453 for ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER), Substantially Equivalent on 2019-01-11. 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: 2018-09-07
Decision date: 2019-01-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: San Lazzaro Di Savena, IT

Download summary PDF View on FDA.gov ↗

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