K-number	K182453
Device name	ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER)
Applicant	I-Tech Industries Srl
Product code	NUV
Device class	Class II
Decision date	Jan 11, 2019
Decision	Substantially Equivalent
Regulation	878.4810

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View the full FDA submission: accessdata.fda.gov

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ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER)

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ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER)