ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER)
K-Number: K182453 · 2019-01-11
ApplicantI-Tech Industries Srl
Decision Date2019-01-11
Product CodeNUV
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER) is a medical device manufactured by I-Tech Industries Srl. It received FDA 510(k) clearance on 2019-01-11 under approval number K182453. The device is classified under product code NUV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER)?
ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER) is a medical device that received FDA 510(k) clearance on 2019-01-11. It is manufactured by I-Tech Industries Srl. The 510(k) number is K182453.
When was ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER) approved by the FDA?
ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER) received FDA 510(k) clearance on 2019-01-11, under approval number K182453.
What company makes ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER)?
ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER) is manufactured by I-Tech Industries Srl.
What is the FDA product code for ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER)?
The FDA product code for ICOONE h (also referred to as ICOONE LASER and ICOONE h LASER) is NUV.
Related Clinical Trials
Other Devices by I-Tech Industries Srl
Related Devices (Code: NUV)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.