ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)
K-Number: K182453 · 2019-01-11
Device Summary
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. The listed applicant is I-Tech Industries Srl. The 510(k) number is K182453.
When did ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) receive FDA 510(k) clearance?
ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) received FDA 510(k) clearance on 2019-01-11, under 510(k) number K182453.
Who is the listed applicant for ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)?
The FDA 510(k) record lists I-Tech Industries Srl as the applicant. This does not by itself establish the device manufacturer.
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.
Other records listing I-Tech Industries Srl as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: NUV)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.