Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ICOONE Laser Med (also referred to as ICOONE Medical laser)

K-Number: K211272 · 2021-06-22

Decision Date2021-06-22
Product CodeNUV
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ICOONE Laser Med (also referred to as ICOONE Medical laser) is the device name listed in this FDA 510(k) record. The listed applicant is I-Tech Industries Srl. It received FDA 510(k) clearance on 2021-06-22 under 510(k) number K211272. 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 Laser Med (also referred to as ICOONE Medical laser)?

ICOONE Laser Med (also referred to as ICOONE Medical laser) is a medical device that received FDA 510(k) clearance on 2021-06-22. The listed applicant is I-Tech Industries Srl. The 510(k) number is K211272.

When did ICOONE Laser Med (also referred to as ICOONE Medical laser) receive FDA 510(k) clearance?

ICOONE Laser Med (also referred to as ICOONE Medical laser) received FDA 510(k) clearance on 2021-06-22, under 510(k) number K211272.

Who is the listed applicant for ICOONE Laser Med (also referred to as ICOONE Medical 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 Laser Med (also referred to as ICOONE Medical laser)?

The FDA product code for ICOONE Laser Med (also referred to as ICOONE Medical 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.